PAVS in Cardiology

NCT04656132 | Completed Phase 1 Results DMC

• 1 other identifier: 20-00388
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Participants with cardiovascular disease or cardiovascular disease risk factors

EXPERIMENTAL

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

Interventions

Physical activity assessment, promotion and monitoring in a preventive cardiology clinic BEHAVIORAL

physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center

Participants with cardiovascular disease or cardiovascular disease risk factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

Related Publications (1)

• McCarthy MM, Szerencsy A, Taza-Rocano L, Hopkins S, Mann D, D'Eramo Melkus G, Vorderstrasse A, Katz SD. Implementing a Clinical Decision Support Tool to Improve Physical Activity. Nurs Res. 2024 May-Jun 01;73(3):216-223. doi: 10.1097/NNR.0000000000000714. Epub 2024 Jan 11.

  PMID: 38207172 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Margaret M. McCarthy, PhD, RN, FNP-BC
• Organization: NYU Rory Meyers College of Nursing

mmm529@nyu.edu

212-992-5796

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: July 14, 2021
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication
• Access Criteria: Requests should be directed to mmm529@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)