The Effect of Interventions for Health Behaviors in Hypertensive Patients

NCT ID: NCT06640751

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-05-31

Brief Summary

Hypertension is a major risk factor for cardiovascular disease, chronic kidney disease, and premature death worldwide. With an aging population and changes in dietary patterns and lifestyles, the prevalence of hypertension is rising globally, especially in developing countries. Hypertension is the most common chronic disease and a growing public health problem in China. A recent study estimated the prevalence of hypertension to be 28.56 % ± 10.44 %, ranging from 14.28% to 44.28% among the Chinese population aged over 15 years. The PRECEED-PROCEDE model provides a framework to help health planners and policymakers design effective health interventions based on evaluation and analysis of situations. This model has been used in different recent studies related to behavioral change. The study aims to examine the effectiveness of interventions for health behaviors in hypertensive patients based on the PRECEDE-PROCEED model.

Conditions

Hypertension; Health Behavior; Public Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention group, based on the three core elements of the PROCEED model (predisposing, enabling, and reinforcing factors), aims to influence the health behaviors of patients with hypertension.

Group Type: EXPERIMENTAL

Health behavior intervention

Intervention Type: BEHAVIORAL

The program is a group-based intervention provided by a healthcare team consisting of researchers, cardiologists, family doctors, community healthcare workers, psychologists, and health education specialists. The intervention is structured around three modules-predisposing, enabling, and reinforcing factors-that provide a framework for educational interventions aimed at promoting healthy behaviors in hypertensive patients.

Control

During the study, control participant will be provided with existing community health education on hypertension.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health behavior intervention

The program is a group-based intervention provided by a healthcare team consisting of researchers, cardiologists, family doctors, community healthcare workers, psychologists, and health education specialists. The intervention is structured around three modules-predisposing, enabling, and reinforcing factors-that provide a framework for educational interventions aimed at promoting healthy behaviors in hypertensive patients.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with mild to moderate primary hypertension according to the diagnostic criteria of the "2018 Revised Edition of the Chinese Guidelines for the Prevention and Treatment of Hypertension," whose blood pressure is not well controlled or who have poor treatment compliance;

2. Age greater than 18 years and less than 80 years;

3. Normal language communication ability and willingness to participate in the study;

4. Have lived in the community for at least 12 months.

Exclusion Criteria

1. Patients who lack basic behavioral abilities, have impaired memory function, or have limited language expression abilities;

2. Patients who are simultaneously participating in other intervention studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuan He

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Community health service center

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan He, PhD

Role: CONTACT

heyuan@njmu.edu.cn

18651625286

Facility Contacts

Yuan He

Role: primary

heyuan@njmu.edu.cn

18651625286

Other Identifiers

2021378

Identifier Type: -

Identifier Source: org_study_id