Construction and Validation of a Postoperative Self-management Education Program for Elderly Patients With Enterostomies

Elderly Clinical Trial

Official title:

Construction and Validation of a Postoperative Self-management Education Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06392646
• Other study ID #: Wuxi2PH
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Wuxi No. 2 People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies. It aims to answer the main question of whether a self-management education program can improve self-management skills, quality of life, and reduce family caregiver burden in elderly patients with enterostomies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• age =60 years
• first enterostomy surgery
• informed consent to voluntarily participate in this study.

Exclusion Criteria:

• verbal communication disorder; cognitive dysfunction or history of mental illness;
• visual and manual mobility impairment unable to perform stoma care operations.

Related Conditions & MeSH terms

• Education
• Elderly
• Enterostomy
• Self-management

Intervention

Behavioral:
• self-management education program
Intervention through a self-management education program constructed through evidence summarization and expert correspondence.

Locations

Country	Name	City	State
China	Yan Xue	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wuxi No. 2 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-management	Self-management behavior questionnaire for patients with enterostomies. The questionnaire has a total score of 40-200, with higher scores being associated with better stoma self-management behaviours.	during hospitalization, approximately 5 days and post-discharge, 1month
Primary	the quality of life	City of Hope Quality of Life-ostomy Questionaire, COH-QOL-OQ. The scale has a total score of 0-320, with higher scores being associated with higher quality of life.	during hospitalization, approximately 5 days and post-discharge, 1month
Primary	Caregiver burden	Zarit Burden Interview,ZBI. The scale is scored on a total scale of 0-88, with the higher the score, the higher the burden on the carer.	during hospitalization, approximately 5 days and post-discharge, 1month