Cardiovascular Diseases
Conditions
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.
Interventions
BEHAVIORALPhysical 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
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step Counts | Month 3 | Pedometer |
| BMI | Month 3 | BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale. |
| Waist Circumference | Month 3 | Waist Circumference will be measured to the nearest inch using standard technique |
| Blood Pressure | Month 3 | 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. |
| Blood Lipid Levels | Month 3 | 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. |
| Framingham Heart Study Risk Score | Month 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Lost to Follow-Up Prior to Baseline Data Collection | 4 |
Baseline characteristics
| Characteristic | Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors |
|---|---|
| Age, Continuous | 61.13 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 1 / 63 |
| serious Total, serious adverse events | 1 / 63 |
Outcome results
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.
Time frame: Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Blood Lipid Levels | HDL | 43 mg/dl | Standard Deviation 18 |
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Blood Lipid Levels | Triglycerides | 138 mg/dl | Standard Deviation 76 |
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Blood Lipid Levels | Cholesterol | 148 mg/dl | Standard Deviation 45 |
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.
Time frame: Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Blood Pressure | Systolic | 125 mmHg | Standard Deviation 16 |
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Blood Pressure | Diastolic | 76 mmHg | Standard Deviation 14 |
Primary
BMI
BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | BMI | 30 kg/m^2 | Standard Deviation 7 |
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. 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.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Framingham Heart Study Risk Score | 8.6 Percentage risk | Standard Deviation 9.7 |
Primary
Step Counts
Pedometer
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Step Counts | 48770 steps | Standard Deviation 27362 |
Primary
Waist Circumference
Waist Circumference will be measured to the nearest inch using standard technique
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors | Waist Circumference | 38.9 inches | Standard Deviation 6 |