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Active, Not Recruiting

NCT Number: NCT06392646

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yan Xue

Wuxi, Jiangsu, 214001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

self-management education program

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Wuxi No. 2 People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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