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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Zhejiang
      • Huzhou, Zhejiang, China, 313000
        • Huzhou University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The intervention group
The intervention group received the HET-based intervention program for 12 weeks.
Behavioral: The Health Empowerment Theory (HET) program
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
Active Comparator: routine community care
The control group received routine community care for 12 weeks.
Behavioral: routine community care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TianLe Xiang

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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