Effectiveness of Remote Self-care Education for Ostomy Patients

Not Applicable

Recruiting

• Conditions: Ostomy
• Interventions: Behavioral: Remote self-care education; Behavioral: In-person self-care education

• Registration Number: NCT05796544
• Lead Sponsor: University of Rome Tor Vergata

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-03
• Study Start: 2023-06-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Self-care maintenance	1 month after the last intervention	Self-care maintenance will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care maintenance

Secondary Outcome Measures

Name	Time	Method
Adjustment to the stoma	1 month after the last intervention	Adjustment to the stoma will be measured with the Stoma Adjustment Inventory-23. scores on this scale range from 0 to 92, with higher scores meaning better adjustment
Self-care monitoring	1 month after the last intervention	Self-care monitoring will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care monitoring
Self-care self-efficacy	1 month after the last intervention	Self-care self-efficacy will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care self-efficacy
Mobility (distance in km from the patient house to the hospital and vice versa, means of transportation used, and presence of a companion)	1 month after the last intervention	Mobility will be collected with a questionnaire developed by the research team.
Self-care management	1 month after the last intervention	Self-care management will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care management
Stoma-specific quality of life	1 month after the last intervention	Stoma-specific quality of life will be measured with the Stoma Specific Quality of Life Index- Scores on this scale range from 20 to 80, with higher scores meaning higher quality of life
Depression	1 month after the last intervention	Depression will be measured with the Patient Health Questionnaire 9 (PHQ-9). Scores on this scale range from 0 to 27, with higher scores indicating higher depression
Stomal and peristomal complications rates	1 month after the last intervention	Stomal and peristomal complications rates will be collected with a questionnaire developed by the research team.
Health care service utilization	1 month after the last intervention	Health care service utilization will be collected with a questionnaire developed by the research team.

Trial Locations

Locations (5)

Tor Vergata Hospital; 🇮🇹 Roma, Italy

Istituto Tumori Pascale Napoli; 🇮🇹 Napoli, Italy

Azienda SS. Antonio e Biagio e Cesare Arrigo -; 🇮🇹 Alessandria, Italy

Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini; 🇮🇹 Roma, Rome, Italy

Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy