PAVS in Cardiology

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with cardiovascular disease or cardiovascular disease risk factors; 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; physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Counts	Pedometer	Month 3
BMI	BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.	Month 3
Waist Circumference	Waist Circumference will be measured to the nearest inch using standard technique	Month 3
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.	Month 3
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.	Month 3
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. 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.	Month 3

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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 20-00388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to:mmm529@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Requests should be directed to mmm529@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No