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Randomized Controlled Trial
. 2024 Mar;38(3):1442-1453.
doi: 10.1007/s00464-023-10593-x. Epub 2024 Jan 8.

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

Sebastiaan L van der Storm  1   2   3   4 , Esther C J Consten  5   6 , Marc J P M Govaert  7 , Jurriaan B Tuynman  8 , Steven J Oosterling  9 , Brechtje A Grotenhuis  10 , Anke B Smits  11 , Hendrik A Marsman  12 , Charles C van Rossem  13 , Eino B van Duyn  14 , Lindsey C F de Nes  15 , Emiel Verdaasdonk  16 , Tammo S de Vries Reilingh  17 , Wouter Vening  18 , Willem A Bemelman  19   20 , Marlies P Schijven  21   22   23   24 ; Stoma APPtimize collaborative study group
Collaborators, Affiliations
Randomized Controlled Trial

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

Sebastiaan L van der Storm et al. Surg Endosc. 2024 Mar.

Abstract

Background: 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 and 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.

Keywords: Colorectal surgery; Ehealth; Mhealth; Mobile application; Quality of life; Stoma.

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Conflict of interest statement

Sebastiaan van der Storm is the content developer of the app and Marlies Schijven is the owner of the app. Eshter Consten declares she is Proctor for Intuitive Surgical. Willem Bemelman declares that he has received scientific grants from VIFOR and has received speaker fees from Janssen, Tilotts, Takeda, and Galapagos. The app development and study was funded by the Dutch “Stomach Liver Intestine Foundation” (Grant No. ZP 19-09) and SIDN funds (Grant No. 191124). Mark Govaert, Jurriaan Tuynman, Steven Oosterling, Brechtje Grotenhuis, Anke Smits, Hendrik Marsman, Charles van Rossem, Eino van Duyn, Lindsey de Nes, Emiel Verdaasdonk, Tammo de Vries Reiling, and Wouter Vening have no conflicts of interest or financial ties to disclose.

Figures

Fig. 1
Fig. 1
Screenshots of the Stoma App (in the Dutch language). A The splash screen when starting up the app shows the cooperating patient and professional associations. B The information library containing relevant information. C Information and illustration of an ileostomy. D The personalised information timeline which is personalised based on the type of stoma, operation setting, and operation indication, and timed based on the operation and hospital discharge dates read text boxes are ticked off and the left bar illustrates the patients process in the pathway (in this case, in admission). E “My overview” in which patients can enter their process. F Registration of the stoma production. G Peer-support platform, the app provides a suggestion list of peers which is based on the type of stoma, operation indication, age, and sex, all of which can be contacted H) One–one peer chat
Fig. 2
Fig. 2
Treatment assignment and study flow
See this image and copyright information in PMC

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