Design and setting

The present research is a qualitative study using a participatory approach to engage all stakeholders including patients with OSA who used CPAP machines, sleep medicine specialists, sales companies, researchers, and software developers, in different steps of need analysis, design, and evaluation process.

The study was conducted in Mashhad, the second metropolis of Iran. All sleep medicine specialists who participated in this study were faculty members of Mashhad University of Medical Sciences. The patients were selected in two ways: those who had purchased their CPAP device from Resmed or Weinmann companies in Mashhad and those who were referred to the specialists mentioned above to treat sleep apnea and for follow-up purposes.

The present research was conducted in five phases. The first was exploratory and investigated the body of related literature. In the second phase, a need analysis was done with the cooperation of the main stakeholders. The third phase involved data integration. The fourth phase involved content development and the design of a telemonitoring system named Roya. The fifth phase involved the evaluation of the content and system. Figure 1 summarizes this procedure.

Fig. 1
figure 1

Overview of the development and evaluation process

Exploratory phase

The body of related literature on sleep apnea treatment and a focus on patient’s adherence to CPAP belonged to either of the following two categories:

Exploring effective factors on adherence to CPAP

In the body of related literature, among the effective factors of adherence to CPAP were patients’ characteristics, the severity of disease, side effects of using the device, method of conducting the sleep test and titration, claustrophobia, inadequate support of the clinical team, lacking cooperation of the spouse, inadequate knowledge and high costs of treatment and equipment. These were among the main barriers to adherence to treatment [7, 14,15,16,17,18]. Among the facilitators of adherence to CPAP were: the willingness to rid of symptoms and a positive attitude to treatment, awareness of the adverse effects of the disease, fear of the social consequences, disrupting others’ sleep, trust in healthcare providers, spouse’s cooperation, feeling physically improved, use of a humidifier, changing the design of the device, benefiting of social, clinical and behavioral change supports [7, 14,15,16,17,18].

Exploring interventions for adherence to CPAP

According to a review by Askland et al. (2020) published by Cochrane [19], interventions in the literature can be divided into three types, educational, supportive and behavioral.

Educational interventions These interventions provide general information about OSA and CPAP therapy through different techniques including educational videos, group sessions, personalized explanation of polysomnography (PSG) reports, and positive/negative risk message framing [20,21,22,23]. Although educating patients is the primary way of involving them in the therapeutic process, it has a minor effect on CPAP adherence as a complicated behavior [18]. So, it is suggested the educational interventions be accompanied by other interventions.

Supportive interventions These interventions provide participants with further clinical follow-up by the clinical staff through telemonitoring to remove barriers or difficulties in using CPAP. The principal privilege of this type of intervention is that patients are encouraged to provide regular feedback on the experience of using the device. Therefore, the therapeutic barriers and problems are removed at the right time. Telemonitoring services in different formats and platforms, such as peer support, web-based, and personalized programs are among supportive interventions [24,25,26,27,28,29,30].

Behavioral interventions These include interventions with psychotherapeutic techniques based on behavioral, cognitive, or models related to health behavior change. Behavioral interventions addressed modifiable and measurable constructs that influenced the health beliefs about OSA and CPAP therapy and adherence to CPAP behavior. In different studies, various motivational strategies such as Motivational Enhancement Therapy (MET), Socio-Cognitive Theory (SCT), and habit formation audiotapes [31,32,33,34] were mixed with educational and supportive materials to enhance effectiveness [35,36,37,38,39].

Need analysis

In the second phase, a need analysis was done with the cooperation of the main stakeholders. The purpose was to gain an in-depth understanding of the services needed by patients. So, after each meeting, the key concepts were extracted and presented at the next session to explore more.

Meeting with sleep medicine specialists

To better understand the requirements to provide telemedicine services for OSA patients who use CPAP, different meetings were held with a panel of sleep medicine specialists (n = 4) and medical informatics specialists (n = 2). In these meetings, patients’ needs and current follow-up plans by physicians and selling companies were investigated.

Meeting with key figures of the device selling companies

These meetings were independently held with the key figures of the Resmed (n = 4) and Weinmann (n = 2) companies. In these meetings, services provided to patients such as follow-up plans and instructional materials, and technical capabilities and limitations of devices were discussed.

Interview with patients

To know the needs of patients who use CPAP, semi-structured in-depth interviews were held with 29 patients who did not adhere to the treatment. The detail is described in our previous paper [7].

Data integration

According to the literature review, multiple meetings with sleep specialists and key figures of the device selling companies, and patients’ interviews, the following topics were extracted:

  1. 1.

    Use of different architectures for the telemonitoring system in other countries and further investigations to design and implement the new system in Iran considering the existing technical limitations,

  2. 2.

    Physicians’ concerns about the independence of the device selling companies in the patients’ follow-up and the lack of continuous communication with healthcare providers,

  3. 3.

    Companies’ emphasis and willingness to involve the clinical team in patient follow-up and provision of clinical support,

  4. 4.

    Technical issues such as the absence of a data sending option in CPAP device in a wireless mode to the central system,

  5. 5.

    Barriers to CPAP adherence such as patients’ inadequate knowledge and patients problems in using CPAP device,

  6. 6.

    Use of a combination of different interventions (educational, supportive, and behavioral) to increase effectiveness,

  7. 7.

    Apply behavior change theories and techniques to influence the health beliefs about OSA and CPAP therapy and adherence to CPAP behavior.

System and content development

System architecture

Based on topics 1, 2, 3, and 4, the required parts for designing the telemonitoring system were recognized. This system had to be designed in a way to communicate with different groups (e.g., doctors as the clinical service providers, the device selling companies as the technical service providers, and patients as the service recipients). Also, certain facilities had to be provided for patients to send the CPAP data. Thus, three main parts were proposed including the patient’s application, the doctor’s portal, and the operator’s portal (selling company’s portal) along with facilitating software for patients to send the CPAP data.

Topics 5, 6, and 7 led us to provide clinical, educational, and behavioral supports for patients, simultaneously.

  • Clinical support involves medical support by doctors such as advice on mask replacement, change of pressure, the answers to medical queries, and other instances of medical support.

  • Educational support refers to information provided to raise patients’ awareness of apnea and CPAP therapy.

  • Behavior change support refers to measures taken specifically to change a patient’s way of thinking or acting based on a behavior change model or theory to increase the rate of using CPAP eventually.

Clinical support was provided by monitoring patients’ status and sending appropriate feedback and recommendations through the doctor’s portal. Also, to provide education and behavioral support, the applicable content was made available through the patient’s application. It is noteworthy that some of the information displayed on the doctor’s portal and the patient’s application was fed by data in the operator’s portal. The details are described in the result section.

Content development and evaluation

To provide content for the patient’s application, considering the extracted topics and previous findings [40,41,42,43], the socio-cognitive theory (SCT) was selected as the basis of content development, which has four constituent constructs: knowledge, perceived risk, outcome expectancy, and self-efficacy.

Perceived risk has to do with the patient’s perceived susceptibility to health threats. In other words, perceiving that untreated OSA is followed by adverse effects. Outcome expectancy refers to the potential outcomes of using or not using CPAP and the possible impact of using CPAP on reducing the associated risks. Self-efficacy implies one’s perceived capability of showing a particular behavior. In other words, it involves perceiving oneself as capable of using the CPAP device regularly under any condition.

Considering socio-cognitive theory and behavior change techniques [54, 55], sleep apnea-related (the definition, symptoms, risk factors, and negative consequences of sleep apnea) and CPAP-related content (benefits and the probable side effects of using CPAP, equipment description, cleaning and replacement methods, troubleshooting, and how to travel with CPAP) were taken as the major portion of the content. This content was derived from credible global websites, existing publications, and sleep specialists’ opinions. Table 1 shows the relationship between the behavior change techniques and the prepared content.

Table 1 Behavior change techniques, definition, and content of the application

The accuracy, comprehensibility, clarity, and simplicity of the content were assessed by four sleep medicine specialists in a focus group and finalized. Also, a sample of target patients evaluated the difficulty of phrases to decrease the cases of ambiguity and erroneous inferences made of the utterances or the meanings. If a problem was found, the content was changed as required.

System evaluation

Usability testing of patient’s application

To test the usability of the patient’s application, a think-aloud protocol was used, which is a user-based and empirical method based on the observation of system performance in time [44]. The think-aloud method collects data about users’ cognitive growth in working with the system. In this method, users are asked to state out loud whatever they see, think about, and feel, as well as the questions that arise in their minds or their decisions.

For this purpose, seven patients who used CPAP were selected. Two trained facilitators and a software engineer were also present during the evaluation process. The evaluation process was followed in a room of a sleep test clinic within a peaceful and light environment. To conduct the evaluation process, a scenario was developed based on the tasks and duties of the Roya telemonitoring system. All users’ interaction with the system and their voices were recorded by a screen recorder on a tablet computer and a microphone. When the evaluations were completed, all the recorded documents were analyzed by the facilitators. To categorize problems, the method suggested by Haak et al. was used, according to which the problems were categorized into four groups, including system layout, terminology, data entry, and comprehensiveness.

The detail of the usability evaluation process is provided in Appendix 1A.

Functionality testing of patient’s application:

In this phase, the primary purpose of functionality testing was to check the success of:

  • installing the application on smartphones, each with a different version of the Android operating system,

  • transferring the CPAP data from the operator’s portal to the patient’s application,

  • transferring responses to daily questions and user problems from the application to the doctor’s portal,

  • displaying charts and content in different mobile sets,

  • showing videos integrated within the content in different mobile sets,

  • the functionality of settings in different mobile sets,

For this purpose, ten patients who had purchased their CPAP devices from two sales companies in Mashhad, were literate, and had smartphones to work with effectively were selected. They used the application for two weeks. Patients’ comments and issues they faced while using the application were recorded in the form of unstructured interviews. They were then provided to the technical team after more scrutiny for further development of the system. The detail of the functionality evaluation process is provided in Appendix 1B.

Evaluation of doctor’s portal and selling companies’ portal

As the system development was done via the agile, recursive, and incremental method, during the project development process, different versions of the doctor’s portal and the selling companies’ portal were continuously made available to doctors and sales companies. After the evaluation, their comments were obtained through unstructured interviews and applied as far as possible by the technical team. This process continued until the end of the system design and final approval by the users of the two portals.

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