114 Chapter 5 METHOD Study setting The Stoma APPtimize trial is a double-blind multicentre RCT that will be conducted in the Netherlands. APPtimize is a blended word, combining ‘APP’ and ‘timize’ from ‘application’ and ‘optimization’. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement will be followed, and the trial will be reported in accordance with the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth (CONSORT-EHEALTH) statement. The Stoma APPtimize study will be conducted in accordance with the Declaration of Helsinki. A written informed consent form is required to participate in this study. Approval for this study was obtained from the local Medical Ethics Committee (registration number NL75119.018.20), and the study is registered on the International Clinical Trial Registry Platform (NL8895). Study population The study population consists of patients scheduled for elective or emergency ileostomy or colostomy. Patients must be 18 years of age or older and possess a smartphone operating either iOS 9 or Android 8.0, or more recent versions. Patients who meet one or more of the following criteria will not be considered for inclusion: • A Karnofsky score of ≤ 40 • Unable to understand the Dutch language • Visual impairment, unless well corrected with visual aids • Physical disabilities limiting the use of a mobile application, such as Parkinson's disease • Patients with pre-existing skin conditions, such as pemphigus, para-pemphigus and psoriasis. Investigational intervention Content development We conducted a survey study among members of stoma-related patient associations to assess patients' satisfaction and their specific needs in stoma care.12 In a focus group interview study, we aimed to gain a deeper understanding of the problems faced by patients and to determine how to improve these problems by using an app.13 Both studies were used to develop a blueprint for the mobile application. The content of the app is based on the Dutch Ostomy Care Guidelines and on information already available from the patient associations.1 The blueprint was iteratively evaluated by ‘expert’ healthcare providers and patient representatives.
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