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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a total of four remote educational sessions over 2 months. |
|
| Control group | Active Comparator | The control group will receive the standard care, consisting of in-person standard education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote self-care education | Behavioral | The intervention group will receive a total of four remote educational sessions over 2 months. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ercole Vellone, Professor | Contact | +390672596871 | ercole.vellone@uniroma2.it | |
| Giulia Villa, PhD | Contact | +390226432547 | villa.giulia@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Ercole Vellone, Professor | Department of Biomedicine and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini | Recruiting | Roma | Rome | 00144 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22739426 | Background | 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. | |
| Background | 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. | ||
| Background | 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 | ||
| 38924038 |
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| In-person self-care education | Behavioral | The active comparator group will receive a total of four in-person educational sessions over 2 months. |
|
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 |
| Azienda SS. Antonio e Biagio e Cesare Arrigo - | Not yet recruiting | Alessandria | 15121 | Italy |
| Istituto Tumori Pascale Napoli | Recruiting | Naples | 80131 | Italy |
| Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia | Recruiting | Reggio Emilia | 42123 | Italy |
| Tor Vergata Hospital | Recruiting | Roma | 00133 | Italy |
| Derived |
| Iovino P, Vellone E, Campoli A, Tufano C, Esposito MR, Guberti M, Bolgeo T, Sandroni C, Sili A, Manara DF, Alvaro R, Rasero L, Villa G. Telehealth vs in-person education for enhancing self-care of ostomy patients (Self-Stoma): Protocol for a noninferiority, randomized, open-label, controlled trial. PLoS One. 2024 Jun 26;19(6):e0303015. doi: 10.1371/journal.pone.0303015. eCollection 2024. |