NCT06392646

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

April 24, 2024

Last Update Submit

July 26, 2024

Conditions

Keywords

Enterostomyelderlyself-managementeducation

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 INTERVENTION

Taking routine care measures

self-management education program

EXPERIMENTAL

Intervention in accordance with the constructed self-management education program

Behavioral: self-management education program

Interventions

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

self-management education program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations