PAVS in Cardiology

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656132
• Other study ID #: 20-00388
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2021
• Est. completion date: August 10, 2022

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step-counts	Pedometer	3 months
Primary	BMI	BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.	3 months
Primary	waist circumference	Waist Circumference will be measured to the nearest inch using standard technique	3 months
Primary	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
Primary	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
Primary	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	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