Health Self-managementNCT06914739
Application of Health Empowerment Theory to Enhance Health Empowerment Levels and Self-Health Management Ability Among Older Migrants: A Randomized Controlled Trial
A study testing The Health Empowerment Theory (HET) program and routine community care in people with Health Self-management, run by TianLe Xiang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Health Self-management
- What is being tested?
- The Health Empowerment Theory (HET) program and routine community care
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2021to 12 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (1) absencefrom two consecutive lectures or group activities without prior notification and (2) voluntary withdrawal from the study at the participant's request.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health Self-management
- Being tested
- The Health Empowerment Theory (HET) program, routine community care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Health Empowerment Theory (HET) programBehavioural
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
routine community careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | The intervention group received the HET-based intervention program for 12 weeks. Receives: Behavioral: The Health Empowerment Theory (HET) program |
| routine community care | Active comparator | The control group received routine community care for 12 weeks. Receives: Behavioral: routine community care |
What is being measured
The primary outcome is the main question the study is designed to answer.
health empowerment level
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
self-health management ability
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start12 Mar 2021
- Primary completion8 Feb 2022
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Self-managementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- TianLe Xiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, TianLe Xiang, Huzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914739
- Sponsor's protocol ID
- 2022011
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Health Empowerment Theory to Enhance Health Empowerment Levels and Self-Health Management Ability Among Older Migrants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06914739
- Acronym / sponsor ID
- 2022011
- Conditions
- Health Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- TianLe XiangUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: The Health Empowerment Theory (HET) programThe intervention group received the HET-based intervention program for 12 weeks. |
| routine community care | Active comparator | Behavioral: routine community careThe control group received routine community care for 12 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (1) absencefrom two consecutive lectures or group activities without prior notification and (2) voluntary withdrawal from the study at the participant's request.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Health Empowerment Theory (HET) programThe 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 | Behavioural | The intervention group |
| routine community careThe 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. | Behavioural | routine community care |
Primary outcome
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.
1 secondary outcome
self-health management ability
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Health Empowerment Theory (HET) program and routine community care in people with Health Self-management, run by TianLe Xiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health empowerment level (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.