PAVS in Cardiology

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04656132
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study
• Actual Study Start Date: Jul 14, 2021
• Actual Primary Completion Date: Aug 10, 2022
• Actual Study Completion Date: Aug 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Step-counts [3 months]

   Pedometer

2. BMI [3 months]

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

3. waist circumference [3 months]

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

4. blood pressure [3 months]

   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 [3 months]

   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 [3 months]

   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

Secondary Outcome Measures

1. Score on the The Practical, Robust Implementation and Sustainability Model (PRISM) [3 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Aug 29, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04656132
• Other Study ID Numbers: 20-00388
• First Posted: Dec 7, 2020
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Aug 22, 2022