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

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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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