Effect of a Mobile Application on Stoma Adaptation and Quality of Life

NCT07260539 | Not Yet Recruiting

• 2 other identifiers: GU-HM-FKE-02TDK-2025-10011
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colostomy - Stoma; Intestinal Stoma; Ileostomy

Keywords

Mobile application; ostomy; adaptation; quality of life

Outcome Measures

Primary Outcomes (2)

• Ostomy Adjustment Inventory (OAI) Total Score

  Post-discharge Day 15, Month 1, Month 3, Month 6

• Adaptation of Quality of Life Scale (AQLS) Total and Subscale Scores

  Post-discharge Day 15, Month 1, Month 3, and Month 6

Secondary Outcomes (1)

• Mobile Application Usability Scale (MAUS) Score

  Month 6 (intervention group only)

Study Arms (2)

Experimental

EXPERIMENTAL

Participants will install the "Stomaterapi-M" mobile application on discharge day and will receive structured education (texts/videos), nurse counseling via in-app messaging and scheduled video calls, and planned monitoring for 6 months (weekly in month 1, bi-weekly in month 2, monthly in months 3-6) in addition to standard care.

Behavioral: Stomaterapi-M Mobile Application Support

Standard Care

NO INTERVENTION

Participants will receive routine stomatherapy education, counseling, and follow-up provided by the clinic. Outcome assessments will be completed digitally at the same time points as the intervention group, without access to the mobile application.

Interventions

Stomaterapi-M Mobile Application Support BEHAVIORAL

Participants 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years Able to read and write Turkish Undergoing ostomy surgery for the first time Permanent ostomy or expected to remain for at least 6 months No major mental, physical, or communication impairment Owns an iOS/Android smartphone with active internet access Able to use mobile applications Uses WhatsApp for digital form submission during follow-up

You may not qualify if:

• Receiving stoma-related education or counseling from another institution or professional during the study period

Sponsors & Collaborators

• Gazi University: lead

Central Study Contacts

FERZAN KALAYCI EMEK, RESEARCH Asistan

CONTACT

+905436540498; ferzan.kalayciemek@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to group allocation. The intervention is delivered by the research team, therefore care providers and investigators are not blinded. Outcomes are self-reported through digital forms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESEARCH ASSISTANT

Model Details: Participants will be assigned to one of two parallel groups (1:1). After baseline/pre-discharge assessment, eligible adults with a newly created intestinal stoma will be randomized using block randomization to either (A) mobile app-based education, nurse counseling, and structured monitoring plus standard care, or (B) standard care only. The trial is single-blind: participants are unaware of group assignment. Ostomy adaptation and stoma-related quality of life will be assessed at post-discharge day 15 and at months 1, 3, and 6. App usability will be assessed in Group A at month 6. All analyses will follow the intention-to-treat principle.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share