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. (CMDs)

February 10, 2025 updated by: Mei-Yen, Chen, Chang Gung Memorial Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

338

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 Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Yun Lin Hsien
      • Mailiao, Yun Lin Hsien, Taiwan, 63861
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

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:

  • 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

Exclusion Criteria:

  • 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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group will have (CMDs self-care) teaching material and a [Monopoly board game] plan
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.
Behavioral: CMDs (Cardiometabolic Diseases) Self-Care Manual
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.
No Intervention: Only follow the community screening abnormality handling process and accept the referral treatment
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Mei-Yen Chen, Distinguished Professor, Chang Gung University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

December 2, 2024

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 202301844B0
  • MOST 113-2314-B-255-002-MY3 (Other Grant/Funding Number: National Science and Technology Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Before share IPD, we want to wait until this study is actually implemented and has concreted physical results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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