- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06914739
Application of Health Empowerment Theory to Enhance Health Empowerment Levels and Self-Health Management Ability Among Older Migrants: A Randomized Controlled Trial
March 31, 2025 updated by: TianLe Xiang
This study aimed to evaluate the effectiveness of a theory-based health self-management program in empowering older migrants to manage their health.
This study used a single-blind, randomized controlled trial design.
A comparison was conducted between the experimental and control groups in terms of pre-test and post-test levels of health empowerment and health self-management abilities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
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
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Zhejiang
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Huzhou, Zhejiang, China, 313000
- Huzhou University
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-
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:
- (1) age 60 years or older; (2) residing in thelocal area for a minimum of six months; (3) agreement to participate in the study and willingness tosign the informed consent form; and (4) possessing a clear sense of autonomy and the ability tounderstand and engage with the content of the study intervention activities.
Exclusion Criteria:
- (1) absencefrom two consecutive lectures or group activities without prior notification and (2) voluntary withdrawal from the study at the participant's request.
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The intervention group
The intervention group received the HET-based intervention program for 12 weeks.
|
The intervention group received the HET-based intervention program for 12 weeks.
From the first week to the fourth week, community nurses interacted with the participants face-to-face to analyze and establish their problems and needs in health management (usual community health services utilization, such as medicine purchases and vaccinations) and helped clarify the importance of health management and their strengths (such as existing health knowledge).
From the fifth to twelfth weeks, participants attended health knowledge lectures led by community nurses, covering topics such as: a) healthy lifestyle, primarily diet, exercise, and disease prevention and management for older adults; and b) community health services, which included recent or long-term community health services (such as health examinations for older adults and family doctor contracts).
WeChat groups and offline gatherings at community health centers (with groups of eight to ten peers) were organized to interact and comm
|
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Active Comparator: routine community care
The control group received routine community care for 12 weeks.
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The control group received routine community care, including notifications of community- related activities and lectures through WeChat group chats or telephone calls, and had questions answered by researchers and community nurses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
health empowerment level
Time Frame: From enrollment to the end of treatment at 12 weeks
|
The Older Health Empowerment Evaluation Scale comprises six subdimensions: liability beliefs, knowledge and skills, external support, participation in health management, acceptance of change, and empowerment of others.35
The scale consists of 38 items.
A Likert 5-point scoring method was employed, with a total score ranging from 38 to 190.
A high score indicates a high level of health empowerment among older adults.
The total Cronbach's α coefficient was 0.959, with the Cronbach's α coefficient of each dimension ranging from 0.827 to 0.890.
This scale was used to replace the chronic disease older health empowerment scale, mainly to better assess health empowerment in older adults and reflect subtle but significant differences in empowerment levels between the older groups.
|
From enrollment to the end of treatment at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-health management ability
Time Frame: From enrollment to the end of treatment at 12 weeks
|
The Adult Health Self-Management Skill Rating Scale is a widely used instrument for evaluating individual self-health management ability.36
The formal scale consists of three subscales with 38 items: the Health Self-Management Cognition subscale (14 items), Self-Management Environment subscale (10 items), and Health Self-Management Behavior subscale (14 items).
A Likert 5-point scoring method was employed, whereby a high score indicates a high level of health self-management ability.
A score of 36 to 76 indicates a low level of ability, 77 to 152 denotes a medium level, and 153 to 190 indicates a high level of ability.
The Cronbach's α coefficient of the scale was 0.993, and the content validity was 0.895.
|
From enrollment to the end of treatment at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 12, 2021
Primary Completion (Actual)
February 8, 2022
Study Completion (Actual)
February 12, 2022
Study Registration Dates
First Submitted
March 31, 2025
First Submitted That Met QC Criteria
March 31, 2025
First Posted (Actual)
April 6, 2025
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
March 31, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2022011
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
product manufactured in and exported from the U.S.
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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