The Effect of Interventions for Health Behaviors in Hypertensive Patients

NCT06640751 | Recruiting

• 1 other identifier: 2021378
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Health behavior

  Health behaviors associated with hypertensive patients, including treatment adherence, physical activity. Treatment adherence will be measured by the Chinese version of Hill-Bone compliance to high blood pressure therapy scale (HBTS). Each item is rated on a 4-point Likert scale, ranging from 1 (All the Time) to 4 (None of the Time), with a higher score reflecting a better outcome. Physical activity will be measured by the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ-SF is a self-administered questionnaire, which is used to measure individuals' physical activity during the last seven days. Participants were required to report the frequency and duration that they engaged in each intensity activity. The total score is the summation of the duration and frequency of walking, moderate-, and vigorous-intensity activities, which was reported as the "metabolic equivalent of task-min per week. This instrument has been widely used and well validated.

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)

• systolic blood pressure

  change in SBP between the intervention and control at 9 months

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)

• Delay discounting

  Self-written computer program. Discount rates from the delay discounting task were calculated with hyperbolic discounting model of the form: V= A/(1+kD). A higher value of k value indicates a greater discount for delayed rewards.

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)

Secondary Outcomes (4)

• Knowledge of hypertension

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month of the study)

• Reinforcing factors

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)

• Enabling factors

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)

• Self-efficacy

  1. Before the intervention: Baseline 2. During the intervention (at the end of the 3th, 6th month of the study) 3. the follow-up test (posttests - at the end of the 9th month)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Health behavior intervention

Control

NO INTERVENTION

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

Interventions

Health behavior intervention 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age greater than 18 years and less than 80 years;
• Normal language communication ability and willingness to participate in the study;
• Have lived in the community for at least 12 months.

You may not qualify if:

• Patients who lack basic behavioral abilities, have impaired memory function, or have limited language expression abilities;
• Patients who are simultaneously participating in other intervention studies.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Community health service center

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Yuan He, PhD

CONTACT

18651625286; heyuan@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)