Effectiveness of Remote Self-care Education for Ostomy Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial

Conditions
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Ostomy

Intervention / Treatment
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* Behavioral: Remote self-care education
* Behavioral: In-person self-care education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group will receive a total of four remote educational sessions over 2 months. | Behavioral: Remote self-care education<br>* The intervention group will receive a total of four remote educational sessions over 2 months.<br>|
| Active Comparator: Control group<br>The control group will receive the standard care, consisting of in-person standard education. | Behavioral: In-person self-care education<br>* The active comparator group will receive a total of four in-person educational sessions over 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care maintenance | 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 | 1 month after the last intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care monitoring | 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 | 1 month after the last intervention | 
| Self-care management | 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 | 1 month after the last intervention | 
| Self-care self-efficacy | 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 | 1 month after the last intervention | 
| Stoma-specific quality of life | 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 | 1 month after the last intervention | 
| Depression | 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 | 1 month after the last intervention | 
| Adjustment to the stoma | 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 | 1 month after the last intervention | 
| Stomal and peristomal complications rates | Stomal and peristomal complications rates will be collected with a questionnaire developed by the research team. | 1 month after the last intervention | 
| Health care service utilization | Health care service utilization will be collected with a questionnaire developed by the research team. | 1 month after the last intervention | 
| Mobility (distance in km from the patient house to the hospital and vice versa, means of transportation used, and presence of a companion) | Mobility will be collected with a questionnaire developed by the research team. | 1 month after the last intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, ostomy, telehealth