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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06392646
Other study ID # Wuxi2PH
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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