Effectiveness of Remote Self-care Education for Ostomy Patients

Ostomy Clinical Trial

— SELF-STOMA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796544
• Other study ID #: N.119.22
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: September 2023
• Source: University of Rome Tor Vergata
• Contact: Ercole Vellone, Professor
• Phone: +390672596871
• Email: ercole.vellone[@]uniroma2.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: April 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Ostomy

Intervention

Behavioral:
• Remote self-care education
The intervention group will receive a total of four remote educational sessions over 2 months.
• In-person self-care education
The active comparator group will receive a total of four in-person educational sessions over 2 months.

Locations

Country	Name	City	State
Italy	Azienda SS. Antonio e Biagio e Cesare Arrigo -	Alessandria
Italy	Istituto Tumori Pascale Napoli	Napoli
Italy	Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia	Reggio Emilia
Italy	Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini	Roma	Rome
Italy	Tor Vergata Hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	1 month after the last intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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