The Effect of Interventions for Health Behaviors in Hypertensive Patients

November 19, 2024 updated by: Yuan He, Nanjing Medical University

The Effect of Interventions for Health Behaviors in Hypertensive Patients -Based on the PRECEDE-PROCEED Model

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Community health service center
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
No Intervention: Control
During the study, control participant will be provided with existing community health education on hypertension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health behavior
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge of hypertension
Time Frame: 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)
Self-compiled questionnaire. It consisted of 16 binary items. A score of 1 was given for each correct answer, and a score of 0 was given for incorrect and "don't know" replies for each question, with a higher score reflecting a better outcome.
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
Time Frame: 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)
The questionnaire of reinforcing factors will be designed based on the precede - proceed model. Each item is rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree), with a higher score reflecting a better outcome.
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
Time Frame: 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)
The questionnaire of enabling factors will be designed based on the precede - proceed model. Each item is rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree), with a higher score reflecting a better outcome.
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
Time Frame: 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)
the Chinese version of the Perceived Health Competence Scale (PHCS). Each item is rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5(strongly agree), with a higher score reflecting a better outcome. 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)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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