Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes

NCT ID: NCT05390931

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-31

Brief Summary

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The primary aim of this study is to determine the effects of education and motivational interviews structured according to the health belief model on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis. The secondary aim of the study is to determine the effects of the variables that mediate the probability of performing primary prevention measures according to the health belief model of patients with a diagnosis of essential hypertension. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 6-month follow-up period. The research will be carried out at Işıklar Family Health Center located in Eskişehir city center in Turkey. The study population of this research consists of 659 patients with a diagnosis of essential hypertension, aged between 30-59 years, registered in Işıklar Family Health Center. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 80 individuals, 40 in each group, with an increase of 20%, will form the research group. The research data collection process will be carried out in 4 stages. First of all, the data required to query the inclusion criteria and exclusion criteria for participant admission to the study will be evaluated using the "Data form for participant admission". For the other stages of the research data collection process; "Pre-test (Beginning at 0 months)", "Intermediate follow-up test (Follow-up at 3 months)" and "Posttest (6 months)" will be administered to the participants in the study and control groups by the researcher. In this study, "Cardiovascular Disease Risk Awareness Assessment Scale", "Cardiovascular Diseases Risk Factors Knowledge Level", "Framingham Cardiovascular Risk Score", "Healthy Lifestyle Behaviors Scale-II", "Hypertension Self-Care Profile", "Hill- Bone Hypertension Treatment Adherence Scale", "Physical Activity Questionnaire for Primary Care" and "SF-12 Quality of Life Scale" will be used as data collection tools. In addition to their routine care, the control group will be given a health education structured according to the health belief model and a training booklet on healthy lifestyle behavior changes at the end of the training.

Detailed Description

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Hypertension plays an important role in the early death of 1 in 4 men and 1 in 5 women (more than one billion people) diagnosed with hypertension worldwide. Hypertension, the prevalence which can vary from country to country, is around 30-45% of the general population, and this rate is observed to increase with age, which will continue to be an important public health problem today and in the future. Worldwide, only one out of every 5 adults (about 21%) has hypertension under control. It is seen that the risk of cardiovascular morbidity and mortality is higher in patients whose blood pressure cannot be controlled. It is important to control hypertension in order to prevent cardiovascular diseases (CVD), also patients should comply with their treatment and health recommendations.

Motivational interviewing is a client-centered communication technique that reveals the behavior change and desire for change by helping the person to understand the problem or problems arising from himself, to discover the problem, to discover and solve the ambivalence.In this study, it is thought that motivational interviews structured according to the health belief model can be effective on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis.

Conditions

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Essential Hypertension Motivational Interview Cardiovascular Disease Risk Healthy Lifestyle Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
In the study, participants will be left unaware of whether they are in the study or control group (single-blind masking).

Study Groups

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Study group

Study group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up.

Group Type EXPERIMENTAL

6-session motivational interviews

Intervention Type BEHAVIORAL

A total of 6 motivational interviews will be held once a month. Motivational interviews will be conducted individually.

Health education structured according to the health belief model

Intervention Type OTHER

After the participants enrolled in the study, the patients in the study group will be given a health education structured according to the health belief model at the first interview.

Training booklet prepared by the researchers on healthy lifestyle behavior changes

Intervention Type OTHER

After the participants enrolled in the study and take health education, a training booklet prepared by the researchers on healthy lifestyle behavior changes will be given to the participants.

6 month follow-up

Intervention Type OTHER

Follow-ups will be made 3 times in total, on the basis of pre-test, intermediate follow-up test (3 months), and post-test (6 months).

Control group

Control group intervention consists of a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and a 6-month follow-up.

Group Type OTHER

Health education structured according to the health belief model

Intervention Type OTHER

After the participants enrolled in the study, the patients in the study group will be given a health education structured according to the health belief model at the first interview.

Training booklet prepared by the researchers on healthy lifestyle behavior changes

Intervention Type OTHER

After the participants enrolled in the study and take health education, a training booklet prepared by the researchers on healthy lifestyle behavior changes will be given to the participants.

6 month follow-up

Intervention Type OTHER

Follow-ups will be made 3 times in total, on the basis of pre-test, intermediate follow-up test (3 months), and post-test (6 months).

Interventions

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6-session motivational interviews

A total of 6 motivational interviews will be held once a month. Motivational interviews will be conducted individually.

Intervention Type BEHAVIORAL

Health education structured according to the health belief model

After the participants enrolled in the study, the patients in the study group will be given a health education structured according to the health belief model at the first interview.

Intervention Type OTHER

Training booklet prepared by the researchers on healthy lifestyle behavior changes

After the participants enrolled in the study and take health education, a training booklet prepared by the researchers on healthy lifestyle behavior changes will be given to the participants.

Intervention Type OTHER

6 month follow-up

Follow-ups will be made 3 times in total, on the basis of pre-test, intermediate follow-up test (3 months), and post-test (6 months).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteer to participate in the research
* Those who are registered with any of the family physicians in the Family Health Center where the research will be conducted.
* Being in the age range of 30-59
* Having a physician-diagnosed essential hypertension
* Having estimated 10-year CHD risk ≥ 10% based on the Framingham risk score
* Being a literate

Exclusion Criteria

* Having a disease like coronary artery disease, heart failure, angina, myocardial infarction, cerebrovascular diseases, cancer, or kidney failure.
* Having a pacemaker
* Having a disease like chronic obstructive pulmonary disease, neurological disorder, or psychosis and schizophrenia with severe mental illness
* Has a learning disability or communication disability
* Being pregnant
* Being morbid obese (BMI ≥50 kg/m2)
Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Pınar Duru

Assistant Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pınar Duru, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey

Locations

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Işıklar Family Health Center

Eskişehir, Tepebaşı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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FirdesKomaç

Identifier Type: -

Identifier Source: org_study_id

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