Effectiveness of Remote Self-care Education for Ostomy Patients (SELF-STOMA)

Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Ostomy
• Intervention / Treatment: Behavioral: Remote self-care education; Behavioral: In-person self-care education

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 Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ercole Vellone, Professor; Phone Number: +390672596871; Email: ercole.vellone@uniroma2.it
• Study Contact Backup: Name: Giulia Villa, PhD; Phone Number: +390226432547; Email: villa.giulia@hsr.it

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • Not yet recruiting
    • Azienda SS. Antonio e Biagio e Cesare Arrigo -
  • Napoli, Italy, 80131
    • Recruiting
    • Istituto Tumori Pascale Napoli
  • Reggio Emilia, Italy, 42123
    • Recruiting
    • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
  • Roma, Italy, 00133
    • Recruiting
    • Tor Vergata Hospital
  • Rome
    • Roma, Rome, Italy, 00144
      • Recruiting
      • Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Investigators: Principal Investigator: Ercole Vellone, Professor, Department of Biomedicine and Prevention

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; telehealth; ostomy
• Other Study ID Numbers: N.119.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No