Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn disease, is a chronic, relapsing condition with symptoms such as abdominal pain, diarrhea, and bloody stools [1,2]. These symptoms can impact psychological and social well-being, lowering quality of life [3]. Most patients undergo lifelong treatment and check-ups, with flare-ups often requiring prompt treatment [4,5]. Patients must prioritize self-management, including easy access to health care professionals who may help alleviate living with IBD [3,6,7]. Access to support from health care professionals often takes place by telephone or email [8]. However, patients may experience difficulties in gaining access [3,9,10]. Close communication with health care professionals is essential for supporting patients’ self-management, well-being, and quality of life [6,11]. In addition, handling symptoms consists of adapting diet, medical treatment, stress management, and symptom recognition [6]. Thus, there is a need to improve access to health care professionals and increase self-management among patients with IBD.

eHealth, as defined by World Health Organization [12], involves using information and communication technologies in health care and has become an essential part of modern health care, particularly in the management of chronic conditions such as IBD [13,14]. eHealth is a favored solution among patients with IBD and can potentially improve access to health care professionals [10]. eHealth enables remote self-management [15,16], including symptom monitoring and shared decisions, and has a positive impact on quality of life [16-18]. Mobile health (mHealth) apps are becoming popular, as they contribute to direct care, treatment support, and psychosocial support [10,19,20]. mHealth is defined by the World Health Organization as use of mobile wireless technologies for public health [12]. mHealth can support patients with flexible, timely, and ongoing communication with health care professionals, including symptom management, which helps reduce psychological stress [15,21]. However, most IBD apps focus primarily on symptom tracking and accessing information [22].

Previous studies highlighted the importance of involving patients with IBD in designing eHealth technologies to identify tools and functionalities that the patients find relevant and effective [10,23]. However, patient and clinician involvement in developing IBD apps has been limited [10]. IBD app developers have prioritized developing app features while neglecting the importance of making the app user-friendly through customization and stakeholder involvement [22]. In patient involvement, there is evidence for using cocreation methods, including participatory design, to strengthen the implementation and usability of solutions [24,25].

The foundational values and key methods in participatory design are grounded in democratic ideals, emphasizing equal and genuine participation [25]. Co-design, a central method in participatory design, facilitates collaborative engagement between stakeholders and designers, ensuring that outcomes are informed by diverse perspectives and real user needs [25]. Genuine participation includes the opportunity for participants to have a say and mutual learning with stakeholders [25]. The purpose of participatory design is to forecast experiences with future technology before the technology has been developed, and because of the iterative nature of participatory design, each step in the process is planned according to the results and ideas that are created during the preceding activity [26].

This study aimed to develop an mHealth solution for patients with IBD through user involvement to strengthen communication with health care professionals.

Grounded in participatory design [27], this project is structured in 3 phases across 2 studies: study 1 covers phase 1 and study 2 includes phases 2 and 3 (Figure 1). The 3-phase project is based on the Simonsen iterative, user-centered approach [25]. Phase 1 identified user needs through 3 focus groups, each lasting 2 hours, and 111 hours of participant observations, as reported in a previous study [11]. This study presents results from phases 2 and 3, which focused on developing and testing a solution for patients with IBD, informed by phase 1 findings [11]. This study took place at 2 specialized gastroenterology outpatient clinics at Danish university hospitals from March 2019 to December 2019.

In this study, 3 patient focus groups were held to identify app content based on phase 1 findings. Two workshops involving health care professionals addressed patient input from focus groups and workflow integration, while 2 parallel workshops involving patients refined the prototype. In addition, 2 prototype tests were conducted with patients, a nurse, and an IT developer.

To encourage open dialogue, all focus groups, workshops, and prototype tests were held in neutral hospital settings, away from outpatient clinics. Three patients tested the prototype at home for 3 weeks, followed by telephone interviews after 1 week and 3 weeks (Figure 2). This early testing laid the foundation for funding applications, broader clinical testing, and full implementation.

Participants were recruited from 2 specialized gastroenterology outpatient clinics at Danish university hospitals serving regional populations. Using heterogeneous sampling [28], 14 outpatients with IBD were recruited to focus groups based on age, gender, disease, and treatment (including biologics; Table 1). Specialized IBD nurses recruited patients during clinic visits. Inclusion criteria encompassed patients with IBD attending for consultations, medical therapy, or symptom management. Exclusion criteria included non-Danish speakers and those aged <18 years. The 14 focus group patients were invited to mock-up workshops; 2 participated in workshops, and 1 also took part in prototype testing (Table 2).

Health care professionals with relevant IBD outpatient experience were recruited for 2 workshops via email and personal follow-up. IT consultants from both hospitals were also invited by email due to their expertise in eHealth development.

The study was submitted to the Scientific Ethics Committee of the Region of Southern Denmark, which deemed approval unnecessary according to Danish legislation. The study was recorded in the Region of Southern Denmark’s register of data processing activities (journal 19/47642), and the GDPR was complied with through written informed consent. The app includes 2 consent declarations, one for app use and one for research participation, both accessible before use and revocable at any time. A project description is also available within the app.

The analysis identified 6 themes of patients’ app content suggestions: easy-access messaging, agreement overviews, self-initiated patient-reported outcomes with free text, treatment and blood test notifications, an IBD knowledge base, and self-monitoring via diary and symptom registration (Textbox 2).

The most common suggestion for improving clinical practice was easy access to health care professionals. Patients proposed a messaging feature to avoid disruptive phone queues. One patient shared the following from her sticky note in a focus group:

Easy access was perceived as an essential self-management strategy when patients struggled to manage their disease. They preferred messaging for nonurgent issues over phone calls.

Contact with health care professionals often involved dialogue, symptom-related questions, advice for managing the illness, prescriptions, or booking appointments, for example:

Patients also requested to be involved in changes to their health care contacts. They suggested having an overview of their treatment and arranged contacts:

Moreover, patients wanted private discussions of their symptoms with health care professionals and suggested including a free-text option in the questionnaire to share details before treatment:

The participants had 3 additional wishes for the app: blood test and treatment notifications, a knowledge base and a diary, and a symptom registration tool.

In focus groups, patients expressed a need for blood test and treatment notifications, as they struggled to remember their appointments:

Furthermore, the patients stated a need for transparent and trustworthy information in a knowledge base on how to live with IBD:

They also requested a diary and symptom tracker to monitor flare-ups, with options to share data with health care professionals:

Patients also needed a diary tool to monitor daily activities and diets that might affect their disease:

On the basis of the 3 focus groups, an mHealth solution was developed for patients with IBD in an outpatient setting (Textbox 2). The prototype included asynchronous messaging with nurses, allowing responses within 48 hours, a compromise between patient requests for rapid replies and clinical feasibility (Figure 6). Notifications for blood tests and treatments, sent 5 and 2 days before biological therapy, respectively, were also developed. Patients were given the opportunity to complete symptom questionnaires (Simple Clinical Colitis Activity Index or Harvey-Bradshaw Index) at home and use a free-text space to express how they felt and their privacy preferences for nurse communication (Figure 7).

Content for the knowledge base, covering medical treatment, pregnancy, vaccines, and travel, was created by 4 nurses and 3 doctors, with input from a physiotherapist and dietician, all based on professional guidelines. A communications consultant advised on patient-friendly text and reviewed the content. Additional links to patient associations and blood sample ordering were included. Participants selected figures, illustrations, and an animated video with a graphic designer (Figure 8). A diary and symptom-tracking feature was developed to allow patients to record the duration and severity of symptoms during flare-ups, with the option to share these records with health care providers (Figure 9).

After 1 and 3 weeks of home testing, unstructured telephone interviews were conducted to identify needed adjustments. Patients found the app easy and safe to use for completing questionnaires, recording symptoms, and messaging nurses. They considered a 48-hour nurse response time appropriate and found the appointment overview and knowledge base clear and relevant. They found it appropriate to receive blood test and treatment notifications 2 and 5 days before treatment. However, they occasionally experienced issues such as slow performance, freezing, or being logged out, requiring reinstallation (Table 3).

Patients and health care professionals, including those not present at the prototype tests, were asked to provide feedback on the interface, usability, and content (Table 4). On the basis of their input, minor adjustments were made, for example, restricting patients to a single questionnaire (Simple Clinical Colitis Activity Index or Harvey-Bradshaw Index) to avoid completing the incorrect one (Table 3).

We developed a tailored communication app, using participatory design, to support communication between patients with IBD and health care professionals. Crucial to the study methodology were interactive processes and the genuine active participation of end users and the IT designer, which were grounded in mutual learning and collaborative decision-making. The iterative approach of participatory design was essential in developing the app, as it enabled the involved parties to revise the solutions until a suitable intervention was developed, which led to 6 features in the app. Previous studies show that patients with IBD often struggle to access health care professionals [3,9,10], despite this being crucial for self-management [3-7]. Most IBD apps focus on symptom tracking and patient-reported outcomes related to disease activity and information but lack tools to improve communication [22,34]. Patients with IBD highlight that ideal eHealth solutions should enhance communication, with online messaging preferred [10,35]. This study enabled flexible, needs-driven access by incorporating asynchronous messaging for communication between patients and health care professionals.

During development, patients requested urgent messaging with a 15-minute response during flare-ups, but this was not feasible in outpatient settings. Instead, patients and health care professionals agreed on a 48-hour asynchronous response time, with urgent issues handled by phone. This highlights the need to balance patient needs with clinical realities by involving health care professionals in the design process [36].

Patients also requested a “share symptom registration with staff” feature during severe symptoms. Despite initial concerns from health care professionals about workload, the feature was developed. This highlights not only the important democratic aspects of participatory design but also the shift of power dynamics in the participatory design process [25,36,37]. When patients are given a voice in the management of their condition, health care professionals are provided with new insights and understanding, and this mutual understanding may have a significant impact on the acceptability and implementation of the app.

Participatory design often uses tools that combine telling, making, and enacting to encourage participation [25]. In this study, sticky notes and cut-and-paste posters helped participants share ideas for their future communication with health care professionals. To enhance usability, they also chose figures and illustrations for app content and collaborated with a graphic designer to create an animation.

A strength of this study is the use of the existing platform, which is widely used in southern Denmark, secure, integrated with patient records, and GDPR-compliant, thereby supporting transferability. Conducting the study in 2 clinical settings further enhanced this. Relying on existing, supported technologies also shifts the focus toward content development rather than regulatory concerns.

As a future direction in IBD self-management, integrating wearable devices into apps could help detect flares early [38]. Studies suggest that sweat sensors for cytokines may reliably monitor disease activity. Using wearables such as activity trackers or smartwatches to feed data into the app could enhance remote monitoring and empower patients in managing their health [38].

A deeper exploration into the use of mHealth solutions by individuals with IBD could yield valuable insights.

Focus group knowledge depends on participants’ social interaction. Too much homogeneity can limit discussion, while too much heterogeneity may suppress some views [29]. In this study, patients and health care professionals participated in separate groups. This may have reduced interaction but ensured patients speak openly without fear of professional judgment. Furthermore, a limitation of this study was that the concurrent data collection and solution development restricted the opportunity for timely, in-depth data analysis. This may have impacted how emerging insights were incorporated during the design process, potentially affecting the solution’s responsiveness to participant input.

Broad participant involvement is important to gain diverse perspectives that extend beyond one’s own [37]. In our study, user involvement was based on a broad representation of health care professionals, IT consultants, and designers. However, it was challenging to recruit health care professionals, as user involvement is a time-consuming process. Nevertheless, 3 nurses and 1 doctor attended both workshops; the remaining health care professionals joined only one. This may have had a negative impact on the democratic aspect of the development process among health care professionals. However, both professional groups were represented in both workshops.

Patient recruitment also posed challenges. However, 1 man and 1 woman, both with Crohn disease (aged 36‐65 y), participated in both patient workshops. In addition to these 2 patients, only 1 woman wished to participate in prototype testing. She was also diagnosed with Crohn disease and belonged to the same age group (36-65 y). Hence, the results may not reflect the needs of all patients with IBD. However, in this study, they helped to provide insight into the wishes and needs of the patient group in the context of app development.

Finally, it cannot be excluded that additional patient information such as disease duration, social status, and health literacy could have influenced the mHealth development process.

This study resulted in the design and development of an app for patients with IBD, using participatory design in close collaboration with patients, health care professionals, and an IT designer, emphasizing mutual learning and inclusive decision-making. Thus, the participants had a significant impact on the eHealth solution, as it was tailored to their needs and clinical setting to support communication and access to care. This likely improved the app’s acceptability and potential for implementation.

The iterative participatory design process, with genuine active participation of end users and the IT designer, was essential in developing the app, as it enabled the parties involved to revise the solutions until a suitable intervention was developed. However, full participant testing is anticipated as funding becomes available. Additional studies, both planned and ongoing, will examine the app’s use in the daily clinical management of patients with IBD.