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OpenTrials
Completed

NCT Number: NCT04656132

PAVS in Cardiology

Brief Summary This is a pilot study implemented physical activity assessment, promotion and monitoring in patients. Patients will be assessed by the physical activity vital sign (PAVS) during check-in for their appointment. During their visit with the cardiologist, a clinical decision support tool will alert the cardiologist to patients achieving low (<50% of recommended) physical activity. The cardiologist may refer the patient to cardiac rehabilitation if appropriate and/or counsel them to increase their physical activity levels. The patients may opt to enroll in the monitoring phase of the study. They will be given a Fitbit pedometer and their Fitbit account can sync to their MyChart account. After that sync, the patients step counts will be available for their cardiologists to review as needed.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU Langone

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients in the Center who are age 18 and above will be assessed with the PAVS as part of routine care. To enroll in the home monitoring of PA:

  • Patients must achieve < 50% of PA recommendations according to PAVS screening questions
  • Have a cellular phone with data plan or a computer to sync Fitbit data
  • Speak English or Spanish
  • Be willing to wear a Fitbit Zip for 3 months

Exclusion criteria

  • Adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. wheelchair bound, aortic stenosis, unstable angina)
  • Planned surgery within three months
  • Those with decisional incapacity therefore unable to comply with study requirements (i.e. related to cognitive deficits or psychiatric diagnosis)
  • Pregnant or breastfeeding women.

Treatment and study plan

Physical activity assessment, promotion and monitoring in a preventive cardiology clinic

Behavioral

physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center

Primary outcomes

  1. Step Counts

    Time frame: Month 3

    Pedometer

  2. BMI

    Time frame: Month 3

    BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.

  3. Waist Circumference

    Time frame: Month 3

    Waist Circumference will be measured to the nearest inch using standard technique

  4. Blood Pressure

    Time frame: Month 3

    Blood pressure (BP) will be measured in right arm (unless contraindicated) after sitting for 5 minutes and repeated after a 5-minute interval. Both will be recorded and the average used in analyses.

  5. Blood Lipid Levels

    Time frame: Month 3

    Total cholesterol, HDL, and triglycerides will be measured by CLIA-waived Alere Cholestech LDX® Analyzer which is certified by the Center for Disease Control's Lipid Standardization Program and Cholesterol Reference Method Laboratory Method Network. This will be measured by a single fingerstick using standard aseptic technique.

  6. Framingham Heart Study Risk Score

    Time frame: Month 3

    The Framingham Heart Study Risk Score (10-year risk) will be calculated using the appropriate risk model based on participants' age, gender, diabetes status and prior coronary heart disease. Risk is considered low if the FRS is less than 10%, moderate if it is 10% to 19%, and high if it is 20% or higher.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2020
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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