NCT05390931

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

Completed NA Last updated 7 September 2023

What this trial tests

NA trial testing 6-session motivational interviews in Essential Hypertension in 80 participants. Completed in 31 March 2023.

Timeline

1 August 2022

Primary endpoint
31 October 2022

31 March 2023

Quick facts

Lead sponsor	Eskisehir Osmangazi University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	80
Start date	1 August 2022
Primary completion	31 October 2022
Estimated completion	31 March 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

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

Conditions studied

• Essential Hypertension — all drugs for Essential Hypertension →
• Motivational Interview — all drugs for Motivational Interview →
• Cardiovascular Disease Risk — all drugs for Cardiovascular Disease Risk →
• Healthy Lifestyle Behavior — all drugs for Healthy Lifestyle Behavior →

Sponsor

Eskisehir Osmangazi University

Who can join

Adults 30 to 59, any sex, with Essential Hypertension or Motivational Interview. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.