Phase 1
N=63
PAVS in Cardiology
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04656132 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Aug 2024
Primary outcome: Primary: Step Counts — 48770 steps
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Physical activity assessment, promotion and monitoring in a preventive cardiology clinic (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Step Counts |
48770 | — |
| PRIMARY BMI |
30 | — |
| PRIMARY Waist Circumference |
38.9 | — |
| PRIMARY Blood Pressure |
125; 76 | — |
| PRIMARY Blood Lipid Levels |
148; 43; 138 | — |
| PRIMARY Framingham Heart Study Risk Score |
8.6 | — |
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.
Eligibility Criteria
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:
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04656132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.