128 Chapter 6 materials, nutrition, exercise, emotional and sexual wellbeing and travelling. One is also able to self-monitor progress in stoma self-care. The layout of the full version of the Stoma App is depicted in Figure 1 in Chapter 6. The Stoma App is based on the Dutch Ostomy Care Guidelines and built with patients and providers, and caters to various patients’ needs.12,13 By conducting this double-blind randomized controlled trial (RCT), we aimed to investigate whether personalised and timed guidance, and peer contact in a patient-centred app significantly improves the Stoma quality of life (Stoma QoL). METHODS Study setting The Stoma APPtimize trial is a double-blind multicentre randomized controlled trial that was conducted since March 2021 in two academic hospital centres and across twelve teaching hospitals in the Netherlands. Data collection for the short-term outcomes was completed in April 2023. The study was approved by the local medical ethics committee of Amsterdam UMC registration number NL75119.018.20). The study protocol has been published previously.16 The study is reported according CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth) checklist.17 Study population Patients were eligible if they received an elective or emergency ileostomy or colostomy, were aged 18 years or older and had a smartphone operating on at least iOS 9 or Android 8.0. Patients who met one or more of the following criteria were not considered for inclusion: • Patients with a Karnofsky performance score ≤40 • Incompetence of understanding the Dutch language • Visual impairment, unless well corrected with visual aids • Physical disabilities limiting the use of a mobile app, such as Parkinson’s disease • Patients with pre-existing skin conditions, such as pemphigus, para-pemphigus, and psoriasis. Group allocation and blinding After inclusion, participants were provided with an unique generated access code that blindly randomized them to either the intervention or the control (1:1) group using block sizes of two, four, and six. Randomization was stratified for indication for surgery (benign or malignant) and type of stoma (ileostomy or colostomy). Only the coordinating researcher was unblinded as he provided the app’s instructions. Participants were instructed not to
RkJQdWJsaXNoZXIy MTk4NDMw