115 5 A personalized app to improve quality of life of patients with a stoma: A protocol for a multicentre randomized controlled trial Technical development The application is developed by a third party. The application works on smartphones compatible with the operating systems either iOS 9 or Android 8.0, or more recent versions. Smartphone applications influencing the diagnosis, treatment and monitoring of diseases are considered as medical devices and need to meet additional quality and safety requirements.14 The ‘Stoma App’ application is developed specifically for patients undergoing ileostomy or colostomy surgery with the aim of providing personalized and timed guidance and facilitating peer contact and is therefore considered a medical device. The app is CE-marked (NL-CA002-2020-53630). The app is built to comply with the General Data Protection Regulation and follows the data and security guideline ISO 27001.15 Usability testing The usability of the application was tested by a group of patients, representative of two stoma-related patient associations and the Dutch Ostomy Nurse Association, and healthcare providers. The usability and weaknesses of the application were evaluated in several walkthrough sessions, and adjustments were made. Furthermore, the application will be monitored continuously during the trial. Intervention group Patients in the intervention group use the application immediately after inclusion until 1 year postoperatively or stoma reversal. The main goals of the application are: (1) to provide reliable information, (2) to stimulate self-management and self-confidence, (3) to monitor the progress of self-care and self-management, and (4) to provide support to patients from fellow peers. Figure 1 shows the layout of the application. The information will be provided in an information library, including illustrations and videos, and in a personalized timeline, both based on the Dutch guideline for stoma care.1 The timeline is personalized based on the type of stoma (ileostomy or colostomy), type of surgery (elective or emergency) and operation indication (malign or benign) and is timed based on the date of the operation and the date of discharge from hospital. As these dates can change due to unexpected circumstances, patients can change these dates when necessary. To prevent the patient from becoming overwhelmed by unnecessary information, the timeline shows information only when it is relevant. All information received by the participant can be recalled at any time. Questions or notifications will be pushed through the application to inform and prompt the patient. The questions also function as a registration tool for fluid intake and stoma output and for the elements of stoma self-care that are fulfilled. This may improve the insight of patients regarding their progress in self-management. Patients will also be able to have peer contact with other patients using the public (restricted) version of the application. A suggestion list of peers, all of whom can be contacted, is generated based on the type of stoma, operation indication, and age and sex of the patient. Only
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