van der Storm Sebastiaan L, Bemelman Willem A, van Dieren Susan, Schijven Marlies P
Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
Colorectal Dis. 2023 Oct;25(10):2071-2077. doi: 10.1111/codi.16694. Epub 2023 Aug 16.
Proper education, guidance and support is crucial before and following creation of a stoma. Patients with a stoma and their close relatives need to adapt to and cope with this new - and sometimes unforeseen - situation, which may result in insecurities and a variety of psychosocial problems. Self-efficacy is associated both with a reduction in psychosocial problems and with improved quality of life. The main objective of this study was to investigate whether self-reported quality of life of patients with a stoma can be enhanced by offering personalized and timed guidance, as well as peer contact, in a patient-centred mobile application.
A multicentre, double-blind, randomized controlled trial will be conducted. Consented adults >18 years of age who will receive an ileostomy or colostomy and possess an eligible smartphone will be included. The intervention group will be given the full version of the application (containing personalized and timed guidance, such as operation-specific information and information on the associated care pathway) to install on their smartphone. In addition, the intervention group has access to a protected peer-support platform within the app. The control group will receive a restricted version of the application that contains only generic (non-personalized) stoma-related information. The primary outcome is quality of life, 3 months postoperatively. Secondary outcomes are Patient Reported Outcome Measures (PROMs), such as psychological adaption, as well as number of complications, re-admission and re-operation rates and the length of hospital stay.
Patient enrolment began in March 2021. Data collection was not complete when this protocol was submitted.
We hypothesize that patients with a stoma who are supported by the intervention version of the app will report a significantly higher quality of life than patients with a stoma who are supported by the control version of the app (ie, are not offered personalized and timed guidance and information and do not have access to peer support in the app).
在造口形成前后，适当的教育、指导和支持至关重要。造口患者及其近亲需要适应并应对这种新的——有时是不可预见的——情况，这可能会导致不安全感和各种心理社会问题。自我效能感既与心理社会问题的减少有关，也与生活质量的提高有关。本研究的主要目的是调查在以患者为中心的移动应用程序中提供个性化、定时指导以及同伴联系，是否能提高造口患者自我报告的生活质量。
将进行一项多中心、双盲、随机对照试验。纳入年龄大于18岁、同意参与研究、将接受回肠造口术或结肠造口术且拥有符合条件智能手机的成年人。干预组将获得该应用程序的完整版（包含个性化、定时指导，如特定手术信息及相关护理路径信息），以便安装在其智能手机上。此外，干预组可在应用程序中访问受保护的同伴支持平台。对照组将获得该应用程序的受限版，其中仅包含与造口相关的通用（非个性化）信息。主要结局是术后3个月的生活质量。次要结局包括患者报告结局量表（PROMs），如心理适应情况，以及并发症数量、再入院率、再次手术率和住院时间。
患者招募于2021年3月开始。提交本方案时，数据收集尚未完成。
我们假设，使用应用程序干预版获得支持的造口患者，其报告的生活质量将显著高于使用应用程序对照版获得支持的造口患者（即未获得个性化、定时指导和信息且无法在应用程序中获得同伴支持的患者）。
