SELF-STOMA: Effectiveness of Remote Self-care Education for Ostomy Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group The intervention group will receive a total of four remote educational sessions over 2 months. |
Behavioral: Remote self-care education
The intervention group will receive a total of four remote educational sessions over 2 months.
|
| Active Comparator: Control group The control group will receive the standard care, consisting of in-person standard education. |
Behavioral: In-person self-care education
The active comparator group will receive a total of four in-person educational sessions over 2 months.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
having undergone a surgical operation with subsequent ostomy placement;
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being at least 18 years old of age;
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absence of cognitive decline,
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absence of any
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being able to manage the software on the smartphone
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be willing to participate to the trial and sign the informed consent form.
Exclusion Criteria:
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presence of a cognitive decline, assessed with a score > 4 at the Six-item Screener
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presence of any stomal or peristomal complication
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not being able to read and speak Italian language
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini | Roma | Rome | Italy | 00144 |
| 2 | Azienda SS. Antonio e Biagio e Cesare Arrigo - | Alessandria | Italy | 15121 | |
| 3 | Istituto Tumori Pascale Napoli | Napoli | Italy | 80131 | |
| 4 | Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia | Reggio Emilia | Italy | 42123 | |
| 5 | Tor Vergata Hospital | Roma | Italy | 00133 |
Sponsors and Collaborators
- University of Rome Tor Vergata
Investigators
- Principal Investigator: Ercole Vellone, Professor, Department of Biomedicine and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
- 2. Villa, G., Vellone, E., Sciara, S., Stievano, A., Proietti, M. G., Manara, D. F., ... & Pantaleo, G. (2019). Two new tools for self-care in ostomy patients and their informal caregivers: Psychosocial, clinical, and operative aspects. International Journal of Urological Nursing, 13(1), 23-30.
- Costa, A., Maria, M., Campos, C., & Santos, J. D. (2020). Effect of educational intervention in postoperative people with intestinal elimination stomies: systematic review. doi:10.6018/eglobal.19.1.368501
- Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.
- N.119.22