126 Chapter 6 ABSTRACT Introduction: Receiving a stoma significantly impacts patients' quality of life. Coping with this new situation can be difficult, which may result in a variety of physical and psychosocial problems. It is essential to provide adequate guidance to help patients cope with their stoma, as this positively influences self-efficacy in return. Higher self-efficacy reduces psychosocial problems increasing patient’s quality of life. This study investigates whether a new mobile application, the Stoma App, improves quality of life. And if personalized guidance, timed support, and peer contact offered as an in-app surplus makes a difference. Methods: A double-blind, randomized controlled trial was conducted between March 2021 and April 2023. Patients aged > 18 years undergoing ileostomy or colostomy surgery, in possession of a compatible smartphone were included. The intervention group received the full version of the app containing personalized and time guidance, peer support and generic (non-personalized) stoma-related information. The control group received a restricted version with only generic information. Primary outcome was stoma quality of life. Secondary outcomes included psychological adaption, complications, re-admittance, reoperations and length of hospital stay. Results: The intervention version of the app was used by 96 patients, the control version by 112 patients. After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month postoperatively (p=0.038). On secondary outcomes, no significant improvements could be retrieved of the intervention group. Conclusion: The Stoma App improves the quality of life of stoma patients. Peer-support and personalized guidance are of significant importance in building self-efficacy. It is to be recommended to implement Stoma app –freely available software qualifying as a medical device- in standard stoma care pathways for the benefits of both patients and healthcare providers. Funding: Maag Lever Darm Stichting (ZP19-09) and SIDN fonds (191124)
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