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

NCT05390931 | Completed

• 1 other identifier: FirdesKomaç
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension; Motivational Interview; Cardiovascular Disease Risk; Healthy Lifestyle Behavior

Outcome Measures

Primary Outcomes (5)

• Change from Baseline Systolic and Diastolic Blood Pressure at 3 months

  Systolic and diastolic blood pressure

  3rd month

• Change from Baseline Systolic and Diastolic Blood Pressure at 6 months

  Systolic and diastolic blood pressure

  6th month

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

  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.

  3rd month

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

  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.

  6th month

• Change from Baseline Healthy Lifestyle Behaviors at 6 months

  "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.

  6th month

Secondary Outcomes (8)

• Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months

  3rd month

• Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months

  6th month

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

  3rd month

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

  6th month

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

  6th month

Study Arms (2)

Study group

EXPERIMENTAL

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.

Behavioral: 6-session motivational interviews; Other: Health education structured according to the health belief model; Other: Training booklet prepared by the researchers on healthy lifestyle behavior changes; Other: 6 month follow-up

Control group

OTHER

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.

Other: Health education structured according to the health belief model; Other: Training booklet prepared by the researchers on healthy lifestyle behavior changes; Other: 6 month follow-up

Interventions

6-session motivational interviews BEHAVIORAL

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

Study group

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.

Control group; Study group

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.

Control group; Study group

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).

Control group; Study group

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: In order for the assignments to the study and control groups to be made equally and homogeneously, 80 people in the study group will be determined by using the "stratified randomization" method, one of the randomization subgroups, according to the baseline risk factors in a balanced way in terms of the gender variable, which is one of the prognostic factors.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Işıklar Family Health Center

Eskişehir, Tepebaşı, 26120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pınar Duru, PhD

  Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the study, participants will be left unaware of whether they are in the study or control group (single-blind masking).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: August 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)