Clinical trial NCT05390931: Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes
Official title: The Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes in Essential Hypertension Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Motivational Interview
Cardiovascular Disease Risk
Healthy Lifestyle Behavior
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline Systolic and Diastolic Blood Pressure at 3 months
timeFrame: 3rd month
measure: Change from Baseline Systolic and Diastolic Blood Pressure at 6 months
timeFrame: 6th month
measure: Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 3 months
timeFrame: 3rd month
measure: Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 6 months
timeFrame: 6th month
measure: Change from Baseline Healthy Lifestyle Behaviors at 6 months
timeFrame: 6th month
Secondary outcomes:
measure: Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months
timeFrame: 3rd month
measure: Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months
timeFrame: 6th month
measure: Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 3 months
timeFrame: 3rd month
measure: Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 6 months
timeFrame: 6th month
measure: Change from Baseline Motivation Level, Behavior Level and Self-efficacy Level in Hypertension Self-care at 6 months
timeFrame: 6th month
measure: Change from Baseline Compliance Level for Hypertension Treatment at 6 months
timeFrame: 6th month
measure: Change from Baseline Physical Activity Level at 6 months
timeFrame: 6th month
measure: Change from Baseline Life Quality at 6 months
timeFrame: 6th month
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Işıklar Family Health Center
state: Tepebaşı
Study officials:
affiliation: Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
name: Pınar Duru, PhD
role: PRINCIPAL_INVESTIGATOR
References: