We conducted a qualitative interview study on the perspectives of patient-users of an mHealth app for hypertension care. This study is part of the digital preventive measures for arterial hypertension (DiPaH) - project [11], which examines the structural and individual factors of patients and stakeholders in the use of digital preventive measures in patients with arterial hypertension in Germany.

The app (Hypertension.APP) which patient-users were interviewed in this study was selected as an example according to expert recommendations (Prof Dr Martin Middeke and Prof Dr med Miklós Illyés). The Hypertension.APP is developed and maintained by the Hypertension Care UG (Ingolstadt) [12]. The application has been downloaded in app stores nearly 10,000 times as of May 2024. It includes a diary function to document blood pressure data, a personalized guide that provides information based on the user’s health profile, an export function to generate reports for medical consultation, a reminder function, and interactive exercises. The Hypertension.APP and its functions are shown in Figure 1 [12]. The app is freely accessible in various app stores. There is also a purchasable premium version which includes additional features.

Patient-users were invited to participate in the study through the Hypertension.APP. A study invitation for the DiPaH study was placed in the app which led users to an online questionnaire survey and an online form for entering contact details for the interviews. The study team contacted people who had entered their contact details within 14 days and an interview appointment was arranged. Participants were selected using purposive sampling with the aim to include heterogeneous app users [13]. The inclusion criteria were age 18 years or more, use of the app in the last 2 years, and arterial hypertension. A further inclusion criterion was interest in and willingness to participate in the interviews. We chose to conduct 20 interviews as this number has proven to be adequate in previous studies to reach theoretical saturation in the exploration of digital approaches [14-16].

A preliminary semistructured interview guide was drafted by a multiprofessional team (FM, SM, EW, DB, and SS). The semistructured interview guide consisted of open-ended questions that explored participants’ motifs to use the Hypertension.APP, its usability, and the advantages and disadvantages of the app, as well as its impact on personal hypertension care. Sample interview questions included: (1) “Please remember. How did you come to use this app?” (2) “Please tell me, what do you think of the app?” (3) “What role does the app play in your hypertension care?” In addition, sociodemographics and health-related data were collected, including profession, sex, age, location (rural or urban), federal state, education, technical devices, blood pressure values, antihypertensive drugs, time since diagnosis, comorbidities, and tobacco use. To test the applicability of this guide, we conducted 3 pilot interviews (1 to 3). The interview guide (Multimedia Appendix 1) proved to be appropriate, so the 3 pilot interviews were included in the analysis. All interviews were conducted by an experienced qualitative researcher (FM) by telephone, between January and June 2023. The interviews were recorded and transcribed. Data collection was continued until the aim of 20 interviews was achieved. Consistent with the planned number of interviews, no substantial new findings emerged, and saturation of content was reached [17].

Data were analyzed in parallel with the data collection by 2 experienced qualitative researchers (FM and SM). Analysis was based on Kuckartz’s structured qualitative content analysis [18] using MAXQDA Analytics Pro 2022 (version 22.1.0; Verbi GmbH). After transcription of the audio material, the analysis began with the screening of the interview texts, whereupon the interviews were coded. Relevant text passages from the interview materials were coded according to a deductive-inductive procedure. The main categories were developed deductively based on the research questions of the DiPaH study and subcategories were formed inductively from the codes. Consensus discussions were held continuously in the research group until a common understanding of all the emerging categories was achieved. After data collection was concluded, the 2 researchers (FM and SM) separately applied the established category system to analyze the complete dataset, ensuring that the process could be traced and replicated. For the presentation of the results, representative quotes from the transcripts were selected, translated into English, and included into the manuscript.

The study was approved by the ethics committee of the Brandenburg Medical School Theodor Fontane (E-02-20220620). The study was registered as part of the DiPaH project at German Clinical Trials Register (DRKS00029761). Primary data collection was conducted in compliance with the current data protection regulations of the General Data Protection Regulation and the Helsinki declaration. Participants received extensive study information and provided written informed consent. Data were pseudonymized before analysis. No conclusions can be drawn about individuals in the presentation of results. Participants received €30.00 (US $33.07) as an incentive and compensation for their participation. Patients were not involved in designing this study. The manuscript has been compiled in accordance with the COREQ (Consolidated Criteria for Reporting Qualitative Research; Multimedia Appendix 2) [19]. All methods were performed in accordance with relevant guidelines and regulations.

A total of 20 interviews with 20 participants were conducted and were included in the analysis. The mean duration of the interviews was 26 (10-40) minutes. The mean age of the participants was 56 (range 29-80) years. In total, 10 females and 10 males were interviewed. Out of 20, 13 participants were located in an urban area (>20,000 inhabitants), whereas 7 were located in a rural area (<20,000 inhabitants). The systolic blood pressure level most frequently reported was 130-139 mm Hg and diastolic blood pressure was <80 mm Hg. Most of the participants (16/20) were on blood pressure-lowering medication. Half of the participants were diagnosed with hypertension 1-5 years ago. None of the participants were currently using tobacco, while 7 had used tobacco earlier. All participants of this study used the free version of the app. Table 1 shows further information on participant characteristics.

A total of 4 key themes were explored in the analysis: (1) access to mHealth apps in hypertension care, (2) expected benefits of using mHealth apps in hypertension care, (3) potential risks of using apps in hypertension care, and (4) role of the app in hypertension care routines. Table 2 contains the details of the final coding tree.

The participants reported that the diagnosis of high blood pressure was the initial reason for using the app:

The participants recounted that they had discovered the app mostly on their own. They either searched directly for an app on hypertension in the app store or they searched for further information on hypertension and then became aware of the app through relevant websites.

The participants recalled their dissatisfaction with the information provided by their treating HCPs concerning effective self-management strategies for blood pressure and undertook their own research endeavors. They independently searched for information on their condition to positively influence it through lifestyle changes. In doing so, they differentiated reliable sources from others.

The patients experienced no problems in downloading or installing the app. Overall, the methods by which the participants accessed the app demonstrated high levels of self-efficacy which was also reflected in the expected benefits of using the app.

The main motivation for using the app was the desire to save and continuously monitor blood pressure values on a long-term basis and to provide a clear overview to organize one’s own lifestyle and make adjustments to it. This was in contrast to the selective blood pressure recording during doctor visits.

From the participants’ perspective, one advantage of documentation through the app over other types of documentation is that patient-users receive immediate explanations and feedback on their values.

The app users relate this feedback directly to their lifestyle and adapt it if necessary. The app provides a basis for decisions regarding behavioral changes.

Compared with analog and paper-based documentation types, the overview and convenience of documentation through the app were emphasized by the participants.

The participants emphasized the importance of managing their illnesses independently. They reported that the app effectively helped them achieve this objective, particularly by controlling their blood pressure.

One app user also reported that the app enabled him to lead an independent life and that independent app-supported monitoring helped him visit the doctor less often.

In addition to the perceived benefits, participants were also asked about potential risks of using the app. However, most participants did not perceive any risk when using the app. Some participants addressed the general risk of misuse of data by third parties:

Furthermore, the participants reported a risk of excessive use of the app.

In the interviews, the participants described the app as an essential element in the self-management of their own hypertension care routines. In contrast to conventional hypertension care, continuous availability of support and information was emphasized in the interviews. In some cases, the app was even personified and its use was described as a treatment.

The app provides information to understand one’s condition. Participants described that the app supports communication with the medical staff and enables patient-users to express their needs.

In addition, the interview participants reported that they had confidence in the app and regarded the information presented as reliable. Simultaneously, the significance that the user attaches to the app’s information is not acknowledged in the doctor’s office.

Similarly, another user suggested that the treating doctor might feel intimidated by the app or the information provided. The app is currently not integrated into the user’s medical hypertension care.

This qualitative study is the first to explore user experiences with an mHealth app in hypertension care, focusing on app accessibility, expected benefits, potential risks, and its role in hypertension care in Germany. The study showed that patient-users of the Hypertension.APP typically discovered the app independently, driven by a combination of a recent high blood pressure diagnosis and a lack of satisfactory information from their HCP. These patient-users particularly appreciated the app’s capabilities for continuous monitoring and documentation of blood pressure, as it offered valuable feedback and explanations, aiding them in understanding their condition and making informed lifestyle adjustments. While acknowledging these benefits, patient-users also noted potential risks concerning data privacy and the possibility of becoming overly reliant on the app, although they assigned relatively low importance to these concerns. The app has become an essential part of users’ disease management routines, providing consistent support and information that contrasts with low-frequency traditional doctor visits. Regarding the disappointment of app users, the integration of the app into formal health care settings was limited, with some patient-users sensing a lack of acceptance or even intimidation from the HCP toward the technology.

Our results clearly indicate that mHealth can be a valuable tool for self-management of arterial hypertension. This finding is in concordance with existing research, underscoring the substantial potential and effectiveness of digital health [5,6], particularly mHealth [7], not only in hypertension care but also in other medical areas [14-16].

While in other medical domains the use of digital technologies is associated with depersonalization or dehumanization of health care [14,20], in this study, participants personified the app or considered it a “sparring partner.” We hypothesize that providing personalized information enhances user motivation and commitment to app usage, and therefore recommend this for the development of digital health applications.

From a socio-technological perspective, our findings resonate with Bruno Latour's actor-network theory [21]. This theory characterizes an “actant” as an entity that either acts or is granted action by others, without necessarily attributing specific motivations to human actors or humans in general. In this framework, any entity can be an actant as long as it is acknowledged as the origin of an action. In the realm of hypertension management, our data position the app as a pivotal actant within the actor network. Remarkably, for some patient-users, the app assumed a more influential role than that of the health care professionals involved, underscoring its significance in this domain.

Notably, the participants expressed dissatisfaction with the lack of integration of mHealth into standard hypertension care. They advocated its inclusion in formal hypertension practices, stressing the need for HCPs to recognize and leverage these digital health tools. Why do German HCPs have reservations about mHealth in hypertension care? The reluctance of German HCPs toward mHealth in hypertension management is a multifaceted issue, as explored in a separate module of the DiPaH study [11]. HCPs reported doubts regarding the validity of patient-generated data, data privacy concerns, and additional efforts including training and interoperability. These factors, along with the absence of incentives and insufficient incorporation into the health care system’s reimbursement frameworks, are major hindrances to the full exploitation of mHealth capabilities, despite the advantages acknowledged by patients. This contrasts with other chronic conditions, such as rheumatoid arthritis, where HCPs acknowledge the value of mHealth in facilitating shared decision-making and adopting a treat-to-target approach [15].

It appears critical that patient-users of mHealth applications, especially those managing chronic diseases, receive serious attention and support from their HCPs. Therefore, potential users and stakeholders should be involved in the development of digital health applications. This was the case for the development of Hypertension.APP. However, there is currently a significant shortfall in the information resources available to HCPs which is crucial as there is evidence that HCPs’ knowledge of telemedicine is closely intertwined with their actual use of telemedicine services [22]. Low-threshold training opportunities for HCP are highly needed and should be supported by professional organizations involved in hypertension care.

Looking ahead, the narratives from our interview participants suggest that they possessed a high level of self-efficacy and eHealth literacy, as well as a higher income and educational background. This observation raises critical questions about accessibility and equity: who is able to use these mHealth services effectively, and who is not? Based on interviews alone, we can only speculate; however, a more comprehensive analysis combining interview and questionnaire data would offer valuable insight into these dynamics. It could provide a clearer picture of the demographic profile of current patient-users of mHealth in hypertension care, and potentially identify groups that are currently underserved or unable to benefit from this digital health technology.

This knowledge would be instrumental in developing strategies to make mHealth more accessible and effective for a broader range of patients, particularly those with chronic conditions, such as hypertension.

While our study offers valuable insights, it is essential to acknowledge its limitations. First, the inclusion of solely patient-users, particularly limited to one specific app may introduce selection bias, potentially limiting the generalizability of our findings. In addition, the perspectives of treating HCP, particularly GPs and cardiologists, warrant exploration in a separate study to provide a comprehensive understanding of hypertension management. Specifically, investigating the optimal integration of app data into the local electronic medical record and the workflow for HCPs is imperative, as this aspect could significantly influence their acceptance of digital hypertension care.

In addition, our study may be susceptible to self-selection bias and social desirability bias, exacerbated by the provision of study incentives. Furthermore, the demographic composition of interview participants, predominantly consisting of highly educated nonsmokers, fails to fully represent the diverse population living with hypertension. The absence of reported issues during the download and installation of the app suggests that our sample might also possess higher levels of self-efficacy, eHealth literacy, and technical skills compared with the general population. This indicates a potential overestimation of these attributes in the broader community of hypertensive patients. Most participants had controlled blood pressure levels, with only a minority having systolic blood pressure >139 mm Hg and some not on medication. This may also have influenced the HCPs perceived need for mHealth based blood pressure monitoring.

Furthermore, it is crucial to acknowledge that the app used in our study lacks certification as a digital therapeutic (“Digitale Gesundheitsanwendung” or DiGA), limiting its integration into standard health care systems and reimbursement schemes.

However, despite these limitations, our study stands as the first exploration of user experiences with an mHealth app for hypertension care in Germany. By closely examining the realities of care and patient perspectives, our findings offer valuable insights into the potential of digital self-management in hypertension care and highlight areas where further improvement is needed.

Among the sample studied, mHealth apps like Hypertension.APP were highly valued for their continuous monitoring and educational content, which aids in hypertension management. The findings highlight the potential of mHealth apps for effective hypertension care among patients who are health- and digitally-literate, as well as self-effective. However, there is a critical need for better integration of these apps into routine health care practices, as perceived by the users. This includes addressing the skepticism and lack of acceptance among HCP, ensuring that they receive the necessary training and resources to effectively use these tools. Further research should also focus on the accessibility and effectiveness of mHealth apps across diverse patient populations to promote equitable health benefits.