MedPath

PAVS in Cardiology

Phase 1
Completed
Conditions
Cardiovascular Diseases
Interventions
Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic
Registration Number
NCT04656132
Lead Sponsor
NYU Langone Health
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
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:

  1. Patients must achieve < 50% of PA recommendations according to PAVS screening questions
  2. Have a cellular phone with data plan or a computer to sync Fitbit data
  3. Speak English or Spanish
  4. Be willing to wear a Fitbit Zip for 3 months
Exclusion Criteria
  1. Adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. wheelchair bound, aortic stenosis, unstable angina)
  2. Planned surgery within three months
  3. Those with decisional incapacity therefore unable to comply with study requirements (i.e. related to cognitive deficits or psychiatric diagnosis)
  4. Pregnant or breastfeeding women.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Participants with cardiovascular disease or cardiovascular disease risk factorsPhysical activity assessment, promotion and monitoring in a preventive cardiology clinicPopulation We will recruit 59 males and females age \> 18 being seen in the NYU Langone Center for Prevention of Cardiovascular Disease (4F). Participants have cardiovascular disease or cardiovascular disease risk factors.
Primary Outcome Measures
NameTimeMethod
Waist CircumferenceMonth 3

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

Blood Lipid LevelsMonth 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.

Step CountsMonth 3

Pedometer

BMIMonth 3

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

Blood PressureMonth 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.

Framingham Heart Study Risk ScoreMonth 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

NYU Langone

🇺🇸

New York, New York, United States

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