UnknownNot Applicable

Effectiveness of Remote Self-care Education for Ostomy Patients

Italy384 participantsStarted 2023-06-14

Plain-language 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.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. having undergone a surgical operation with subsequent ostomy placement;
. being at least 18 years old of age;
. absence of cognitive decline,
. absence of any
. being able to manage the software on the smartphone
. be willing to participate to the trial and sign the informed consent form.

Exclusion criteria

. presence of a cognitive decline, assessed with a score \> 4 at the Six-item Screener
. presence of any stomal or peristomal complication
. not being able to read and speak Italian language

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-care maintenance

Timeframe: 1 month after the last intervention

Trial details

NCT IDNCT05796544

SponsorUniversity of Rome Tor Vergata

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

Contact for this trial

Ercole Vellone, Professor

+390672596871 ercole.vellone@uniroma2.it

View on ClinicalTrials.gov More Ostomy trials