About this trial
This single-blind, parallel-group randomized controlled trial aims to evaluate the effects of a mobile app-based education, counseling, and follow-up program on stoma adaptation and quality of life in adults with a newly ostomy. The study will be conducted at the Stomatherapy Unit of Gazi University Health Research and Application Center (Ankara, Turkey). Participants meeting the inclusion criteria (n=66) will be assigned to intervention (mobile app support + standard care) and control (standard care only) groups in a 1:1 ratio via block randomization; participants will be kept unaware of their group assignment. Participants in the intervention group will download the "Stomatherapy-M" app on the day of discharge and will access structured educational content, receive nurse counseling (messaging and scheduled video calls), and share scheduled follow-up records regularly for six months. Follow-up frequency will be weekly in the first month, biweekly in the second month, and monthly in the following months. Primary outcomes; Adaptation to the stoma (Ostomy Adjustment Inventory) and stoma-related quality of life (Quality of Life Adaptation Scale) assessed at 15 days and 1, 3, and 6 months after discharge. App usability (MAUS) will be measured at 6 months only in the intervention group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Stomaterapi-M Mobile Application Support
BehavioralParticipants will use the "Stomaterapi-M" mobile application for 6 months starting on discharge day. The app provides structured stoma education (texts and videos), nurse counseling via in-app messaging and scheduled video calls, and a planned monitoring module. Monitoring frequency is weekly during month 1, bi-weekly during month 2, and monthly during months 3-6, with reminder notifications before each planned entry.
Treatment groups
Trial outcomes
Primary outcomes
Ostomy Adjustment Inventory (OAI) Total Score
Adaptation of Quality of Life Scale (AQLS) Total and Subscale Scores
Secondary outcomes
Mobile Application Usability Scale (MAUS) Score
Locations
Sponsors and contacts
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