PAVS in Cardiology

NCT ID: NCT04656132

Last Updated: 2024-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-08-10

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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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:

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NYU Langone

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38207172 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20-00388

Identifier Type: -

Identifier Source: org_study_id

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