The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients

July 26, 2024 updated by: Xue Yan, Wuxi No. 2 People's Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214001
        • Yan Xue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: routine care
Taking routine care measures
Experimental: self-management education program
Intervention in accordance with the constructed self-management education program
Behavioral: self-management education program
Intervention through a self-management education program constructed through evidence summarization and expert correspondence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-management
Time Frame: during hospitalization, approximately 5 days and post-discharge, 1month
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
Time Frame: during hospitalization, approximately 5 days and post-discharge, 1month
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
Time Frame: during hospitalization, approximately 5 days and post-discharge, 1month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuxi No. 2 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Wuxi2PH

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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