Effectiveness of Remote Self-care Education for Ostomy Patients (SELF-STOMA)

U

University of Rome Tor Vergata

Status

Enrolling

Conditions

Ostomy

Treatments

Behavioral: In-person self-care education
Behavioral: Remote self-care education

Study type

Interventional

Funder types

Other

Identifiers

NCT05796544
N.119.22

Details and patient eligibility

About

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.

Full 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.

Enrollment

384 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

384 participants in 2 patient groups

Intervention Group
Experimental group
Description:
The intervention group will receive a total of four remote educational sessions over 2 months.
Treatment:
Behavioral: Remote self-care education
Control group
Active Comparator group
Description:
The control group will receive the standard care, consisting of in-person standard education.
Treatment:
Behavioral: In-person self-care education

Trial contacts and locations

0

Loading...

Central trial contact

Ercole Vellone, Professor; Giulia Villa, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems