Better stoma care using the Stoma App: does it help? A first randomized double-blind clinical trial on the effect of mobile healthcare on quality of life in stoma patients

A total of 263 participants provided informed consent and were randomized. Of these participants, 36 participants did not receive the treatment allocation (did not download or use the Stoma App), 96 participants received the full version Stoma App (intervention group), and 112 received the restricted version of the Stoma App (control group, Fig. 2). The baseline characteristics of the participants, as presented in Table 1, were similar between the two groups except for a significantly worse overall preoperative performance score in the intervention group (87.0 vs 89.6, p = 0.041). The mean age of the study population was 56 years; the majority received a colostomy (59.6%) and the majority was operated upon in a non-acute, elective setting (63.5%). Both groups expressed overall sufficient scores on the mobile proficiency questionnaire. On average, patients in the elective setting started using the app 21 days before surgery, while patients in the emergency setting started using the app 5 days after surgery. From the patients in the intervention group, 20.1% utilized the peer contact function at least once.

The results on the Stoma QoL questionnaire at two weeks, one month, and three months postoperatively are presented in Table 2. At first sight, it appears that there were no significant improvements in the Stoma QoL for the intervention group. However, after adjusting for confounding factors using multivariate linear regression analysis, a significant improvement in reported quality of life was observed at the timestamp of one-month postoperative (Table 3). Confounders included the quality of life at baseline, the readmission rate, and reported psychological problems.

Patients in both groups had five contact moments (face to face or telephonic) at the outpatient clinical with a stoma nurse in the postoperative phase. Patients in academic medical centers had significantly fewer contacts in total, compared to patients in teaching hospitals (2.1 vs. 2.8 at 1 month p = 0.019; 1.5 vs 2.8 at 3 months p < 0.001). This was independent from the incidence of stoma-related problems, suggesting different postoperative pathways or low-threshold contact in teaching hospitals. Self-reported problems were present in both the intervention and control groups. Physical problems were reported by 74.3% vs. 69.4% of patients at 1-month (p = 0.500) and 68.5% vs. 65.6% at 3 month interval (p = 0.411). Similarly, psychological problems were reported by 72.2% vs. 73.2% of patients at 1 month (p = 1.000) and 68.1% vs. 64.8% at three months (p = 0.740). The readmission rate of the intervention group was significantly higher at 1 month after surgery (20.4% vs 10.0%, p  = 0.047). Most readmissions were due to intra-abdominal abscesses (7.2%) or ileus (2.4%), see Table 4. The number of reported comorbidities in the intervention group was significantly lower (9.7% vs. 20.9%). Other clinical and patient-reported outcomes were comparable between the groups (Table 5).

Providing adequate stoma care is essential to help patients cope with their stoma and improve their QoL. To date, it is reported in literature that patients experience a lack of adequate and personalized information provision, postoperative care, and support and are in need of contact with peer patients especially when they are out of hospital [13, 14]. To address these shortcomings and optimize stoma care, a patient-centered mobile app tailored to meet the needs and preferences of stoma patients holds significant potential. This study examined the effects of having timely, individualized information, and peer contact available via the Stoma App on patients with ileostomies or colostomies, as well as the value of having information that is both accessible and trustworthy.

The intervention version of the Stoma App demonstrated a significant improvement in the stoma quality of life by 3.1 (p = 0.038) in the multivariate analysis, at one month after surgery. This finding holds significant importance, especially considering that the immediate postoperative period is often characterized by various insecurities and psychosocial challenges [21]. In this period, patients may not always have adequate self-efficacy, which may result in insecurity, social impairment, or isolation. In return, this may lead to an increase in emergency department visits without readmission (patients being insecure) [22], or in contrast, and even worse, to an increase in readmission (patients waiting too long to present themselves) [23]. In the longer postoperative period, patients generally have higher self-efficacy and thus may benefit less from the app. In our study, the Stoma App showed significant improvement in the primary outcome measurement ‘quality of life’ after correction for confounders, but not in the secondary outcome measures. Interestingly, the intervention group had a significantly higher readmission rate one month after surgery. This was primarily due to operation-related complications, such as intra-abdominal abscess or ileus (Table 4). It is highly unlikely that stoma-related guidance or peer contact have any influence on these complications, as the app does not provide any information, guidance, or advice related to these specific medical conditions, nor is provided information likely to be of influence. However, the significantly lower Karnofsky performance score of the intervention group may be attributed to the higher readmission rate. Co-morbidities were less frequently reported in the intervention group in the same period. This may result from underreporting in the intervention group, as complications or readmissions are likely to obscure other problems.

Two stoma-related apps have been described in literature with inconsistent user outcomes [24, 25]. These apps were less capacious in content and user interface than the Stoma App, lacking a proper (user-) design and development testing process. In contrast, development of the Stoma App was based on an assessment of the actual problems that patients themselves reported to encounter in stoma care and their specific needs and desired functionalities [13, 14]. To that end, we involved both patient associations and the stoma nurse association intensively [26‐28]. Indeed, the target group and stakeholders were involved in the development of the app and in pilot testing, to ensure its usability and relevance. Possible features that the apps can offer to patients were explored in beta testing before the app was registered in the app stores. This is a vital step in building good apps, as apps can provide many ways of providing information.

Although apps have great potential to improve and support healthcare, it is crucial that these apps are thoughtfully designed in terms of content and user interface, maintain technical stability, and adhere to privacy and medical device legislation to ensure their effectiveness and safety [29]. When developing an app, one must realize that app features are sometimes costly to build, protect, and maintain; and there is a ‘nice to have’ and ‘need to have’ that needs to be explored. It is important to acknowledge that apps are at risk of poor implementation and underutilization in healthcare if not built well. Addressing these concerns is crucial, as apps have additional features and benefits in comparison to a website or digital paper, which may positively impact patient care [16]. Therefore, to optimize and prepare for future implementation in standard care, the Stoma App was provided by ostomy nurses to their patients in this trial. And also, our partner in development and spreading insights -the Dutch patient associations- propagated the app and patient stories about it on their website and in their newsletters.

We deliberately chose not to compare the full version of the app with ‘care as usual’ –as we expected this outcome evaluation would be biased. Normal routine of stoma care consists of a one-time informative conversation with a physician or stoma nurse before surgery, possibly supported by a paper folder or a referral to a website. Providing information on a stoma-especially if the conversation immediately follows a conversation in which the message is given that one is diagnosed with cancer or another illness, is often not remembered by patients [30]. Thus, it is highly likely that having easily accessible information in an app on the own smartphone as an extra to normal routine will be valued more highly than not having such an app. Therefore, we compared two versions of the app to strengthen the evidence supporting the app’s impact and adequately evaluate the effectiveness the design’s add-ons, as suggested by patients. As the app was built with a subsidiary that is to be depleted, insurers require robust evidence to financially support an app built as ‘software as a medical device.’ We aim to keep offering this app free of charge to all stoma patients, in and outside of the Netherlands for many more patients to benefit from. For that, one needs evidence on the effect of the app as a medical device in patients as a whole, while considering the proposed benefits of the costly elements.

Although there was a significant increase in the quality of life of patients using the intervention version of the Stoma App, the uptake and utilization of the app can be further optimized. It is important to acknowledge that the Stoma App suffered from technical issues during the trial. Some of these were not adequately addressed or resolved in a timely manner by the app developer. These technical issues mainly affected the timed information feature of sending out push notifications to patient. This must be considered a crucial component of the timed intervention version of the app. This issue has now been resolved in further development and scaling up the app, including migration of the app and choosing a different app developer. This needed to be done in order to futureproof and sustain the app implemented in normal clinical practice, fitting current and future technical and legal requirements, and operational stability. Building an app and researching it-even after committing to a pilot testing phase for technical issues- is a journey in itself. New insights are bound to be derived and are generated by actual use and implementation research itself. It is important to acknowledge this phenomenon, be transparent about it, and act accordingly. It is encouraging that despite the technical issues, on the primary outcome measurement significant difference was noted. This strengthens our belief that with optimal functionality, the value of personalization and peer support is likely to be higher than now visible.

The need for peer contact is frequently reported in literature by patients having a stoma [11, 13, 14, 22]. However, only one out of five patients in the intervention group used the peer contact function. This may indicate that, when asked, patients may have responded socially desirable to the question of whether peer support is important for them. It seems that for the majority of patients in our study, the opportunity to have peer contact via an app is not a ‘need to have’ feature, but rather a ‘nice to have.’ That said, one out of five patients used this feature, being either curious or in need of the support or opinion of a peer. It would be interesting to know, if these patients have a weaker social network than the ones who did not use it, but that could not be retrieved from data. And one may argue that one out of five is relevant number in itself to support the need for this feature.

Although the app is freely available in the app stores and publicized by patient associations, the involvement of local stoma nurses proved to be key in the process and success of the Stoma App [31]. The stoma nurses recruited and onboarded the patients for the trial, which took approximately 15 min. In addition, stoma nurses helped patients not familiar with app installation and with overcoming some digital literacy issues using the app. We consider this to be a best fit in the normal work routine, as patients in both groups needed a code to access the app. Of course, we needed to ensure that there were only patients having or getting a stoma as users in the app. Throughout the study, the participating stoma nurses were updated about course of the study and new app insights. Also, non-participating stoma nurses were informed about the trial and the app on national stoma congresses, many of them expressing interest in the app. In our study, as in many multicenter trials, patient recruitment varied between the study sites. That can be explained because some nurses actively integrated the app into the standard care pathway, while others did not and sometimes forget about the app.

This study has several limitations. Mostly importantly, it is highly likely that the results were significantly and negatively influenced by technical issues within the intervention version of the app. When developing a mobile app, careful consideration should be given to selecting a qualified app developer. But one should also clearly agree on what is included in app maintenance –and what are agreeable timeframes for maintenance—when an app is in trial. This, to ensure adequate support also after build and registration in app stores [15]. Although the developer possessed relevant certifications to ensure compliance to privacy and quality requirements, as well as having prior experience in the development of medical apps, the technical support and timely reaction time for this app proved to be inadequate. Especially for apps in medical trials, it is crucial to establish a solid agreement that obligates the developer to promptly detect and correct any technical problems that may arise. That said, even with the technical impairments now resolved, the intervention version of the app proved to be superior in supporting quality of life of stoma patients. Second, the intervention group had a significantly slightly worse preoperative clinical condition (and higher readmission rate) which may have negatively impacted the results. Third, the distribution of participants between the intervention and control groups was unequal, resulting from exclusions before receiving treatment (withdrawal, did not receive treatment), or because they did not receive an anticipated stoma. Consequently, this imbalance might have influenced the statistical significance of the results, as the differences in outcomes would need to be more substantial to be significant. Lastly, results may be biased as questionnaires were to be completed in the app itself. This method allowed participants to “click through” the questions quickly, potentially leading to less thoughtful answers and influencing the accuracy and reliability of the data collected.

To further explore and address the need for optimization of the uptake and utilization of the app, we are investigating facilitators and barriers in patients’ and stoma nurses’ engagement using semi-structured interviews. It is advised by our participating stoma nurses and authors incorporate the app into the care pathway, as the app requires limited time from personnel, it simulates consistent engagement and utilization by stoma nurses. By doing so, to provide more patients with the benefits of the app.

The Stoma App—software as a medical device—improves the quality of life of stoma patients. This is a significant step forward in the optimization of stoma care. The app provides patients with ileostomies or colostomies with personalized support, peer contact if they need or desire to have such contact on a voluntary basis and a reliable, easily accessible base of information. This study demonstrated the app’s effectiveness in improving stoma quality of life in the critical postoperative period. Considering the study outcomes and the minimal time commitment required from healthcare personnel, it is highly recommended that the app be integrated into standard stoma care pathways.