JMIR Publications

JMIR Formative Research

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Journal Description

JMIR Formative Research (JFR) (a sister journal of J Med Internet Res (JMIR) and JMIR mHealth & uHealth, the leading eHealth and mHealth journals by impact factor) publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research. While the original focus was on the design of medical and health-related research and technology innovations, JFR publishes studies from all areas of medical and health research.

Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help

  • define and understand populations in need of a intervention or public health program
  • create programs that are specific to the needs of those populations
  • ensure programs are acceptable and feasible to user before launching
  • improve the relationship between users and agencies/research groups
  • demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at heatlh outcomes)

Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).

Formative research should be an integral part of developing programs or adapting programs, and should be used while the program is on-going to help refine and improve program activities. Thus, formative evaluation can and should also occur in form of a process evaluation alongside a summative evaluation such as a RCT.

 

Recent Articles:

  • Virtual pill box of the Medisafe app (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://formative.jmir.org/2017/1/e5/; License: Creative Commons Attribution (CC-BY).

    Implications for Training on Smartphone Medication Reminder App Use by Adults With Chronic Conditions: Pilot Study Applying the Technology Acceptance Model

    Abstract:

    Background: The majority of middle-aged to older patients with chronic conditions report forgetting to take medications as prescribed. The promotion of patients’ smartphone medication reminder app (SMRA) use shows promise as a feasible and cost-effective way to support their medication adherence. Providing training on SMRA use, guided by the technology acceptance model (TAM), could be a promising intervention to promote patients’ app use. Objective: The aim of this pilot study was to (1) assess the feasibility of an SMRA training session designed to increase patients’ intention to use the app through targeting perceived usefulness of app, perceived ease of app use, and positive subjective norm regarding app use and (2) understand the ways to improve the design and implementation of the training session in a hospital setting. Methods: A two-group design was employed. A total of 11 patients older than 40 years (median=58, SD=9.55) and taking 3 or more prescribed medications took part in the study on one of two different dates as participants in either the training group (n=5) or nontraining group (n=6). The training group received an approximately 2-hour intervention training session designed to target TAM variables regarding one popular SMRA, the Medisafe app. The nontraining group received an approximately 2-hour control training session where the participants individually explored Medisafe app features. Each training session was concluded with a one-time survey and a one-time focus group. Results: Mann-Whitney U tests revealed that the level of perceived ease of use (P=.13) and the level of intention to use an SMRA (P=.33) were higher in the training group (median=7.00, median=6.67, respectively) than in the nontraining group (median=6.25, median=5.83). However, the level of perceived usefulness (U=4.50, Z=−1.99, P=.05) and the level of positive subjective norm (P=.25) were lower in the training group (median=6.50, median=4.29) than in the nontraining group (median=6.92, median=4.50). Focus groups revealed the following participants’ perceptions of SMRA use in the real-world setting that the intervention training session would need to emphasize in targeting perceived usefulness and positive subjective norm: (1) the participants would find an SMRA to be useful if they thought the app could help address specific struggles in medication adherence in their lives and (2) the participants think that their family members (or health care providers) might view positively the participants’ SMRA use in primary care settings (or during routine medical checkups). Conclusions: Intervention training session, guided by TAM, appeared feasible in targeting patients’ perceived ease of use and, thereby, increasing intention to use an SMRA. Emphasizing the real-world utility of SMRA, the training session could better target patients’ perceived usefulness and positive subjective norm that are also important in increasing their intention to use the app.

  • Source: Flickr; Copyright: Bread for the World; URL: https://flic.kr/p/duZSk9; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Using mHealth to Support Postabortion Contraceptive Use: Results From a Feasibility Study in Urban Bangladesh

    Abstract:

    Background: As access to mobile technology improves in low- and middle-income countries, it becomes easier to provide information about sensitive issues, such as contraception and abortion. In Bangladesh, 97% of the population has access to a mobile signal, and the equity gap is closing in mobile phone ownership. Bangladesh has a high pregnancy termination rate and improving effective use of contraception after abortion is essential to reducing subsequent unwanted pregnancies. Objective: This study examines the feasibility and acceptability of implementing a short message service (SMS) text message-based mHealth intervention to support postabortion contraceptive use among abortion clients in Bangladesh, including women’s interest in the intervention, intervention preferences, and privacy concerns. Methods: This feasibility study was conducted in four urban, high abortion caseload facilities. Women enrolled in the study were randomized into an intervention (n=60) or control group (n=60) using block randomization. Women completed a baseline interview on the day of their abortion procedure and a follow-up interview 4 months later (retention rate: 89.1%, 107/120). Women in the intervention group received text message reminders to use their selected postabortion contraceptive methods and reminders to contact the facility if they had problems or concerns with their method. Women who did not select a method received weekly messages that they could visit the clinic if they would like to start a method. Women in the control group did not receive any messages. Results: Almost all women in the feasibility study reported using their mobile phones at least once per day (98.3%, 118/120) and 77.5% (93/120) used their phones for text messaging. In the intervention group, 87% (48/55) of women were using modern contraception at the 4-month follow-up, whereas 90% (47/52) were using contraception in the control group (P=.61). The intervention was not effective in increasing modern contraceptive use at follow-up, but 93% (51/55) of women reported at follow-up that the text reminders helped them use their method correctly and 76% (42/55) said they would sign up for this service again. Approximately half of the participants (53%, 29/55) said that someone they did not want to know about the text message reminders found out, mostly their husbands or children. Conclusions: In this small-scale feasibility study, text reminders did not increase postabortion contraceptive use. Despite the ineffectiveness of the text reminder intervention, implementation of a mHealth intervention among abortion clients in urban Bangladesh was feasible in that women were interested in receiving follow-up messages after their abortion and mobile phone use was common. Text messages may not be the best modality for a mHealth intervention due to relatively low baseline SMS text message use and privacy concerns.

  • Nonparticipation in videoconferencing-based alcohol treatment. Source: Image created by the Authors and Colleagues; Copyright: The Authors; URL: http://formative.jmir.org/2017/1/e3/; License: Creative Commons Attribution (CC-BY).

    Videoconferencing-Based Treatment of Alcohol Use Disorders: Analyses of Nonparticipation

    Abstract:

    Background: We recently conducted a small randomized controlled trial (RCT) aiming to examine the effectiveness of videoconferencing-based treatment of alcohol use disorders in a real-life setting. The patient and participation rates were lower than anticipated. Objective: The objectives of our study were (1) to examine differences between participants and nonparticipants, and (2) to examine the characteristics of nonparticipants and their reported reasons for not participating. Methods: First, we analyzed nonparticipation through a comparative analysis of participants and nonparticipants using data from a clinical database, covering all patients starting treatment at the clinic. Second, on the basis of data from an anonymous questionnaire filled out by nonparticipants, we analyzed barriers to participating and the descriptive sociodemographics of nonparticipants who reported technical barriers versus those who did not. Results: Of 128 consecutive patients starting treatment during the study period, we found no significant differences between participants (n=71) and nonparticipants (n=51) according to sociodemographics, alcohol measures, and composite scores. Of 51 nonparticipants, 43 filled out the questionnaire with reasons for not participating. We derived 2 categories of barriers from the questionnaire: scientific barriers, which were barriers to the scientific study in general (n=6), and technical barriers, which were barriers to using a laptop or videoconferencing specifically (n=27). We found no significant differences in sociodemographics between nonparticipants who reported technical barriers to participating in the study and those who did not note technical barriers. A total of 13 patients elaborated on technical barriers, and 9 patients found videoconferencing impersonal, preferred personal contact, and would rather attend face-to-face treatment at the clinic. Conclusions: Patient barriers to participating in the RCT were mainly concerned with the technology. There were no significant differences between participants and nonparticipants, nor between nonparticipants who noted technical barriers to participating and those who did not. If a similar study is to be conducted or the solution is to be upscaled and implemented, attention should be given to the user friendliness of the technical equipment and the recruitment process, preparing the patients by emphasizing the information given to them about the technical equipment and its advantages.

  • Patient data flow between provider and patient in Epharmix system. Source: Figure 1 from http://formative.jmir.org/2017/1/e2; Copyright: the authors; License: Creative Commons Attribution (CC-BY).

    A Novel Patient Engagement Platform Using Accessible Text Messages and Calls (Epharmix): Feasibility Study

    Abstract:

    Background: Patient noncompliance with therapy, treatments, and appointments represents a significant barrier to improving health care delivery and reducing the cost of care. One method to improve therapeutic adherence is to improve feedback loops in getting clinically acute events and issues to the relevant clinical providers as necessary (ranging from detecting hypoglycemic events for patients with diabetes to notifying the provider when patients are out of medications). Patients often don’t know which information should prompt a call to their physician and proactive checks by the clinics themselves can be very resource intensive. We hypothesized that a two-way SMS system combined with a platform web service for providers would enable both high patient engagement but also the ability to detect relevant clinical alerts. Objective: The objectives of this study are to develop a feasible two-way automated SMS/phone call + web service platform for patient-provider communication, and then study the feasibility and acceptability of the Epharmix platform. First, we report utilization rates over the course of the first 18 months of operation including total identified clinically significant events, and second, review results of patient user-satisfaction surveys for interventions for patients with diabetes, COPD, congestive heart failure, hypertension, surgical site infections, and breastfeeding difficulties. Methods: To test this question, we developed a web service + SMS/phone infrastructure (“Epharmix”). Utilization results were measured based on the total number of text messages or calls sent and received, with percentage engagement defined as a patient responding to a text message at least once in a given week, including the number of clinically significant alerts generated. User satisfaction surveys were sent once per month over the 18 months to measure satisfaction with the system, frequency and degree of communication. Descriptive statistics were used to describe the above information. Results: In total, 28,386 text messages and 24,017 calls were sent to 929 patients over 9 months. Patients responded to 80% to 90% of messages allowing the system to detect 1164 clinically significant events. Patients reported increased satisfaction and communication with their provider. Epharmix increased the number of patient-provider interactions to over 10 on average in any given month for patients with diabetes, COPD, congestive heart failure, hypertension, surgical site infections, and breastfeeding difficulties. Conclusions: Engaging high-risk patients remains a difficult process that may be improved through novel, digital health interventions. The Epharmix platform enables increased patient engagement with very low risk to improve clinical outcomes. We demonstrated that engagement among high-risk populations is possible when health care comes conveniently to where they are.

  • Woman using the COPD self-management application. Source: The Authors; Copyright: Viola Voncken-Brewster; URL: http://formative.jmir.org/2017/2/e1/; License: Creative Commons Attribution (CC-BY).

    The Impact of Participant Characteristics on Use and Satisfaction of a Web-Based Computer-Tailored Chronic Obstructive Pulmonary Disease Self-Management...

    Abstract:

    Background: A randomized controlled trial (RCT) showed that a Web-based computer-tailored self-management intervention for people with or at risk for chronic obstructive pulmonary disease (COPD) did not have a significant treatment effect. Process evaluation measures such as application use and satisfaction with the intervention can help understand these results. Objectives: The aim of this paper is to uncover reasons for suboptimal application use, evaluate satisfaction with the intervention, and investigate which participant characteristics predict application use and user satisfaction. Methods: Participants were recruited through 2 different channels: an online panel and general practice. The intervention group received the intervention, which consisted of 2 modules (smoking cessation and physical activity). The control group received no intervention. The study employed a mixed methods design. Quantitative and qualitative data were gathered assessing participant characteristics, application use, reasons for not using the application, and satisfaction with the intervention. Results: The RCT included 1325 participants. The proportion of individuals who participated was significantly higher in the online group (4072/6844, 59.5%) compared to the general practice group (43/335, 12.8%) (P<.001). Application use was low. Of all participants in the intervention group, 52.9% (348/658) initiated use of one or both modules, 36.0% (237/658) completed an intervention component (prolonged use), and 16.6% (109/658) revisited one of the modules after completing an intervention component (sustained use). Older age, established diagnosis of COPD, or experiencing breathlessness predicted sustained use. Participant satisfaction with the 2 modules was 6.7 (SD 1.6) on a scale from 0 to 10. The interviews revealed that a computer application was believed not to be sufficient and the help of a health care professional was necessary. Participants with a greater intention to change were more satisfied with the application. Conclusions: The application was not used sufficiently. Study materials should be further tailored to younger individuals, those at risk for COPD, and those who do not experience breathlessness in order to increase sustained use among them. Involvement of a health care professional could improve satisfaction with the intervention and potentially increase engagement with the intervention materials. However, to make this possible, recruitment in general practice needs to be improved. Recommendations are made for improving the study design, strengthening the intervention (eg, practice facilitation), and linking the computer application to interaction with a health care provider.

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