PAVS in Cardiology

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with cardiovascular disease or cardiovascular disease risk factors<br>Population 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. | Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic<br>* physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step-counts | Pedometer | 3 months | 
| BMI | BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale. | 3 months | 
| waist circumference | Waist Circumference will be measured to the nearest inch using standard technique | 3 months | 
| blood pressure | 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. | 3 months | 
| blood lipid levels | 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. | 3 months | 
| Framingham Heart Study Risk Score | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the The Practical, Robust Implementation and Sustainability Model (PRISM) | The PRISM26 will be used to collect process evaluation data throughout the implementation. This will include data on the reach (proportion that participate in intervention), efficacy (success rate if implemented as designed), adoption (proportion that adopt intervention), implementation (extent to which intervention is implemented as intended) and maintenance (extent to which program is sustained over time) of the PA promotion intervention | 3 months |