Ostomy
Conditions
Keywords
randomized controlled trial, ostomy, telehealth
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.
Interventions
BEHAVIORALRemote self-care education
The intervention group will receive a total of four remote educational sessions over 2 months.
BEHAVIORALIn-person self-care education
The active comparator group will receive a total of four in-person educational sessions over 2 months.
Sponsors
University of Rome Tor Vergata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
Countries
Italy
Contacts
Primary ContactErcole Vellone, Professor
Backup ContactGiulia Villa, PhD
Outcome results
None listed