Interventional Recruiting
NCT05796544 on ClinicalTrials.gov
Effectiveness of Remote Self-care Education for Ostomy Patients
Official title: Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial
- Sponsor: University of Rome Tor Vergata
- Enrollment: 384 (Estimated)
- Study start: 2023-06-14 (Actual)
- Primary completion: 2024-12-01 (Estimated)
- Study completion: 2025-04-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Double (Investigator, Outcomes Assessor)
- PrimaryPurpose: Supportive Care
Brief Summary
The primary aim of this study is to evaluate whether remote education is as effective as in-person education in improving self-care behaviors of ostomy patients.
Conditions
- Ostomy
Intervention / Treatment
- Behavioral: Remote self-care education
- Behavioral: In-person self-care education
Primary Outcome Measures
-
Self-care maintenance
(1 month after the last intervention)
Self-care maintenance will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care maintenance
Countries
Italy
Locations and Investigators
- Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini, Roma, Italy (Recruiting)
- Azienda SS. Antonio e Biagio e Cesare Arrigo -, Alessandria, Italy (Not yet recruiting)
- Istituto Tumori Pascale Napoli, Napoli, Italy (Recruiting)
- Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia, Reggio Emilia, Italy (Recruiting)
- Tor Vergata Hospital, Roma, Italy (Recruiting)
Study Officials
- Ercole Vellone, Professor (Principal Investigator) — Department of Biomedicine and Prevention