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NCT Number: NCT05390931

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Disease Risk Cardiovascular Diseases Healthy Lifestyle Behavior Hypertension Motivational Interview Vascular Diseases

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Işıklar Family Health Center

Eskişehir, Tepebaşı, 26120, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

6-session motivational interviews

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

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

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

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).

Primary outcomes

  1. Change from Baseline Systolic and Diastolic Blood Pressure at 3 months

    Time frame: 3rd month

    Systolic and diastolic blood pressure

  2. Change from Baseline Systolic and Diastolic Blood Pressure at 6 months

    Time frame: 6th month

    Systolic and diastolic blood pressure

  3. Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 3 months

    Time frame: 3rd month

    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.

  4. Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 6 months

    Time frame: 6th month

    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.

  5. Change from Baseline Healthy Lifestyle Behaviors at 6 months

    Time frame: 6th month

    "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.

Secondary outcomes

  1. Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months

    Time frame: 3rd month

    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.

  2. Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months

    Time frame: 6th month

    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.

  3. Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 3 months

    Time frame: 3rd month

    "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.

  4. Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 6 months

    Time frame: 6th month

    "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.

  5. Change from Baseline Motivation Level, Behavior Level and Self-efficacy Level in Hypertension Self-care at 6 months

    Time frame: 6th month

    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.

  6. Change from Baseline Compliance Level for Hypertension Treatment at 6 months

    Time frame: 6th month

    "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.

  7. Change from Baseline Physical Activity Level at 6 months

    Time frame: 6th month

    "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.

  8. Change from Baseline Life Quality at 6 months

    Time frame: 6th month

    "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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

The Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes in Essential Hypertension Patients: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 25, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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