Trials / Unknown
UnknownNCT05796544
Effectiveness of Remote Self-care Education for Ostomy Patients
Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 384 (estimated)
- Sponsor
- University of Rome Tor Vergata · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
After signing the informed consent form, patients with ostomy will be assigned to the intervention or active control group (1:1). The intervention group will receive a total of four remote educational sessions over 2 months. The control group will receive the standard care, consisting of in-person standard education.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Remote self-care education | The intervention group will receive a total of four remote educational sessions over 2 months. |
| BEHAVIORAL | In-person self-care education | The active comparator group will receive a total of four in-person educational sessions over 2 months. |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2024-12-01
- Completion
- 2025-04-01
- First posted
- 2023-04-03
- Last updated
- 2023-09-15
Locations
5 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT05796544. Inclusion in this directory is not an endorsement.