NCT06000436

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable cardiovascular-diseases

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

July 19, 2023

Last Update Submit

November 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    at the end of 0th, 6th, and 12th weeks

Secondary Outcomes (8)

  • Cardiovascular risk perception

    at the end of 0th, 6th, and 12th weeks

  • International Physical Activity Questionnaire Scores

    at the end of 0th, 6th, and 12th weeks

  • Beck Anxiety Scale Scores

    at the end of 0th, 6th, and 12th weeks

  • Cardiovascular disease risk factors

    at the end of 0th, 6th, and 12th weeks

  • Cardiovascular disease risk factors

    at the end of 0th, 6th, and 12th weeks

  • +3 more secondary outcomes

Study Arms (2)

Intervention/treatment

EXPERIMENTAL

Health education, mobile applications, monitoring, Cardiovascular disease risk assessment

Other: Cardiovascular disease risk assessmentOther: Training and ConsultancyOther: Mobile ApplicationOther: Monitoring

Active group

ACTIVE COMPARATOR

Cardiovascular disease risk assessment

Other: Cardiovascular disease risk assessmentOther: Monitoring

Interventions

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.

Active groupIntervention/treatment

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.

Intervention/treatment

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.

Intervention/treatment

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

Active groupIntervention/treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 21, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share