- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05390931
Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes
The Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes in Essential Hypertension Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tepebaşı
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Eskişehir, Tepebaşı, Turkey, 26120
- Işıklar Family Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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A total of 6 motivational interviews will be held once a month.
Motivational interviews will be conducted individually.
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.
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.
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).
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Other: 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.
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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.
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.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Systolic and Diastolic Blood Pressure at 3 months
Time Frame: 3rd month
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Systolic and diastolic blood pressure
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3rd month
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Change from Baseline Systolic and Diastolic Blood Pressure at 6 months
Time Frame: 6th month
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Systolic and diastolic blood pressure
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6th month
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Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 3 months
Time Frame: 3rd month
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The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score".
According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of <10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk.
The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%.
Persons with a 30-year risk score of < 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
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3rd month
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Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 6 months
Time Frame: 6th month
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The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score".
According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of <10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk.
The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%.
Persons with a 30-year risk score of < 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
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6th month
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Change from Baseline Healthy Lifestyle Behaviors at 6 months
Time Frame: 6th month
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"Healthy Lifestyle Behaviors Scale II" will be used to determine the healthy lifestyle behavior changes of the participants.
A minimum of 52 and a maximum of 208 points can be obtained from the scale.
Increasing scores from the scale indicate that individuals develop positive healthy lifestyle behaviors.
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6th month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months
Time Frame: 3rd month
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The "Cardiovascular Disease Risk Awareness Assessment Scale" will be used to evaluate the awareness of individuals with a diagnosis of essential hypertension about the risks associated with cardiovascular diseases.
A minimum of 14 and a maximum of 56 points can be obtained from the scale.
The higher scores obtained from the scale, the higher the awareness of cardiovascular diseases.
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3rd month
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Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months
Time Frame: 6th month
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The "Cardiovascular Disease Risk Awareness Assessment Scale" will be used to evaluate the awareness of individuals with a diagnosis of essential hypertension about the risks associated with cardiovascular diseases.
A minimum of 14 and a maximum of 56 points can be obtained from the scale.
The higher scores obtained from the scale, the higher the awareness of cardiovascular diseases.
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6th month
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Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 3 months
Time Frame: 3rd month
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"Cardiovascular Diseases Risk Factors Knowledge Level" will be used to determine the knowledge level of the participants on cardiovascular disease risk factors.
The highest total score that can be obtained from the scale is 28, and the higher score, the higher the level of knowledge.
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3rd month
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Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 6 months
Time Frame: 6th month
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"Cardiovascular Diseases Risk Factors Knowledge Level" will be used to determine the knowledge level of the participants on cardiovascular disease risk factors.
The highest total score that can be obtained from the scale is 28, and the higher score, the higher the level of knowledge.
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6th month
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Change from Baseline Motivation Level, Behavior Level and Self-efficacy Level in Hypertension Self-care at 6 months
Time Frame: 6th month
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The "Hypertension Self-Care Profile" will be used to evaluate the behavior change, motivation, and confidence levels of the participants in hypertension self-care related to lifestyle changes, and drug compliance.
The hypertension self-care profile has three sub-dimensions: "Behavior", "Motivation" and "Self-efficacy".
Each of the three sub-dimensions is scored separately, resulting in scores ranging from 20 to 80. Increased scores from the scale represent better self-care for a patient with hypertension.
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6th month
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Change from Baseline Compliance Level for Hypertension Treatment at 6 months
Time Frame: 6th month
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"Hill-Bone Compliance to High Blood Pressure Therapy Scale" will be used to evaluate the compliance level of the participants to hypertension treatment.
A minimum score of 0 and a maximum score of 42 can be obtained from the scale, and a score of 0 indicates perfect compliance with treatment.
A high total score on the scale indicates a decrease in compliance with treatment.
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6th month
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Change from Baseline Physical Activity Level at 6 months
Time Frame: 6th month
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"Physical Activity Questionnaire for Primary Care" will be used to evaluate the physical activity levels of the participants.
The scale is applied to individuals between the ages of 16-74 and gives results at four levels: active, moderately active, less active and inactive.
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6th month
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Change from Baseline Life Quality at 6 months
Time Frame: 6th month
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"SF-12 Quality of Life Scale" will be used to evaluate the quality of life of the participants.
Both the physical component summary score and the mental component summary score range from 0-to 100.
A higher score is indicative of better health.
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6th month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pınar Duru, PhD, Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FirdesKomaç
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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