Cardiovascular DiseasesNCT06000436
Cardiovascular Disease Risk of Awareness
A study testing Cardiovascular disease risk assessment, Training and Consultancy and Mobile Application in people with Cardiovascular Diseases, run by Necmettin Erbakan University.
Trial summary
The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiovascular disease risk assessment, Training and Consultancy and Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not having been diagnosed with cardiovascular disease.
- Using a smartphone.
- Agree to use the Google Fit App.
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiovascular disease risk assessment, Training and Consultancy, Mobile Application, Monitoring
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular disease risk assessmentOther
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.
Training and ConsultancyOther
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.
Mobile ApplicationOther
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.
MonitoringOther
Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | Health education, mobile applications, monitoring, Cardiovascular disease risk assessment Receives: Other: Cardiovascular disease risk assessment; Other: Training and Consultancy; Other: Mobile Application; Other: Monitoring |
| Active group | Active comparator | Cardiovascular disease risk assessment Receives: Other: Cardiovascular disease risk assessment; Other: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Disease Risk Awareness Rating Scale Scores
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.
Measured: at the end of 0th, 6th, and 12th weeks
Secondary outcomes (8)
Cardiovascular risk perception
Perceived cardiovascular disease risk in the next 10 years is questioned as low, moderate, high and very high.
Measured: at the end of 0th, 6th, and 12th weeks
International Physical Activity Questionnaire Scores
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.
Measured: at the end of 0th, 6th, and 12th weeks
Beck Anxiety Scale Scores
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.
Measured: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
anthropometric measurements weight (Kilograms)
Measured: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
anthropometric measurements height (meter)
Measured: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
anthropometric measurements hip circumference (centimeters)
Measured: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
anthropometric measurements waist circumference (centimeters)
Measured: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
blood pressure (mmHg)
Measured: at the end of 0th, 6th, and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar ulak, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000436
- Sponsor's protocol ID
- NecmettinEU70
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06000436
- Acronym / sponsor ID
- NecmettinEU70
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Other: Cardiovascular disease risk assessment, Other: Training and Consultancy, Other: Mobile Application, Other: MonitoringHealth education, mobile applications, monitoring, Cardiovascular disease risk assessment |
| Active group | Active comparator | Other: Cardiovascular disease risk assessment, Other: MonitoringCardiovascular disease risk assessment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not having been diagnosed with cardiovascular disease.
- Using a smartphone.
- Agree to use the Google Fit App.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular disease risk assessmentCardiovascular 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. | Other | Active group, Intervention/treatment |
| Training and ConsultancyBased 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. | Other | Intervention/treatment |
| Mobile ApplicationTo 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. | Other | Intervention/treatment |
| MonitoringDaily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application. | Other | Active group, Intervention/treatment |
Primary outcome
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.
8 secondary outcomes
Cardiovascular risk perception
Time frame: 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
Beck Anxiety Scale Scores
Time frame: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time frame: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time frame: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time frame: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time frame: at the end of 0th, 6th, and 12th weeks
Cardiovascular disease risk factors
Time frame: at the end of 0th, 6th, and 12th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular disease risk assessment, Training and Consultancy and Mobile Application in people with Cardiovascular Diseases, run by Necmettin Erbakan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Disease Risk Awareness Rating Scale Scores (time frame: at the end of 0th, 6th, and 12th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.