Cardiovascular Disease Risk of Awareness

November 24, 2023 updated by: Serdar ulak, Necmettin Erbakan University

The Effect on Risk Awareness, Perception and Risk Factors of Motivational Interview-Based Cardiovascular Risk Reduction Program (CARDIOREP) in Taxi-Minibus Drivers: A Randomized Controlled Research

The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

Study Overview

Detailed Description

While 1/3 of premature deaths in individuals under the age of 70 in the world occur due to Cardiovascular Diseases (WHO 2022), circulatory system diseases are at the forefront with 36.76% according to the health statistics of the Ministry of Health in our country. It is necessary to raise awareness and gain healthy lifestyle behaviors in the prevention of cardiovascular diseases. The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Not having been diagnosed with cardiovascular disease.
  • Using a smartphone.
  • Agree to use the Google Fit App.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention/treatment
Health education, mobile applications, monitoring, Cardiovascular disease risk assessment

Cardiovascular disease risk assessment

Training and Consultancy Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. By using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the working hours of the participants.

Mobile Application To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.

Monitoring Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.

Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. Using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the participants' working hours.

To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.

Text Messages Week 2 "Tobacco use causes 6 million deaths in the world. The risk of death is reduced by 90% in those who stop using tobacco. Alcohol use causes damage to the heart muscle, arrhythmia, and stroke. For a healthy life, you should stay away from smoking and alcohol. ' Week 4 '' Inadequate physical activity increases the risk of death from all causes. Physical activity reduces the risk of hypertension, stroke, and depression. 30 minutes of moderate-intensity physical activity daily is recommended.

Week 6 "Adequate consumption of vegetables and fruits reduces the risk of cardiovascular disease. Saturated and trans fats increase the risk of cardiovascular disease. It is recommended to consume <5 g less per day to prevent cardiovascular diseases.

Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.
Active Comparator: Active group
Cardiovascular disease risk assessment

Cardiovascular disease risk assessment

Training and Consultancy Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. By using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the working hours of the participants.

Mobile Application To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.

Monitoring Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.

Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Disease Risk Awareness Rating Scale Scores
Time Frame: at the end of 0th, 6th, and 12th weeks
The scale form consists of 3 sub-dimensions and 21 items. The sub-dimensions consist of perceived heart attack and stroke risk, healthy eating intentions, perceived benefits and intentions to change. A maximum score of 64 and a minimum score of 0 can be obtained from the scale. A higher score on the scale and its sub-dimensions indicates an increased awareness of cardiovascular diseases.
at the end of 0th, 6th, and 12th weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk perception
Time Frame: at the end of 0th, 6th, and 12th weeks
Perceived cardiovascular disease risk in the next 10 years is questioned as low, moderate, high and very high.
at the end of 0th, 6th, and 12th weeks
International Physical Activity Questionnaire Scores
Time Frame: at the end of 0th, 6th, and 12th weeks
The international physical activity questionnaire (Short Form) consists of 7 questions. The questionnaire asks about the number of days of vigorous, moderate, mild physical activity in the last 7 days and how much of the day, and how much time is spent sitting in individuals who do not engage in physical activity. It provides the calculation of the energy expended by the activities in meters. A high score on the scale form indicates being active in physical activity.
at the end of 0th, 6th, and 12th weeks
Beck Anxiety Scale Scores
Time Frame: at the end of 0th, 6th, and 12th weeks
The scale form consists of 21 questions on a 4-point Likert scale (0=none, 3=seriously) about anxiety symptoms in the last one week.
at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
anthropometric measurements weight (Kilograms)
at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
anthropometric measurements height (meter)
at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
anthropometric measurements hip circumference (centimeters)
at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
anthropometric measurements waist circumference (centimeters)
at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
blood pressure (mmHg)
at the end of 0th, 6th, and 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NecmettinEU70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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