Clinical trial NCT05796544: Effectiveness of Remote Self-care Education for Ostomy Patients
Official title: Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ostomy
Keywords: randomized controlled trial
ostomy
telehealth
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-care maintenance
timeFrame: 1 month after the last intervention
Secondary outcomes:
measure: Self-care monitoring
timeFrame: 1 month after the last intervention
measure: Self-care management
timeFrame: 1 month after the last intervention
measure: Self-care self-efficacy
timeFrame: 1 month after the last intervention
measure: Stoma-specific quality of life
timeFrame: 1 month after the last intervention
measure: Depression
timeFrame: 1 month after the last intervention
measure: Adjustment to the stoma
timeFrame: 1 month after the last intervention
measure: Stomal and peristomal complications rates
timeFrame: 1 month after the last intervention
measure: Health care service utilization
timeFrame: 1 month after the last intervention
measure: Mobility (distance in km from the patient house to the hospital and vice versa, means of transportation used, and presence of a companion)
timeFrame: 1 month after the last intervention
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini
state: Rome
city: Alessandria
country: Italy
facility: Azienda SS. Antonio e Biagio e Cesare Arrigo -
city: Napoli
country: Italy
facility: Istituto Tumori Pascale Napoli
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia
city: Roma
country: Italy
facility: Tor Vergata Hospital
Study officials:
affiliation: Department of Biomedicine and Prevention
name: Ercole Vellone, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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