Trial Outcomes & Findings for PAVS in Cardiology (NCT NCT04656132)
NCT ID: NCT04656132
Last Updated: 2024-08-07
Results Overview
Pedometer
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Month 3
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
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.
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
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|---|---|
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Overall Study
STARTED
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63
|
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Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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.
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
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|---|---|
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Overall Study
Lost to Follow-up
|
4
|
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Overall Study
Lost to Follow-Up Prior to Baseline Data Collection
|
4
|
Baseline Characteristics
PAVS in Cardiology
Baseline characteristics by cohort
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=59 Participants
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.
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
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|---|---|
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Age, Continuous
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61.13 years
STANDARD_DEVIATION 11.6 • n=5 Participants
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Sex: Female, Male
Female
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30 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Pedometer
Outcome measures
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=55 Participants
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.
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
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|---|---|
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Step Counts
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48770 steps
Standard Deviation 27362
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PRIMARY outcome
Timeframe: Month 3BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.
Outcome measures
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=55 Participants
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.
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
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|---|---|
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BMI
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30 kg/m^2
Standard Deviation 7
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PRIMARY outcome
Timeframe: Month 3Waist Circumference will be measured to the nearest inch using standard technique
Outcome measures
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=55 Participants
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.
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
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|---|---|
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Waist Circumference
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38.9 inches
Standard Deviation 6
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PRIMARY outcome
Timeframe: Month 3Blood 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.
Outcome measures
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=55 Participants
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.
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
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|---|---|
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Blood Pressure
Systolic
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125 mmHg
Standard Deviation 16
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Blood Pressure
Diastolic
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76 mmHg
Standard Deviation 14
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PRIMARY outcome
Timeframe: Month 3Total 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.
Outcome measures
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=55 Participants
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.
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
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|---|---|
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Blood Lipid Levels
Cholesterol
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148 mg/dl
Standard Deviation 45
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Blood Lipid Levels
HDL
|
43 mg/dl
Standard Deviation 18
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Blood Lipid Levels
Triglycerides
|
138 mg/dl
Standard Deviation 76
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PRIMARY outcome
Timeframe: Month 3The 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.
Outcome measures
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=55 Participants
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.
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
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|---|---|
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Framingham Heart Study Risk Score
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8.6 Percentage risk
Standard Deviation 9.7
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Adverse Events
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=63 participants at risk
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.
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
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Hospitalization for an Asthma Exacerbation
|
1.6%
1/63 • 3 months
PI monitored for adverse events systematically at the followup visit, and informally during the study period with self-reporting by the subjects.
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Other adverse events
| Measure |
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors
n=63 participants at risk
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.
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
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|---|---|
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General disorders
Hip Fracture
|
1.6%
1/63 • 3 months
PI monitored for adverse events systematically at the followup visit, and informally during the study period with self-reporting by the subjects.
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Additional Information
Margaret M. McCarthy, PhD, RN, FNP-BC
NYU Rory Meyers College of Nursing
Phone: 212-992-5796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place