Cardiovascular DiseaseCMDsNCT06703151
To Understand the Self-care Ability of Farmers and Fishermen With CMDs (Hypertension, Heart Disease, Hyperlipidemia, Type 2 Diabetes), Whether They Are Aware of CMDs, Their Treatment Status, Treatment Effectiveness, and Their Ability to Describe Known and Practice the Self-care Content of CMDs.
A study testing CMDs (Cardiometabolic Diseases) Self-Care Manual in people with Cardiovascular Disease and Diabetes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This project will be based on nursing scholar Dorothea Orem's self-care theory, integrating the concept of the [life essential 8, LE8] proposed by the American Heart Association, as well as our team's recent research findings. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Diabetes, Hyperlipidemia
- What is being tested?
- CMDs (Cardiometabolic Diseases) Self-Care Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Dec 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Farmers and fishermen who have been diagnosed with CMDs
- Aged between 18 and 75 years old
- Able to take care of their own daily life and can walk to the unit or community activity center that cooperates with this project
- Can communicate with Taiwanese and Mandarin, and agree to participate in the second and third years of this study
Who cannot join
- Those who have no household registration or live in an unstable place in the study area
- Those who have had a stroke or myocardial infarction
- Those who have kidney and heart failure diseases and have limited water intake
- Those who have cognitive or mental disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Mailiao, Yun Lin Hsien, 63861
Tung-Jung Huang, Dean, 05-6915151, donaldhuang@cgmh.org.tw
About this study
Official title: The Benefits of Improving Self-care Ability for Farmers and Fishermen With Existing Cardiometabolic Diseases
This project will be based on nursing scholar Dorothea Orem's self-care theory, integrating the concept of the [life essential 8, LE8] proposed by the American Heart Association, as well as our team's recent research findings. We aim to develop educational materials and tools tailored for this group, termed [Self-Care Eight Essentials] aligning with these theories and previous research outcomes. This study aims to present an overview of self-care abilities among farmers and fishermen with cardiovascular and metabolic diseases, identifying the distance from the ideal level and related influencing factors. It intends to establish self-care educational materials and tools tailored to the socioeconomic background of this specific population. Additionally, the study aims to transform these materials into tabletop game educational tools that possess credibility, effectiveness, and an element of entertainment. Through patents and technology transfer, these tools are expected to serve as convenient and effective guidance instruments for health bureaus and primary healthcare units.
Read the detailed description
Research background: In addition to emphasizing three-stage and five-level prevention strategies, community nursing is also expected to demonstrate innovative capabilities and initiatives in health equality and climate change response in sustainable development. Agriculture and aquaculture are an important development of the country, the foundation of people's life and ecological conservation; Taiwan's southwestern coast is an important base for providing high-quality agricultural and fishery products to the people, accounting for one-third of the households and people engaged in agriculture and fishery in the country. However, with international economic and trade pressures and climate change, the number of these farmers and fishermen is decreasing year by year as they face declining production capacity and income. According to the preliminary research results of our team, the prevalence and mortality rate of cardiometabolic diseases among farmers and fishermen along the southwestern coast are higher than those in the country and advanced countries in Europe and the United States. At the same time, the rate of chronic dehydration is also high. Overall farmers and fishermen have low education levels, are aging, and lack medical resources. Relatively inadequate. Literature shows that if people with cardiometabolic diseases improve their self-care abilities, they can avoid health deterioration such as myocardial infarction and stroke. From the perspective of assisting the sustainable development of agriculture and fisheries, how to overcome the health inequalities caused by social factors determining health? Through The focus of this project is to provide innovative strategies that are consistent with their socio-economic background and to effectively improve their self-care abilities and chronic dehydration problems. In the past, our team has gradually reduced the incidence of liver cancer and other related cancers in the region through the detection, referral and treatment of type C virus hepatitis with a high prevalence in the region. It has also provided the Ministry of Agriculture with relevant health needs and policy initiatives for farmers and fishermen, and has gained a lot of popularity. The trust and attention of relevant units will help us continue to promote cross-domain cooperation. So far, there is a lack of relevant literature at home and abroad to explore and improve the health problems of farmers and fishermen; there is even less research on community nursing to prevent and improve the worsening of cardiometabolic diseases.
Research purpose: Therefore, this project will be based on the results of previous research to conduct the following discussions: (1) the self-care ability of farmers and fishermen with cardiometabolic diseases; (2) designing a design that is consistent with the socio-economic background of farmers and fishermen to improve their self-care Ability teaching materials and teaching aids; (3) Verify the effectiveness of this teaching materials, teaching aids and the experimental design of this study, as a basis for industry-university cooperation with local governments and private enterprises, in order to achieve the influence of benefit diffusion.
Research methods and objects: This project will be based on the self-care theory of nursing scholar Dorothea Orem, combined with the concept of the eight key elements of life [life essential 8, LE8] proposed by the American Heart Association, and the research results of our team in recent years, to construct a structure that is suitable for this group Teaching materials and teaching aids for [Self-care - Octathlon]. This project is expected to be completed in three years. In the first year, a cross-sectional descriptive research method will be used to target farmers and fishermen on the southwest coast. It will cooperate with the Health Bureau and regional hospitals to identify farmers and fishermen with existing cardiometabolic diseases and carry out self-care. To discuss ability, chronic dehydration and its influencing factors, the sample size is estimated to be approximately 338 people. The research methods and purposes in the second to third years are: (1) Complete [board game] teaching aids that meet the socio-economic and cultural background needs of farmers and fishermen, and train seed teachers; (2) Community-based quasi-experimental research design, select Participants in the conditions were randomly assigned to the intervention group and the control group in clusters. Participants in both groups received the [Self-Care-8thlon-SC-8] teaching materials; the intervention group also received the [SC-8-Monopoly Board Game] program. After adopting the conventional community care model with the control group, the differences in self-care ability, cardiometabolic and inflammatory indicators are estimated to be approximately 205 in both groups at this stage. Use descriptive and inferential statistical analysis, such as chi-square and variance tests, multivariable linear, logistic regression and generalized estimating equations, to process repeated measurement data and adjust the effects of influencing factors.
Analysis: The study will employ both descriptive and inferential statistical analyses, such as chi-square and analysis of variance (ANOVA), multivariate linear regression, logistic regression, and generalized estimating equations (GEE) to handle repeated measures data and adjust for the effects of influencing factors.
Expected results: This study will be able to present an overview of the self-care ability of farmers and fishermen with cardiovascular and metabolic diseases, as well as the distance from ideal and related influencing factors, establish self-care teaching materials and teaching aids suitable for the socio-economic background of this group, and transform it into a reliable Through the completion of patents and technology transfer, the [board game] teaching aids with validity and entertaining functions are expected to be used as convenient and effective guidance tools for health bureaus and primary medical care units.
- Conditions
- Cardiovascular Disease, Diabetes, Hyperlipidemia, Stroke
- Being tested
- CMDs (Cardiometabolic Diseases) Self-Care Manual
- Keywords
- board game, sustainable development goals, climate change, reduced inequalities, cardiometabolic diseases, agriculture, aquaculture, self-care, dehydration status, inflammatory biomarkers
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Hyperlipidemias, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMDs (Cardiometabolic Diseases) Self-Care ManualBehavioural
1st-5th month: Complete the assessment of self-care ability and biochemical indicators, introduce the (CMDs self-care) teaching material manual, and evaluate the case's referral treatment status from the institution, and provide answers to questions. Played the Monopoly board game 8 times: On average, each community has about 2-3 groups (a group of 4-7 people), each group has a leader (seed teacher) to conduct CMDs health education Q\&A before each board game activity . 6th month: Conduct self-care process assessment in each community. 7th-12th month: Telephone visits are provided every 2 months (3 times in total), each case lasts 5-10 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group will have (CMDs self-care) teaching material and a [Monopoly board game] plan | Experimental | 1st-5th month: Complete the assessment of self-care ability and biochemical indicators, introduce the (CMDs self-care) teaching material manual, and evaluate the case's referral treatment status from the institution, and provide answers to questions. Played the Monopoly board game 8 times: On average, each community has about 2-3 groups (a group of 4-7 people), each group has a leader (seed teacher) to provide CMDs health education Q\&A before each board game activity . The 6th month: Conduct self-care process assessment in each community. The 7th-12th month: Telephone visits are provided every 2 months (3 times in total), each case lasts 5-10 minutes each time. Receives: Behavioral: CMDs (Cardiometabolic Diseases) Self-Care Manual |
| Only follow the community screening abnormality handling process and accept the referral treatment | No intervention | After completing the assessment of self-care ability and biochemical indicators, use the referral treatment and care model of the health center or cooperative hospital; provide self-care manuals to each community in the first to second months, and providing answers to questions (same as the experimental group); conduct self-care process assessments in each community in the 24th week |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of participants who can reduce cardiometabolic risks through enhancing CMDs self-care ability
Conducting CMDs' self-care health education intervention to evaluate participants' health-related behaviour changes and cardiometabolic risks reduction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start2 Dec 2024
- Primary completion20 Feb 2025 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The 1st year will involve a cross-sectional descriptive study targeting farmers and fishermen in the southwest coastal regions. Collaborating with the local health bureau and regional hospitals. It will investigate their self-care abilities, chronic dehydration, and associated influencing factors. The estimated samples are approximately 338 individuals. The research methods for the 2nd and 3rd years involve: (1) Developing a tabletop game educational tool tailored to the socioeconomic and cultural needs of farmers and fishermen, and training designated educators; (2) Employing a community-based quasi-experimental research design. Eligible participants will be cluster-randomized into intervention and control groups. Both groups will receive educational materials. The intervention group will additionally engage with the \[SC-8 Monopoly-style board game\] intervention, while the control group will only follow the regular community care model.
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Yen, Chen, Chang Gung Memorial Hospital
- Investigators
- Mei-Yen Chen, Distinguished Professor, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703151
- Sponsor's protocol ID
- IRB 202301844B0
- Other IDs
- MOST 113-2314-B-255-002-MY3
- Acronym
- CMDs
- Status last verified
- Feb 2025
- First submitted
- 18 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Before share IPD, we want to wait until this study is actually implemented and has concreted physical results.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Improving Self-care Ability for Farmers and Fishermen With Existing Cardiometabolic Diseases
- ClinicalTrials.gov ID
- NCT06703151
- Acronym / sponsor ID
- CMDs / IRB 202301844B0
- Conditions
- Cardiovascular Disease, Diabetes, Hyperlipidemia, Stroke
- Keywords
- board game, sustainable development goals, climate change, reduced inequalities, cardiometabolic diseases, agriculture, aquaculture, self-care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Nov 2024 (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 project will be based on nursing scholar Dorothea Orem's self-care theory, integrating the concept of the [life essential 8, LE8] proposed by the American Heart Association, as well as our team's recent research findings. We aim to develop educational materials and tools tailored for this group, termed [Self-Care Eight Essentials] aligning with these theories and previous research outcomes. This study aims to present an overview of self-care abilities among farmers and fishermen with cardiovascular and metabolic diseases, identifying the distance from the ideal level and related influencing factors. It intends to establish self-care educational materials and tools tailored to the socioeconomic background of this specific population. Additionally, the study aims to transform these materials into tabletop game educational tools that possess credibility, effectiveness, and an element of entertainment. Through patents and technology transfer, these tools are expected to serve as convenient and effective guidance instruments for health bureaus and primary healthcare units.
Detailed description
Research background: In addition to emphasizing three-stage and five-level prevention strategies, community nursing is also expected to demonstrate innovative capabilities and initiatives in health equality and climate change response in sustainable development. Agriculture and aquaculture are an important development of the country, the foundation of people's life and ecological conservation; Taiwan's southwestern coast is an important base for providing high-quality agricultural and fishery products to the people, accounting for one-third of the households and people engaged in agriculture and fishery in the country. However, with international economic and trade pressures and climate change, the number of these farmers and fishermen is decreasing year by year as they face declining production capacity and income. According to the preliminary research results of our team, the prevalence and mortality rate of cardiometabolic diseases among farmers and fishermen along the southwestern coast are higher than those in the country and advanced countries in Europe and the United States. At the same time, the rate of chronic dehydration is also high. Overall farmers and fishermen have low education levels, are aging, and lack medical resources. Relatively inadequate. Literature shows that if people with cardiometabolic diseases improve their self-care abilities, they can avoid health deterioration such as myocardial infarction and stroke. From the perspective of assisting the sustainable development of agriculture and fisheries, how to overcome the health inequalities caused by social factors determining health? Through The focus of this project is to provide innovative strategies that are consistent with their socio-economic background and to effectively improve their self-care abilities and chronic dehydration problems. In the past, our team has gradually reduced the incidence of liver cancer and other related cancers in the region through the detection, referral and treatment of type C virus hepatitis with a high prevalence in the region. It has also provided the Ministry of Agriculture with relevant health needs and policy initiatives for farmers and fishermen, and has gained a lot of popularity. The trust and attention of relevant units will help us continue to promote cross-domain cooperation. So far, there is a lack of relevant literature at home and abroad to explore and improve the health problems of farmers and fishermen; there is even less research on community nursing to prevent and improve the worsening of cardiometabolic diseases.
Research purpose: Therefore, this project will be based on the results of previous research to conduct the following discussions: (1) the self-care ability of farmers and fishermen with cardiometabolic diseases; (2) designing a design that is consistent with the socio-economic background of farmers and fishermen to improve their self-care Ability teaching materials and teaching aids; (3) Verify the effectiveness of this teaching materials, teaching aids and the experimental design of this study, as a basis for industry-university cooperation with local governments and private enterprises, in order to achieve the influence of benefit diffusion.
Research methods and objects: This project will be based on the self-care theory of nursing scholar Dorothea Orem, combined with the concept of the eight key elements of life [life essential 8, LE8] proposed by the American Heart Association, and the research results of our team in recent years, to construct a structure that is suitable for this group Teaching materials and teaching aids for [Self-care - Octathlon]. This project is expected to be completed in three years. In the first year, a cross-sectional descriptive research method will be used to target farmers and fishermen on the southwest coast. It will cooperate with the Health Bureau and regional hospitals to identify farmers and fishermen with existing cardiometabolic diseases and carry out self-care. To discuss ability, chronic dehydration and its influencing factors, the sample size is estimated to be approximately 338 people. The research methods and purposes in the second to third years are: (1) Complete [board game] teaching aids that meet the socio-economic and cultural background needs of farmers and fishermen, and train seed teachers; (2) Community-based quasi-experimental research design, select Participants in the conditions were randomly assigned to the intervention group and the control group in clusters. Participants in both groups received the [Self-Care-8thlon-SC-8] teaching materials; the intervention group also received the [SC-8-Monopoly Board Game] program. After adopting the conventional community care model with the control group, the differences in self-care ability, cardiometabolic and inflammatory indicators are estimated to be approximately 205 in both groups at this stage. Use descriptive and inferential statistical analysis, such as chi-square and variance tests, multivariable linear, logistic regression and generalized estimating equations, to process repeated measurement data and adjust the effects of influencing factors.
Analysis: The study will employ both descriptive and inferential statistical analyses, such as chi-square and analysis of variance (ANOVA), multivariate linear regression, logistic regression, and generalized estimating equations (GEE) to handle repeated measures data and adjust for the effects of influencing factors.
Expected results: This study will be able to present an overview of the self-care ability of farmers and fishermen with cardiovascular and metabolic diseases, as well as the distance from ideal and related influencing factors, establish self-care teaching materials and teaching aids suitable for the socio-economic background of this group, and transform it into a reliable Through the completion of patents and technology transfer, the [board game] teaching aids with validity and entertaining functions are expected to be used as convenient and effective guidance tools for health bureaus and primary medical care units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The 1st year will involve a cross-sectional descriptive study targeting farmers and fishermen in the southwest coastal regions. Collaborating with the local health bureau and regional hospitals. It will investigate their self-care abilities, chronic dehydration, and associated influencing factors. The estimated samples are approximately 338 individuals. The research methods for the 2nd and 3rd years involve: (1) Developing a tabletop game educational tool tailored to the socioeconomic and cultural needs of farmers and fishermen, and training designated educators; (2) Employing a community-based quasi-experimental research design. Eligible participants will be cluster-randomized into intervention and control groups. Both groups will receive educational materials. The intervention group will additionally engage with the [SC-8 Monopoly-style board game] intervention, while the control group will only follow the regular community care model.
| Arm | Type | Receives |
|---|---|---|
| The experimental group will have (CMDs self-care) teaching material and a [Monopoly board game] plan | Experimental | Behavioral: CMDs (Cardiometabolic Diseases) Self-Care Manual1st-5th month: Complete the assessment of self-care ability and biochemical indicators, introduce the (CMDs self-care) teaching material manual, and evaluate the case's referral treatment status from the institution, and provide answers to questions. Played the Monopoly board game 8 times: On average, each community has about 2-3 groups (a group of 4-7 people), each group has a leader (seed teacher) to provide CMDs health education Q\&A before each board game activity . The 6th month: Conduct self-care process assessment in each community. The 7th-12th month: Telephone visits are provided every 2 months (3 times in total), each case lasts 5-10 minutes each time. |
| Only follow the community screening abnormality handling process and accept the referral treatment | No intervention | –After completing the assessment of self-care ability and biochemical indicators, use the referral treatment and care model of the health center or cooperative hospital; provide self-care manuals to each community in the first to second months, and providing answers to questions (same as the experimental group); conduct self-care process assessments in each community in the 24th week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Farmers and fishermen who have been diagnosed with CMDs
- Aged between 18 and 75 years old
- Able to take care of their own daily life and can walk to the unit or community activity center that cooperates with this project
- Can communicate with Taiwanese and Mandarin, and agree to participate in the second and third years of this study
Key exclusion criteria (4 listed)
- Those who have no household registration or live in an unstable place in the study area
- Those who have had a stroke or myocardial infarction
- Those who have kidney and heart failure diseases and have limited water intake
- Those who have cognitive or mental disorders
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 |
|---|---|---|
| CMDs (Cardiometabolic Diseases) Self-Care Manual1st-5th month: Complete the assessment of self-care ability and biochemical indicators, introduce the (CMDs self-care) teaching material manual, and evaluate the case's referral treatment status from the institution, and provide answers to questions. Played the Monopoly board game 8 times: On average, each community has about 2-3 groups (a group of 4-7 people), each group has a leader (seed teacher) to conduct CMDs health education Q\&A before each board game activity . 6th month: Conduct self-care process assessment in each community. 7th-12th month: Telephone visits are provided every 2 months (3 times in total), each case lasts 5-10 minutes each time. | Behavioural | The experimental group will have (CMDs self-care) teaching material and a [Monopoly board game] plan |
Primary outcome
The Number of participants who can reduce cardiometabolic risks through enhancing CMDs self-care ability
Time frame: 12 months
Conducting CMDs' self-care health education intervention to evaluate participants' health-related behaviour changes and cardiometabolic risks reduction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Report on rural household registration sampling survey in TaiwanLink provided by the sponsor.
- Ministry of Health and Welfare.Guidelines for preventive care of cardiovascular disease.Link provided by the sponsor.
- Health Promotion Administration. Metabolic syndrome.Link provided by the sponsor.
- United Nations (2023). Transforming our world: the 2030 agenda for sustainable development goals.Link provided by the sponsor.
- WHO guideline on self-care interventions for health and well-being.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Before share IPD, we want to wait until this study is actually implemented and has concreted physical results.
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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.
Mei-Yen Chen, Distinguished Professor principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMDs (Cardiometabolic Diseases) Self-Care Manual in people with Cardiovascular Disease and Diabetes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Feb 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei-Yen Chen, Distinguished Professor (886-5-3628800 ext. 2301, meiyen@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of participants who can reduce cardiometabolic risks through enhancing CMDs self-care ability (time frame: 12 months). 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 12 Feb 2025.