Published on in Vol 5, No 5 (2021): May

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/20779, first published .
Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial

Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial

Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial

Original Paper

1Rijnstate, Arnhem, Netherlands

2Department of Health Technology and Services Research, University of Twente, Enschede, Netherlands

3Pulmonary Department, Rijnstate, Arnhem, Netherlands

4Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, Netherlands

Corresponding Author:

Wim H van Harten, MD, PhD

Rijnstate

Wagnerlaan 55

Arnhem

Netherlands

Phone: 31 088 0058888

Email: WvanHarten@Rijnstate.nl


Background: The effectiveness of continuous positive airway pressure (CPAP) is dependent on the degree of use, so adherence is essential. Cognitive components (eg, self-efficacy) and support during treatment have been found to be important in CPAP use. Video consultation may be useful to support patients during treatment. So far, video consultation has rarely been evaluated in thorough controlled research, with only a limited number of outcomes assessed.

Objective: The aim of the study was to evaluate the superiority of video consultation over face-to-face consultation for patients with obstructive sleep apnea (OSA) on CPAP use (minutes per night), adherence, self-efficacy, risk outcomes, outcome expectancies, expectations and experiences with video consultation, and satisfaction of patients and nurses.

Methods: A randomized controlled trial was conducted with an intervention (video consultation) and a usual care group (face-to-face consultation). Patients with confirmed OSA (apnea-hypopnea index >15), requiring CPAP treatment, no history of CPAP treatment, having access to a tablet or smartphone, and proficient in the Dutch language were recruited from a large teaching hospital. CPAP use was monitored remotely, with short-term (weeks 1 to 4) and long-term (week 4, week 12, and week 24) assessments. Questionnaires were completed at baseline and after 4 weeks on self-efficacy, risk perception, outcome expectancies (Self-Efficacy Measure for Sleep Apnea), expectations and experiences with video consultation (covering constructs of the unified theory of acceptance and use of technology), and satisfaction. Nurse satisfaction was evaluated using questionnaires.

Results: A total of 140 patients were randomized (1:1 allocation). The use of video consultation for OSA patients does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. A significant difference in change over time was found between groups for short-term (P-interaction=.008) but not long-term (P-interaction=.68) CPAP use. CPAP use decreased in the long term (P=.008), but no significant difference was found between groups (P=.09). Change over time for adherence was not significantly different in the short term (P-interaction=.17) or long term (P-interaction=.51). A relation was found between CPAP use and self-efficacy (P=.001), regardless of the intervention arm (P=.25). No significant difference between groups was found for outcome expectancies (P=.64), self-efficacy (P=.41), and risk perception (P=.30). The experiences were positive, and 95% (60/63) intended to keep using video consultation. Patients in both groups rated the consultations on average with an 8.4. Overall, nurses (n=3) were satisfied with the video consultation system.

Conclusions: Support of OSA patients with video consultation does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. The findings of this research suggest that self-efficacy is an important factor in improving CPAP use and that video consultation may be a feasible way to support patients starting CPAP. Future research should focus on blended care approaches in which self-efficacy receives greater emphasis.

Trial Registration: Clinicaltrials.gov NCT04563169; https://clinicaltrials.gov/show/NCT04563169

JMIR Form Res 2021;5(5):e20779

doi:10.2196/20779

Keywords



Telemedicine is increasingly used to support self-management in chronic diseases and is defined as the use of information and communication technology to deliver health care at a distance [Verbraecken J. Telemedicine applications in sleep disordered breathing: thinking out of the box. Sleep Med Clin 2016 Dec;11(4):445-459 [FREE Full text] [CrossRef] [Medline]1], but so far we see little evidence in this field. Nevertheless, telemedicine solutions are used for patients with obstructive sleep apnea (OSA) for example, for monitoring, education, and consultation [Bruyneel M. Telemedicine in the diagnosis and treatment of sleep apnoea. Eur Respir Rev 2019 Mar 31;28(151):180093 [FREE Full text] [CrossRef] [Medline]2]. OSA is considered a chronic disease [Verbraecken J. Telemedicine applications in sleep disordered breathing: thinking out of the box. Sleep Med Clin 2016 Dec;11(4):445-459 [FREE Full text] [CrossRef] [Medline]1,Epstein LJ, Kristo D, Strollo PJ, Friedman N, Malhotra A, Patil SP, Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009 Jun 15;5(3):263-276 [FREE Full text] [Medline]3]; it is a sleep disorder that affects at least 2% to 4% of the adult population [Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008 Feb 15;5(2):136-143 [FREE Full text] [CrossRef] [Medline]4] and is characterized by repeated episodes of full or partial occlusion of the upper airway during sleep [Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008 Feb 15;5(2):136-143 [FREE Full text] [CrossRef] [Medline]4,Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, American Academy of Sleep Medicine. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep 2006 Mar;29(3):375-380. [CrossRef] [Medline]5]. This condition can have multiple effects on patients’ health such as cognitive dysfunction [Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008 Feb 15;5(2):136-143 [FREE Full text] [CrossRef] [Medline]4], decrease in health-related quality of life [Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008 Feb 15;5(2):136-143 [FREE Full text] [CrossRef] [Medline]4,Gay P, Weaver T, Loube D, Iber C, Positive Airway Pressure Task Force, Standards of Practice Committee, American Academy of Sleep Medicine. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. Sleep 2006 Mar;29(3):381-401. [CrossRef] [Medline]6], increase in cardiovascular disease risk, and sleepiness during the daytime [Gay P, Weaver T, Loube D, Iber C, Positive Airway Pressure Task Force, Standards of Practice Committee, American Academy of Sleep Medicine. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. Sleep 2006 Mar;29(3):381-401. [CrossRef] [Medline]6]. The severity is often determined with the apnea-hypopnea index (AHI) [Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008 Feb 15;5(2):136-143 [FREE Full text] [CrossRef] [Medline]4], which represents the number of apneas and hypopneas per hour [Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc 2008 Feb 15;5(2):136-143 [FREE Full text] [CrossRef] [Medline]4] and is classified as mild (5 to 15 per hour), moderate (15 to 30 per hour) or severe (>30 per hour) [American Academy of Sleep Medicine Task Force. Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. Sleep 1999 Aug 01;22(5):667-689. [Medline]7]. Continuous positive airway pressure (CPAP) is the preferred treatment [Gay P, Weaver T, Loube D, Iber C, Positive Airway Pressure Task Force, Standards of Practice Committee, American Academy of Sleep Medicine. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. Sleep 2006 Mar;29(3):381-401. [CrossRef] [Medline]6], especially for moderate to severe OSA [Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, American Academy of Sleep Medicine. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep 2006 Mar;29(3):375-380. [CrossRef] [Medline]5]. CPAP prevents the airway from narrowing or collapsing by applying a positive pressure via a nasal mask during sleep [Gibson GJ. Obstructive sleep apnoea syndrome: underestimated and undertreated. Br Med Bull 2004;72:49-65. [CrossRef] [Medline]8] and is tailored to each patient [Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet 1981 Apr 18;1(8225):862-865. [CrossRef] [Medline]9]. As the effectiveness of CPAP is dependent on use [Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, American Academy of Sleep Medicine. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep 2006 Mar;29(3):375-380. [CrossRef] [Medline]5,Stuck BA, Leitzbach S, Maurer JT. Effects of continuous positive airway pressure on apnea-hypopnea index in obstructive sleep apnea based on long-term compliance. Sleep Breath 2012 Jun;16(2):467-471. [CrossRef] [Medline]10], treatment adherence is essential. Cognitive components, mainly based on the social cognitive theory [Bandura A. Self-efficacy mechanism in human agency. Am Psychol 1982;37(2):122-147. [CrossRef]11], are becoming increasingly important in predicting CPAP use [Stepnowsky CJ, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med 2002 May;3(3):239-247. [CrossRef] [Medline]12-Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med 2005 Oct 15;1(4):346-353. [Medline]14]. Support during treatment [Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev 2011 Dec;15(6):343-356 [FREE Full text] [CrossRef] [Medline]15], tailored interventions [Mehrtash M, Bakker JP, Ayas N. Predictors of continuous positive airway pressure adherence in patients with obstructive sleep apnea. Lung 2019 Apr;197(2):115-121. [CrossRef] [Medline]16], and closer follow-up [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17] can also positively affect adherence.

Video consultation may be a useful way to support patients [Verbraecken J. Telemedicine applications in sleep disordered breathing: thinking out of the box. Sleep Med Clin 2016 Dec;11(4):445-459 [FREE Full text] [CrossRef] [Medline]1,Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18] during treatment and is defined as a “technology used to realize a real-time visual and audio patient assessment at a distance” [Kitamura C, Zurawel-Balaura L, Wong RKS. How effective is video consultation in clinical oncology? A systematic review. Curr Oncol 2010 Jun;17(3):17-27 [FREE Full text] [CrossRef] [Medline]19]. Video consultation has been beneficial in chronic conditions (eg, diabetes [Fatehi F, Martin-Khan M, Smith AC, Russell AW, Gray LC. Patient satisfaction with video teleconsultation in a virtual diabetes outreach clinic. Diabetes Technol Ther 2015 Jan;17(1):43-48. [CrossRef] [Medline]20,Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: a randomized trial in an outpatient clinic. J Telemed Telecare 2016 Sep;22(6):363-368. [CrossRef] [Medline]21] and cancer [Kitamura C, Zurawel-Balaura L, Wong RKS. How effective is video consultation in clinical oncology? A systematic review. Curr Oncol 2010 Jun;17(3):17-27 [FREE Full text] [CrossRef] [Medline]19,Sabesan S, Simcox K, Marr I. Medical oncology clinics through videoconferencing: an acceptable telehealth model for rural patients and health workers. Intern Med J 2012 Jul;42(7):780-785. [CrossRef] [Medline]22]) and in care for OSA patients [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18]. The use for OSA patients may be promising, especially since physical examination is not always needed [Verbraecken J. Telemedicine applications in sleep disordered breathing: thinking out of the box. Sleep Med Clin 2016 Dec;11(4):445-459 [FREE Full text] [CrossRef] [Medline]1], and CPAP use can already be monitored remotely [Slaapmasker. Rijnstate.   URL: https://www.rijnstate.nl/aandoening-en-behandeling/slaapapneu/behandeling/slaapmasker/ [accessed 2020-10-24] 23]. However, the evidence on the effectiveness for OSA patients is still limited [Murphie P, Little S, McKinstry B, Pinnock H. Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review. J Telemed Telecare 2019 Jan;25(1):17-25. [CrossRef] [Medline]24]. Previous studies were narrowly focused, with mainly adherence [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25] and satisfaction [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26] being assessed. Although cognitive components, (eg, self-efficacy and outcome expectancies) are found to be important elements for CPAP use [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13,Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med 2005 Oct 15;1(4):346-353. [Medline]14,Stepnowsky CJ, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med 2002 May;3(3):239-247. [CrossRef] [Medline]27], there is a lack of evidence about these effects on video consultation for OSA patients. Previous research on OSA patients also mainly evaluated the use of video consultation for initial contact with health care professionals focused on diagnosis, treatment plans [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26], or for training purposes [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17]. The use of video consultation may be particularly relevant during follow-up (after an initial face-to-face contact) for newly diagnosed patients, since support during treatment is important [Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev 2011 Dec;15(6):343-356 [FREE Full text] [CrossRef] [Medline]15] and successful CPAP use is often determined at an early stage of treatment [Weaver TE, Kribbs NB, Pack AI, Kline LR, Chugh DK, Maislin G, et al. Night-to-night variability in CPAP use over the first three months of treatment. Sleep 1997 Apr;20(4):278-283. [CrossRef] [Medline]28].

Only a limited number of randomized controlled trials (RCTs) were conducted [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26,Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29], with only one fully powered trial [Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29]. In a study by Smith et al [Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25], video consultation was used by nurses for patients who were nonadherent during the first 3 months of treatment. One group of patients received specific information (n=10) about CPAP and one group (n=9) generic information. Both adherence and satisfaction were higher in the intervention group (P=.003). Isetta et al [Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29] conducted a multicenter RCT with patients receiving access to either a telemedicine program (n=69) with video consultations or usual care (hospital visits, n=70). Although the telemedicine approach was assumed to be more cost-effective, CPAP adherence was equivalent after 6 months [Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29]. Video consultation was also used for initial contact before starting treatment, with mixed results. The use of video consultation for training purposes did not lead to a difference in knowledge [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17]. Also, no significant differences in satisfaction and CPAP adherence were found after 14 days for new OSA patients starting CPAP treatment [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18]. Adherence rates were found to be higher after 6 months for patients who received their initial consultation face-to-face than via video consultation. However, statistically significant difference was not reported [Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26].

Video consultation is often found to be as effective as face-to-face consultation in terms of CPAP use [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29]. Previous studies often focused on newly diagnosed patients before the start of treatment [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26], with generally small sample sizes [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26]. Patients are satisfied with video consultation [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25], and it may be a promising way to deliver more convenient care with indirect benefits for patients (eg, less travel time) [Murphie P, Little S, McKinstry B, Pinnock H. Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review. J Telemed Telecare 2019 Jan;25(1):17-25. [CrossRef] [Medline]24]. Additionally, remote monitoring [Chen C, Wang J, Pang L, Wang Y, Ma G, Liao W. Telemonitor care helps CPAP compliance in patients with obstructive sleep apnea: a systemic review and meta-analysis of randomized controlled trials. Ther Adv Chronic Dis 2020;11:2040622320901625 [FREE Full text] [CrossRef] [Medline]30] and patient support treatment [Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, et al. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J 2014 Nov;44(5):1262-1274 [FREE Full text] [CrossRef] [Medline]31] can positively affect CPAP use [Chen C, Wang J, Pang L, Wang Y, Ma G, Liao W. Telemonitor care helps CPAP compliance in patients with obstructive sleep apnea: a systemic review and meta-analysis of randomized controlled trials. Ther Adv Chronic Dis 2020;11:2040622320901625 [FREE Full text] [CrossRef] [Medline]30,Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, et al. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J 2014 Nov;44(5):1262-1274 [FREE Full text] [CrossRef] [Medline]31]. Therefore, it may be expected that video consultation in combination with remotely monitoring CPAP use, consultation with nurses, and the indirect benefits of video consultation (eg, less travel time) [Murphie P, Little S, McKinstry B, Pinnock H. Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review. J Telemed Telecare 2019 Jan;25(1):17-25. [CrossRef] [Medline]24] may improve CPAP use. Cognitive components (eg, self-efficacy) are also found to be important elements for CPAP use [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13,Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med 2005 Oct 15;1(4):346-353. [Medline]14,Stepnowsky CJ, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med 2002 May;3(3):239-247. [CrossRef] [Medline]27], but evaluation in combination with video consultation is lacking [Murphie P, Little S, McKinstry B, Pinnock H. Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review. J Telemed Telecare 2019 Jan;25(1):17-25. [CrossRef] [Medline]24]. More evidence about the technology being used and health care professionals’ perceptions is also needed to ensure successful implementations [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17]. Such knowledge is essential because the use of video consultation is increasing, but evidence is still lacking and powered studies are needed [Murphie P, Little S, McKinstry B, Pinnock H. Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review. J Telemed Telecare 2019 Jan;25(1):17-25. [CrossRef] [Medline]24].

Therefore, the objective of this paper is to evaluate the superiority of video consultation versus face-to-face consultation for patients with OSA on CPAP use (minutes per night), CPAP adherence, self-efficacy, risk perception, outcome expectancy, video consultation expectations and experiences with technology, and the satisfaction of patients and nurses.


Study Design

We conducted a nonblinded RCT with an intervention group (video consultation) and a usual care group (face-to-face consultation), with 1:1 allocation.

Recruitment and Participants

Patients were recruited from a large teaching hospital (Rijnstate, Arnhem). To be eligible to participate, patients had to be older than 18 years, be diagnosed with moderate or severe OSA (AHI >15), require CPAP treatment, have no history of CPAP treatment, have access to a tablet or smartphone, and be proficient in the Dutch language. Exclusion criteria were having a psychiatric or cognitive disorder.

Study Process

Prior to the study, a letter was sent to patients to confirm their appointments (eg, sleep study and consultation with the pulmonologist) including information about the study. During the first face-to-face consultation with the pulmonologist, patients received their treatment plan and information about the study (including information letter and informed consent form). This was followed by instruction about their CPAP treatment. After this consultation, the researcher provided patients with additional information about the study, and they were asked to sign the informed consent form. For reasons of clinical necessity, patients started treatment the same day.

Randomization

After patients signed informed consent and completed the baseline questionnaire, they were randomized by the researcher to the intervention or usual care group using the software program Research Manager (Cloud9 Software) with block size of 10. The researcher informed the patients about their allocation, and the intervention group received additional information about the video consultation app (Facetalk, Qconferencing) [Facetalk.   URL: https://facetalk.nl/ [accessed 2021-04-24] 32]. All participants received a copy of the informed consent form, and a follow-up appointment was planned directly.

Intervention

The video consultation app Facetalk [Facetalk.   URL: https://facetalk.nl/ [accessed 2021-04-24] 32] could be downloaded (for free) from Google Play [Facetalk. Google Play.   URL: https://play.google.com/store/apps/details?id=nl.facetalk.mobile&hl=nl&gl=US [accessed 2020-10-24] 33] or the App Store [Facetalk. App Store.   URL: https://apps.apple.com/nl/app/facetalk/id1178990857 [accessed 2020-10-24] 34]. The first video consultation with a nurse was planned for 1 week after the start of CPAP. Patients received an email with the date, time, and a link to start the video consultation in the app. Three focus points were discussed during the consultations: (1) adherence (>6 hours per night), (2) rest AHI <5 (or <10 if age over 70 years), and (3) (improvements in) symptoms. If these objectives were achieved after 1 week, a new consultation was planned for 3 weeks later (4 weeks after the start). If these objectives were not achieved, video consultations were planned for weekly (until 4 weeks after starting CPAP treatment). After 4 weeks, patients received a questionnaire. See

Multimedia Appendix 1

Study process.

PNG File , 61 KBMultimedia Appendix 1 for the study process.

Usual Care

The usual care group followed the same care process but with face-to-face consultation instead of video consultation. Patients received a confirmation letter with the day and time of their next consultation.

Outcome Measures

Primary Outcome

The primary outcome was CPAP use (minutes per night), monitored remotely with Encore Anywhere (Philips). Conforming to the initial protocol, CPAP use was assessed during the first 4 weeks (short-term). Additionally, we assessed CPAP use after week 4, week 12, and week 24 (long-term).

Secondary Outcomes
CPAP Adherence

CPAP adherence was defined as CPAP use for at least 5 nights per week for at least 4 hours per night [Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev 2011 Dec;15(6):343-356 [FREE Full text] [CrossRef] [Medline]15,Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: implications for future interventions. Indian J Med Res 2010 Feb;131:245-258 [FREE Full text] [Medline]35] and was assessed during the first 4 weeks (short-term) and week 4, week 12, and week 24 (long-term).

Treatment Self-Efficacy, Risk Perception, and Outcome Expectancies

The Self-Efficacy Measure for Sleep Apnea (SEMSA) [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13] was used to measure cognitive components: self-efficacy, risk perception, and outcome expectancies. The SEMSA is a 26-item scale [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13] with subscales: self-efficacy and outcome expectancies each have 9 questions rated on a 4-point scale from not at all true to very true and risk perception has 8 questions rated on a 4-point scale from very low to very high. The mean of the nonmissing item responses was calculated for risk perception, outcome expectancies, and self-efficacy. For the purpose of this study, the SEMSA was translated back (from English into Dutch) and forth (from Dutch into English) by Taalcentrum-VU [Taalcentrum-VU. Vertaalbureau Amsterdam.   URL: https://www.taalcentrum-vu.nl/vertaalbureau/ [accessed 2020-10-24] 36]. In this study, the statements from the published paper were used [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13].

Relation Between Self-Efficacy, Risk Perception, Outcome Expectancies, and CPAP Use

The relations between CPAP use and self-efficacy, risk perception, and outcome expectancies were assessed. Also, the differences between the intervention and usual care group were analyzed.

Expectations and Experiences With Video Consultation

Questions covering constructs of the unified theory of acceptance and use of technology (UTAUT) model [Venkatesh, Morris, Davis, Davis. User acceptance of information technology: toward a unified view. MIS Quarterly 2003;27(3):425. [CrossRef]37] were used to measure expectations and experiences with the use of the video consultation system. The UTAUT consists of 4 constructs that influence behavioral intention and behavior—performance expectancy, effort expectancy, social influence, and facilitating conditions [Venkatesh, Morris, Davis, Davis. User acceptance of information technology: toward a unified view. MIS Quarterly 2003;27(3):425. [CrossRef]37]. A total of 9 questions were rated on a 7-point scale (1=totally disagree to 7=totally agree).

Satisfaction

Patient satisfaction was evaluated with questions about the consultations and information received. Additionally, the intervention group answered questions about the video consultation system. All questions were rated on a 5-point scale (from 1=totally disagree to 5=totally agree). Nurses’ experiences were evaluated using a questionnaire with questions about the video consultation system, satisfaction, and organizational benefits (eg, time and efficiency).

Other Parameters

Patient age, marital status, education, experience with internet and internet use, tablet or smartphone skills, and support (with tablet or smartphone use) were assessed via a questionnaire at baseline. Data about comorbidities, AHI, number of consultations, symptoms, and results of the Epworth Sleepiness Scale [Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991 Dec;14(6):540-545. [Medline]38] were obtained from the electronic medical record. This scale is a self-administered questionnaire to examine the perception of daytime sleepiness that has 8 questions about how likely it is to doze off in different situations ranging from 0 to 3. A total score for this scale is calculated by taking the sum of the 8 items. A total of 11 to 12 is considered mild, 13 to 15 moderate, and 16 to 24 severe excessive daytime sleepiness [Johns M. The Epworth Sleepiness Scale.   URL: https://epworthsleepinessscale.com/about-the-ess/ [accessed 2019-12-03] 39]. In this study, a total score of >10 is considered excessive daytime sleepiness.

Sample Size Calculation

Since there is no determined clinically relevant difference for CPAP use [Aardoom JJ, Loheide-Niesmann L, Ossebaard HC, Riper H. Effectiveness of eHealth interventions in improving treatment adherence for adults with obstructive sleep apnea: meta-analytic review. J Med Internet Res 2020 Feb 18;22(2):e16972 [FREE Full text] [CrossRef] [Medline]40], we assumed that a difference of 1 (SD 2.0) hour per day of average CPAP use (primary outcome) is clinically significant [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13,Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29]. Using a t test, alpha of .05, and 80% power, 63 subjects per group (a total of 126) were needed. Correcting for 10% dropout, 70 patients were recruited for each group.

Statistical Analysis

Data analysis was performed using SPSS (version 22.0, IBM Corp). Descriptive statistics were used to report the baseline characteristics, experiences, expectations, and satisfaction. Linear mixed models were used to analyze differences in CPAP use over time for the intervention and usual care group (interaction term: time × group). All available CPAP use data were used in the analysis, according to the intention-to-treat principle. Differences in adherence over time between groups was analyzed using generalized estimating equations. The relation between CPAP use and risk perception, outcome expectancies, and self-efficacy was analyzed with a linear regression. Normally distributed variables were reported as mean and standard deviation, and statistical differences were tested using an independent samples t test. Nonnormally distributed data were reported with medians and interquartile range (25th to 75th percentiles), and differences between groups were analyzed with Mann-Whitney U tests.

Approval and Ethical Considerations

All participants signed a written informed consent form prior to inclusion in the study. The study was approved by the regional medical research ethics committee Commissie Mensgebonden Onderzoek Arnhem–Nijmegen and registered at Clinicaltrials.gov [NCT04563169].


Recruitment and Participants

Patients were included from January 2, 2019, until June 26, 2019. In total, 222 patients were screened for eligibility, and 50 patients did not meet the inclusion criteria: no tablet or smartphone (n=17), no proficiency in the Dutch language (n=10), AHI <15 (n=10), history of CPAP treatment (n=5), no OSA (n=4), psychiatric or cognitive disorder (n=3), and age <18 years (n=1). In total, 28 patients declined to participate, and 4 patients were not informed about the study for other reasons: 2 patients were not referred to the researcher due to logistical errors, 1 patient followed a different care process (there was no consultation with the pulmonologist that same day), and 1 patient had had CPAP for try out for a short period.

In total, 140 patients were randomized, and 70 patients were allocated to the intervention group and 70 patients to the usual care group. During the intervention period, 2 patients discontinued the intervention: 1 preferred face-to-face consultation, and 1 had no working device. Four patients stopped CPAP treatment during the intervention period (first 4 weeks). In total, 10 patients were lost to follow-up in the intervention group (n=9 stopped CPAP treatment and n=1 died) and 3 in the usual care group (n=3 stopped CPAP treatment). See Figure 1 for the CONSORT (Consolidated Standards of Reporting Trials) flow diagram.

Figure 1. CONSORT flow diagram.
View this figure

Baseline Characteristics

Both groups had similar baseline characteristics (Table 1), only outcome expectancies (P=.048) and risk perception (P=.02) appeared to be significantly different between groups.

Table 1. Baseline characteristics (n=140).
CharacteristicsAll patients (n=140)Intervention (n=70)Usual care (n=70)P value
Gender, women, n (%)29 (21)12 (17)17 (24).30
Age (years), mean (SD)53.3 (12.1)52.3 (12.4)54.3 (11.9).40
AHIa, median (IQR)31.0 (21.5-45.0)31.0 (22.0-46.0)30.5 (20.0-42.0).96
Living with a partner, n (%)110 (79)59 (84)51 (73).10
Education, n (%)b.22

Low8 (6)3 (4)5 (7)

Middle89 (64)41 (59)48 (69)

High43 (31)26 (37)17 (24)
Internet use: duration, n (%)>.99

<6 months3 (2)1 (1)2 (3)

1-2 years1 (1)1 (1)0 (0)

>2 years1 (1)1 (1)0 (0)

>3 years135 (96)67 (96)68 (97)
Internet use: frequency, n (%).31

(almost) every day128 (91)66 (94)62 (89)

Multiple days per week9 (6)4 (6)5 (7)

≤1 day per week3 (2)0 (0)3 (4)
Tablet or smartphone skills, n (%).91

Quite bad or bad5 (4)2 (3)3 (4)

Not good or not bad23 (16)11 (16)12 (17)

Quite good27 (19)14 (20)13 (19)

Good55 (39)26 (37)29 (41)

Very good30 (21)17 (24)13 (19)
Expects to need help with tablet or smartphone use, n (%)26 (19)11 (16)15 (22).41
Comorbidities, n (%)

Obesity (BMI >30)97 (69)51 (73)46 (66).36

Hypertension48 (34)24 (34)24 (34)>.99

Hypercholesterolemia21 (15)8 (11)13 (19).24

Heart disease20 (14)11 (16)9 (13).63

Diabetes14 (10)7 (10)7 (10)>.99
ESSc score, n (%).19

Total score ≤10105 (79)56 (84)49 (74)

Total score >1028 (21)11 (16)17 (26)
SEMSAd constructs

Outcome expectancies, mean (SD)2.78 (0.62)2.88 (0.57)2.67 (0.65).048

Self-efficacy, median (IQR)3.00 (2.56-3.56)3.00 (2.56-3.33)3.00 (2.56-3.67).40

Risk perception, median (IQR)2.00 (1.54-2.50)2.31 (1.63-2.63)1.88 (1.50-2.31).02

aAHI: apnea-hypopnea index.

bNot applicable.

cESS: Epworth Sleepiness Scale.

dSEMSA: Self-Efficacy Measure for Sleep Apnea.

CPAP Use

The use of video consultation does not lead to superior results on CPAP use compared with face-to-face consultation. A significant difference in change over time was found between groups for short-term (weeks 1 through 4) CPAP use (P-interaction=.008). However, the specific time points (week 1: P=.62; week 2: P=.15; week 3: P=.33, and week 4: P=.20) were not significantly different. See

Multimedia Appendix 2

Short-term CPAP use.

DOC File , 30 KBMultimedia Appendix 2 and

Multimedia Appendix 3

Short-term CPAP use: change over time.

PNG File , 70 KB
Multimedia Appendix 3
for more detailed information on short-term CPAP use.

No significant difference in change over time for long-term CPAP use (week 4, week 12, and week 24) was found between groups (P-interaction=.68). CPAP use decreased for both groups in the long term (P=.008), but no significant difference was found between the intervention and usual care group (P=.09). See Table 2 and Figure 2 for change in CPAP use over time (week 4, week 12, and week 24).

Table 2. Long-term continuous positive airway pressure use (minutes per night).
WeekaInterventionUsual care

EMMb (SE)95% CIEMM(SE)95% CI
Week 4334.3 (16.3)302.1-366.5371.4 (15.8)340.1-402.7
Week 12311.5 (16.8)278.4-344.6348.6 (16.2)316.5-380.7
Week 24295.2 (17.8)260.0-330.4332.7 (17.3)298.1-366.5

aLinear mixed model.

bEMM: estimated marginal mean.

Figure 2. Long-term continuous positive airway pressure use: change over time.
View this figure

CPAP Adherence

The use of video consultation does not lead to superior results on CPAP adherence compared with face-to-face consultation. No significant difference was found between both groups for short-term (P=.95) and long-term (P=.12) CPAP adherence. Also, no significant difference in change over time between the intervention and usual care group was found for short-term (P-interaction=.17) and long-term (P-interaction=.51) CPAP adherence. See

Multimedia Appendix 4

Short-term CPAP adherence.

DOC File , 29 KBMultimedia Appendix 4 and

Multimedia Appendix 5

Long-term CPAP adherence.

DOC File , 29 KB
Multimedia Appendix 5
for the short-term and long-term adherence rates per week.

Self-Efficacy, Risk Outcomes, and Outcome Expectancies

No significant difference between groups was found for the SEMSA constructs: outcome expectancies (P=.64), self-efficacy (P=.41), and risk perception (P=.30). See

Multimedia Appendix 6

Self-Efficacy Measure for Sleep Apnea constructs: self-efficacy, risk perception, and outcome expectancies.

DOC File , 29 KBMultimedia Appendix 6.

Relation Between Self-Efficacy, Risk Perception, Outcome Expectancies, and CPAP Use

After 4 weeks, a relation was found between CPAP use and self-efficacy (P=.001), meaning that patients with higher levels of self-efficacy showed higher CPAP use. There was no relation between CPAP use and risk perception (P=.34) or outcome expectancies (P=.76). Also, the difference between the intervention and usual care group was not significant (P=.25).

Expectations and Experiences With Video Consultation

Patients expressed positive expectations for the use of video consultation. After 4 weeks, 76% (48/63) indicated that video consultation had a positive effect on control over their treatment, and 75% (47/63) indicated that it positively affected the treatment itself. The majority (58/63, 92%) implied it did not cost them effort, 95% (60/63) reported that they had enough skills to use a tablet or smartphone and that they received enough support (53/63, 84%). Although, 64% (44/69) expected to be stimulated by people in their direct environment to use video consultation, only 25% (16/63) were actually stimulated. Almost all patients (60/63, 95%) intended to keep using video consultation. See

Multimedia Appendix 7

Expectations and experiences with video consultation.

DOC File , 38 KBMultimedia Appendix 7.

Satisfaction With Consultation

Patients in both groups were satisfied with the consultations. On average, the intervention group rated the consultations with an 8.5 and the usual care group with an 8.3 on a scale of 1 to 10 (1=not at all satisfied to 10=very satisfied). Patients indicated (intervention group versus usual care group) that health care professionals understood their problems (59/63, 94%, vs 58/68, 85%) and listened to them (60/63, 95%, vs 61/68, 90%). Almost all patients understood the content of the consultation (61/63, 97%, vs 62/68, 91%), could easily express their feelings (59/63, 94%, vs 62/68, 91%), and were satisfied with the information they received (58/63, 92%, vs 60/68, 88%). However, more patients with video consultation reported that they did not miss important information (56/63, 89%, vs 43/68, 63%). See

Multimedia Appendix 8

Patient satisfaction with consultation.

DOC File , 36 KBMultimedia Appendix 8.

Satisfaction With Video Consultation

The majority (56/63, 89%) of the patients were very satisfied with video consultation, the quality of the video (50/63, 79%), and sound of the system (45/63, 71%). It also saved them time (61/63, 97%) and provided better access to health care professionals (43/63, 68%). Almost all patients felt safe about their privacy and confidentiality (61/63, 97%) and preferred a video consultation over a face-to-face consultation (51/63, 81%). According to almost half (28/63, 44%) the patients, face-to-face consultation can be replaced by video consultation. See

Multimedia Appendix 9

Patient satisfaction with video consultation.

DOC File , 36 KBMultimedia Appendix 9.

Nurse Satisfaction

Nurses (n=3) rated the use of video consultation on average with a 7.3 (SD .57) on a scale of 1 to 10 (1=not at all satisfied to 10=very satisfied). They were all satisfied with privacy and confidentiality and quality of the sound and video and would recommend its use to colleagues and patients. Two nurses agreed that its use fits in their work process. However, only one nurse was completely satisfied with the information she could provide. They did not think that the use of video consultation helped them save time or work more efficiently.

The nurses reported that use of video consultation is not suitable for new patients, and they prefer to use it during follow-up:

It is not suitable for a first consultation after starting CPAP because you cannot provide enough information.
Not for new patients because providing information and checking the device and sleep mask is difficult using video consultation.

The nurses also experienced some technical problems:

Sometimes there were log-in problems and I had to call the patient first by phone.
Sometimes it took long before there was a connection. This costs more time.

They also provided suggestions for improvement and described advantages of video consultations:

Plan the video consultations one after the other and not alternating with face-to-face consultations.
It is a good alternative for follow-up consultations. It is more patient friendly than a face-to-face consultation.
Saves time for patients.

Principal Findings

In this RCT, we evaluated the superiority of video consultation over face-to-face consultation for newly diagnosed OSA patients. For CPAP use, we found a significant difference in change over time between groups in the short term (P-interaction=.008). However, the specific time points (week 1: P=.62; week 2: P=.15; week 3: P=.33, and week 4: P=.20) were not significantly different. No significant difference in change over time was found for long-term CPAP use (P-interaction=.68). No significant difference in change over time between groups was found for short-term (P-interaction=.17) or long-term (P-interaction=.51) CPAP adherence. Self-efficacy appeared to have a statistically significant effect on CPAP use in both groups (P=.001) regardless of the intervention arm (P=.25). No significant difference between groups was found for outcome expectancies (P=.64), self-efficacy (P=.41), or risk perception (P=.30). The experiences with video consultation were very positive. Almost all patients (60/63, 95%) intended to keep using video consultation. Patients in both groups rated the consultations on average with an 8.4. All nurses (n=3) were satisfied with privacy and confidentiality aspects and quality of the sound and video. However, they expressed some recommendations for improvement (eg, to use video consultation only in follow-up).

Comparison With Prior Work

Unfortunately, change over time was not evaluated in previous controlled studies [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26,Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29], but this evaluation is as such a likely pattern. In our study, a significant difference in CPAP use between video consultation and face-to-face consultation was not found. Parikh et al [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18] reported statistically equivalent CPAP use for new OSA patients (mean average use minutes per day 305.31 vs 340.55, P=.15). In a multicenter RCT, no statistically significant difference was found for CPAP use after 6 months (telemedicine mean use 4.4 [SD 2.0] hours per day vs face-to-face 4.2 [SD 2.0] hours per day, P=.83) and adherence (telemedicine 65% vs usual care 57% compliance, P=.33) [Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29]. Based on these findings, it appears that CPAP use is equivalent to using video consultation.

Where previous studies mainly focused on CPAP use, adherence, and satisfaction with video consultation [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26,Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29], we additionally evaluated the combination of cognitive components (self-efficacy, outcome expectancies, and risk perception), experience with the technology (using the UTAUT model), and satisfaction of patients and nurses. This combination of outcomes has received little attention until now. Cognitive components are found to be increasingly important in predicting CPAP use [Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003 Sep;26(6):727-732. [CrossRef] [Medline]13,Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med 2005 Oct 15;1(4):346-353. [Medline]14,Stepnowsky CJ, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med 2002 May;3(3):239-247. [CrossRef] [Medline]27]. Our results show that use of CPAP is higher in patients with high levels of self-efficacy (P=.001) regardless of the intervention arm (P=.25). In order to improve self-efficacy, it is necessary to positively influence patient perceptions. Patients may benefit from a self-management approach [Stepnowsky CJ, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med 2002 May;3(3):239-247. [CrossRef] [Medline]27,Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli-Israel S. A self-management approach to improving continuous positive airway pressure adherence and outcomes. Behav Sleep Med 2007;5(2):131-146. [CrossRef] [Medline]41,Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns 2002;48(2):177-187. [Medline]42] with tailored education to change their perceptions about CPAP use and subsequently improve self-efficacy [Sawyer AM, Canamucio A, Moriarty H, Weaver TE, Richards KC, Kuna ST. Do cognitive perceptions influence CPAP use? Patient Educ Couns 2011 Oct;85(1):85-91 [FREE Full text] [CrossRef] [Medline]43]. Lai et al [Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest 2014 Sep;146(3):600-610. [CrossRef] [Medline]44] provided patients with additional education to enhance, for example, self-efficacy. This increased CPAP use compared with patients receiving usual care (P<.001). Stepnowsky et al [Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli-Israel S. A self-management approach to improving continuous positive airway pressure adherence and outcomes. Behav Sleep Med 2007;5(2):131-146. [CrossRef] [Medline]41] showed that a self-management program with information about OSA- and CPAP-related issues led to high self-efficacy scores (4.5 [SD 0.6]; scale 0 to 5) and CPAP adherence (5.5 [SD 2.3] mean hours per night). Because self-efficacy scores can be affected by the time that patients are treated, scores should be assessed regularly in order to be useful in clinical practice [Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med 2005 Oct 15;1(4):346-353. [Medline]14].

However, limited evidence was available about the effect of video consultation for newly diagnosed patients starting CPAP. Most previous RCTs were small, with sample sizes varying from 19 to 40 patients [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25]. Only Isetta et al [Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29] evaluated CPAP compliance with a fully powered sample size. Although almost half of the patients (40%) in this study had insufficient digital skills, technology aspects were not evaluated [Isetta V, Negrín MA, Monasterio C, Masa JF, Feu N, Álvarez A, SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax 2015 Nov;70(11):1054-1061. [CrossRef] [Medline]29]. In our study, 9% (20/222) were unable to participate because of lack of access to a mobile device or due to psychiatric or cognitive disorder. During the intervention, 2 patients (2/70, 3%) discontinued the video consultation intervention because of preference for face-to-face consultation or problems with their mobile device. The use of video consultation is evolving rapidly in clinical practice, but digital services are not applicable to all patients and digital health literacy remains a challenge [Smith B, Magnani JW. New technologies, new disparities: the intersection of electronic health and digital health literacy. Int J Cardiol 2019 Oct 01;292:280-282. [CrossRef] [Medline]45]. This is especially due to lack of awareness or knowledge or unwillingness to change [Almathami HKY, Win KT, Vlahu-Gjorgievska E. Barriers and facilitators that influence telemedicine-based, real-time, online consultation at patients' homes: systematic literature review. J Med Internet Res 2020 Feb 20;22(2):e16407 [FREE Full text] [CrossRef] [Medline]46] and emphasizes the importance of personalized interventions rather than a one-size-fits-all approach.

The assessment of UTAUT components and self-efficacy can also be used to indicate technology use [Kohnke A, Cole ML, Bush R. Incorporating UTAUT predictors for understanding home care patients' and clinician's acceptance of healthcare telemedicine equipment. J Technol Manag Innov 2014 Jul;9(2):29-41. [CrossRef]47]. To our knowledge, no previous studies have identified technology acceptance for OSA patients using video consultation. Patients in our study had positive experiences with the use of video consultation and were satisfied with the video consultation system and consultations in general. Previous studies also reported high satisfaction scores [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17,Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18,Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve nonadherence: a placebo-controlled study. Telemed J E Health 2006 Jun;12(3):289-296. [CrossRef] [Medline]25,Coma-Del-Corral MJ, Alonso-Álvarez ML, Allende M, Cordero J, Ordax E, Masa F, et al. Reliability of telemedicine in the diagnosis and treatment of sleep apnea syndrome. Telemed J E Health 2013 Jan;19(1):7-12 [FREE Full text] [CrossRef] [Medline]26], mostly regarding communication with a health care professional [Parikh R, Touvelle MN, Wang H, Zallek SN. Sleep telemedicine: patient satisfaction and treatment adherence. Telemed J E Health 2011 Oct;17(8):609-614. [CrossRef] [Medline]18] and privacy and security factors [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17]. Although most patients would recommend the use of video consultations to others, not all patients in our study are convinced that all visits can be replaced by video consultations. This is in line with findings from previous research [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17].

The involvement of health care professionals is essential to achieve successful implementation of technology [Hennemann S, Beutel ME, Zwerenz R. Ready for eHealth? Health professionals' acceptance and adoption of ehealth interventions in inpatient routine care. J Health Commun 2017 Mar;22(3):274-284. [CrossRef] [Medline]48], but this is often not evaluated [Isetta V, León C, Torres M, Embid C, Roca J, Navajas D, et al. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res 2014 Feb 19;3(1):e6 [FREE Full text] [CrossRef] [Medline]17]. We found that nurses (n=3) preferred to start with a face-to-face consultation because education about the sleep mask and adjustments are often required during the first follow-up appointment with the nurse. The applicability of technology use may be dependent on the population [Johansson AM, Lindberg I, Söderberg S. The views of health-care personnel about video consultation prior to implementation in primary health care in rural areas. Prim Health Care Res Dev 2014 Apr;15(2):170-179 [FREE Full text] [CrossRef] [Medline]49], and for OSA patients, the use of video consultation in a blended care setting might therefore be beneficial. We found that the nurses were satisfied with video consultation and especially with the quality of the system, privacy and confidentiality. They would recommend it to colleagues and patients. Nurses also reported technical problems (eg, problems with Wi-Fi connections). Technological issues are often seen as a barrier [de Veer AJE, Fleuren MAH, Bekkema N, Francke AL. Successful implementation of new technologies in nursing care: a questionnaire survey of nurse-users. BMC Med Inform Decis Mak 2011;11:67 [FREE Full text] [CrossRef] [Medline]50], and it is important to take technical elements into account [Hennemann S, Beutel ME, Zwerenz R. Ready for eHealth? Health professionals' acceptance and adoption of ehealth interventions in inpatient routine care. J Health Commun 2017 Mar;22(3):274-284. [CrossRef] [Medline]48,Scott KC, Karem P, Shifflett K, Vegi L, Ravi K, Brooks M. Evaluating barriers to adopting telemedicine worldwide: a systematic review. J Telemed Telecare 2018 Jan;24(1):4-12 [FREE Full text] [CrossRef] [Medline]51,Gagnon MP, Orruño E, Asua J, Abdeljelil AB, Emparanza J. Using a modified technology acceptance model to evaluate healthcare professionals' adoption of a new telemonitoring system. Telemed J E Health 2012;18(1):54-59 [FREE Full text] [CrossRef] [Medline]52] during implementation. Another point for improvement is integration in existing health care processes (eg, planning). To achieve successful implementation, it can be beneficial to involve professionals during the implementation process itself [de Veer AJE, Fleuren MAH, Bekkema N, Francke AL. Successful implementation of new technologies in nursing care: a questionnaire survey of nurse-users. BMC Med Inform Decis Mak 2011;11:67 [FREE Full text] [CrossRef] [Medline]50].

Video consultation can be seen as a promising app to support OSA patients during treatment. Still, evidence was lacking and previous research was not strong enough in design or focused on a limited number of outcomes. With the evaluation of a broad range of outcomes affecting CPAP use and implementation of video consultation in clinical practice, this RCT adds value to current knowledge.

However, proper evaluation in this field is challenging because research often lags behind the rapid development of technology [Baker TB, Gustafson DH, Shah D. How can research keep up with eHealth? Ten strategies for increasing the timeliness and usefulness of eHealth research. J Med Internet Res 2014;16(2):e36 [FREE Full text] [CrossRef] [Medline]53]. The use of pragmatic trials may be promising [Peterson ED, Harrington RA. Evaluating health technology through pragmatic trials: novel approaches to generate high-quality evidence. JAMA 2018 Jul 10;320(2):137-138. [CrossRef] [Medline]54] to evaluate different elements of eHealth solutions in a hospital setting and can, for example, be used to get (more) rapid insights in relevant implementation outcomes such as feasibility, impact on an organization, and acceptance and adoption by health care professionals and patients. Future research should focus on blended care approaches in which self-efficacy especially receives greater emphasis. For organizations to be able to implement video consultation on a larger scale, integration in existing health care processes and technology acceptance by patients and professionals is necessary.

Limitations

Several limitations should be considered. Risk perception and outcome expectancies were significantly different at baseline, despite randomization. For a limited number of patients (7/66, 11%, in the intervention group and 6/70, 9%, in the control group), video consultations or face-to-face consultations were replaced with a telephonic consultation due to technical problems in the intervention group and because patients in the control group could not come to the hospital. The protocol process were not strictly followed because patients failed to attend their scheduled appointment (no show, sick, on holiday) or there were organizational inaccuracies such as wrongly scheduled appointments. The percentage of patients that followed the process exactly as described (

Multimedia Appendix 1

Study process.

PNG File , 61 KBMultimedia Appendix 1) was higher in the intervention group (approximately half) than in the usual care group (approximately one-third). However, all patients received the intervention (type of consultation) they were allocated to except for the 2 patients who discontinued the intervention (Figure 1). Another limitation is that only 3 nurses were involved in the evaluation. Therefore, a firm conclusion on professional aspects cannot be drawn.

Conclusion

Support of OSA patients with video consultation does not lead to superior results on CPAP use and adherence compared with face-to-face consultation. The findings of this research show that a significant difference in change over time was found between groups for short-term CPAP use (but not on specific time points), but not for long-term CPAP use. Levels of self-efficacy were positively related to CPAP use in both groups. Patients were very satisfied with video consultation and reported positive experiences.

Therefore, the findings of this research suggest that self-efficacy is an important factor in improving CPAP use and that video consultation may be a feasible way to support patients starting CPAP. The integration in health care processes and tailoring video consultation use to patient and professional needs is essential to ensure successful use. A blended care setting, in which an initial video consultation is combined with face-to-face consults, may be beneficial. To our knowledge, this is the first RCT that examined the effects of video consultation on CPAP use over time for newly diagnosed OSA patients in combination with cognitive components and experience with technology use. Future research should focus on blended care approaches in which self-efficacy receives greater emphasis.

Acknowledgments

The authors thank Els Fikkers (nurse practitioner, pulmonology) for her assistance with the study.

Conflicts of Interest

None declared.

Multimedia Appendix 1

Study process.

PNG File , 61 KB

Multimedia Appendix 2

Short-term CPAP use.

DOC File , 30 KB

Multimedia Appendix 3

Short-term CPAP use: change over time.

PNG File , 70 KB

Multimedia Appendix 4

Short-term CPAP adherence.

DOC File , 29 KB

Multimedia Appendix 5

Long-term CPAP adherence.

DOC File , 29 KB

Multimedia Appendix 6

Self-Efficacy Measure for Sleep Apnea constructs: self-efficacy, risk perception, and outcome expectancies.

DOC File , 29 KB

Multimedia Appendix 7

Expectations and experiences with video consultation.

DOC File , 38 KB

Multimedia Appendix 8

Patient satisfaction with consultation.

DOC File , 36 KB

Multimedia Appendix 9

Patient satisfaction with video consultation.

DOC File , 36 KB

Multimedia Appendix 10

CONSORT-eHEALTH checklist (V 1.6.1).

PDF File (Adobe PDF File), 412 KB

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AHI: apnea-hypopnea index
CONSORT: Consolidated Standards of Reporting Trials
CPAP: continuous positive airway pressure
OSA: obstructive sleep apnea
RCT: randomized controlled trial
SEMSA: Self-Efficacy Measure for Sleep Apnea
UTAUT: unified theory of acceptance and use of technology


Edited by G Eysenbach; submitted 28.05.20; peer-reviewed by M Stommel; comments to author 04.07.20; revised version received 25.10.20; accepted 13.04.21; published 11.05.21

Copyright

©Laura Kooij, Petra JE Vos, Antoon Dijkstra, Elisabeth A Roovers, Wim H van Harten. Originally published in JMIR Formative Research (https://formative.jmir.org), 11.05.2021.

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