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.

NCT06703151 | Recruiting DMC

• 2 other identifiers: IRB 202301844B0MOST 113-2314-B-255-002-MY3
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Disease; Diabetes; Hyperlipidemia; Stroke

Keywords

board game; sustainable development goals; climate change; reduced inequalities; cardiometabolic diseases; agriculture; aquaculture; self-care; dehydration status; inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

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.

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

Interventions

CMDs (Cardiometabolic Diseases) Self-Care Manual BEHAVIORAL

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.

The experimental group will have (CMDs self-care) teaching material and a [Monopoly board game] plan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Mailiao, Yun Lin Hsien, 63861, Taiwan

RECRUITING

Related Links

• Report on rural household registration sampling survey in Taiwan
• Ministry of Health and Welfare.Guidelines for preventive care of cardiovascular disease.
• Health Promotion Administration. Metabolic syndrome.
• United Nations (2023). Transforming our world: the 2030 agenda for sustainable development goals.
• WHO guideline on self-care interventions for health and well-being.

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Hyperlipidemias; Stroke

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Mei-Yen Chen, Distinguished Professor

  Chang Gung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Yen Chen, Distinguished Professor

CONTACT

886-5-3628800; meiyen@mail.cgust.edu.tw

Yu-Ju Hou, Research Assistant

CONTACT

886-5-3628800; sigridho@mail.cgust.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Structured and semi-structured questionnaires: Basic social demographics and health history: age, gender, education level, occupational profile, living status, height, weight, and whether there are chronic diseases diagnosed by a physician, stroke, cancer or immune system-related diseases, etc., current treatment status (treatment method, home implementation overview, treatment institution), how effective the treatment is (biochemical indicators: such as blood pressure, blood sugar, blood lipids); whether there are professionals from medical institutions Provide health information related to personal diseases, such as drug precautions (time, dosage, usage), basic simple home instrument measurements (such as blood pressure monitors, blood glucose machines, weight scales), and self-care related information obtained by patients from medical institutions, weight loss methods and other information (such as diet, calories, exercise, drugs).
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: December 2, 2024
• Primary Completion: February 20, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)