Remote 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
This study is testing if online self-care education can help ostomy patients take care of themselves just as well as in-person classes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Locations | 5 sites (Roma, Rome and 4 other locations) |
| Trial ID | NCT05796544 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of remote self-care education compared to traditional in-person education for patients with ostomies. Participants will be randomly assigned to either receive four remote educational sessions over two months or standard in-person education. The goal is to determine if remote education can improve self-care behaviors as effectively as in-person methods. The study aims to enhance the quality of life for ostomy patients through innovative educational approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone ostomy surgery and can manage smartphone software.
Not a fit: Patients with cognitive decline, stomal complications, or those unable to communicate in Italian may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective way for ostomy patients to manage their care.
How similar studies have performed: Other studies have shown promising results with remote education approaches for chronic conditions, suggesting potential success for this method in ostomy care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. having undergone a surgical operation with subsequent ostomy placement; 2. being at least 18 years old of age; 3. absence of cognitive decline, 4. absence of any 5. being able to manage the software on the smartphone 6. be willing to participate to the trial and sign the informed consent form. Exclusion Criteria: 1. presence of a cognitive decline, assessed with a score \> 4 at the Six-item Screener 2. presence of any stomal or peristomal complication 3. not being able to read and speak Italian language
Where this trial is running
Roma, Rome and 4 other locations
- Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini — Roma, Rome, 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 contacts
- Principal investigator: Ercole Vellone, Professor — Department of Biomedicine and Prevention
- Study coordinator: Ercole Vellone, Professor
- Email: ercole.vellone@uniroma2.it
- Phone: +390672596871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.