Cardiovascular DiseasesPhase 1NCT04656132
PAVS in Cardiology
A Phase 1 study testing Physical activity assessment, promotion and monitoring in a preventive cardiology clinic in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Physical activity assessment, promotion and monitoring in a preventive cardiology clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 10 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study
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
- Being tested
- Physical activity assessment, promotion and monitoring in a preventive cardiology clinic
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity assessment, promotion and monitoring in a preventive cardiology clinicBehavioural
physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Counts
Pedometer
Measured: Month 3
BMI
BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.
Measured: Month 3
Waist Circumference
Waist Circumference will be measured to the nearest inch using standard technique
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start14 Jul 2021
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656132
- Sponsor's protocol ID
- 20-00388
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2020
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to:mmm529@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
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.
PubMed 38207172
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study
- ClinicalTrials.gov ID
- NCT04656132
- Acronym / sponsor ID
- 20-00388
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with cardiovascular disease or cardiovascular disease risk factors | Experimental | Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinicPopulation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity assessment, promotion and monitoring in a preventive cardiology clinicphysical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center | Behavioural | Participants with cardiovascular disease or cardiovascular disease risk factors |
Primary outcome
Step Counts
Time frame: Month 3
Pedometer
BMI
Time frame: 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
Time frame: Month 3
Waist Circumference will be measured to the nearest inch using standard technique
Blood Pressure
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38207172McCarthy 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.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to:mmm529@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical activity assessment, promotion and monitoring in a preventive cardiology clinic in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Counts (time frame: Month 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.