The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients
1 other identifier
interventional
34
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2024
CompletedFirst Submitted
Initial submission to the registry
April 24, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJuly 30, 2024
July 1, 2024
11 months
April 24, 2024
July 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
routine care
NO INTERVENTIONTaking routine care measures
self-management education program
EXPERIMENTALIntervention in accordance with the constructed self-management education program
Interventions
Intervention through a self-management education program constructed through evidence summarization and expert correspondence.
Eligibility Criteria
You may qualify if:
- age ≥60 years
- first enterostomy surgery
- informed consent to voluntarily participate in this study.
You may not qualify if:
- verbal communication disorder; cognitive dysfunction or history of mental illness;
- visual and manual mobility impairment unable to perform stoma care operations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yan Xue
Wuxi, Jiangsu, 214001, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- nurse
Study Record Dates
First Submitted
April 24, 2024
First Posted
April 30, 2024
Study Start
January 20, 2024
Primary Completion
December 1, 2024
Study Completion
January 1, 2025
Last Updated
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share