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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
384
The intervention group will receive a total of four remote educational sessions over 2 months.
The active comparator group will receive a total of four in-person educational sessions over 2 months.
Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini
Roma, Rome, Italy
RECRUITINGAzienda SS. Antonio e Biagio e Cesare Arrigo -
Alessandria, Italy
NOT_YET_RECRUITINGIstituto Tumori Pascale Napoli
Napoli, Italy
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
Time frame: 1 month after the last intervention
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 month after the last intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia
Reggio Emilia, Italy
RECRUITINGTor Vergata Hospital
Roma, Italy
RECRUITINGAdjustment 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month after the last intervention