Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 11:23 AM
Study NCT ID:
NCT04656132
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PAVS in Cardiology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmm529@nyu.edu', 'phone': '212-992-5796', 'title': 'Margaret M. McCarthy, PhD, RN, FNP-BC', 'organization': 'NYU Rory Meyers College of Nursing'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'PI monitored for adverse events systematically at the followup visit, and informally during the study period with self-reporting by the subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 1, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization for an Asthma Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Step Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'classes': [{'categories': [{'measurements': [{'value': '48770', 'spread': '27362', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Pedometer', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Waist Circumference will be measured to the nearest inch using standard technique', 'unitOfMeasure': 'inches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'classes': [{'title': 'Systolic', 'categories': [{'measurements': [{'value': '125', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic', 'categories': [{'measurements': [{'value': '76', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Lipid Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'classes': [{'title': 'Cholesterol', 'categories': [{'measurements': [{'value': '148', 'spread': '45', 'groupId': 'OG000'}]}]}, {'title': 'HDL', 'categories': [{'measurements': [{'value': '43', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '138', 'spread': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': "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.", 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Framingham Heart Study Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': "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.", 'unitOfMeasure': 'Percentage risk', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-Up Prior to Baseline Data Collection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors', 'description': '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.\n\nPhysical 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'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.13', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-25', 'size': 745522, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-06T07:55', 'hasProtocol': True}, {'date': '2021-02-23', 'size': 306175, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-04T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2020-11-30', 'resultsFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-04', 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step Counts', 'timeFrame': 'Month 3', 'description': 'Pedometer'}, {'measure': 'BMI', 'timeFrame': 'Month 3', 'description': 'BMI will be calculated by height and weight measured at the time of the Center visit on a balance beam scale.'}, {'measure': 'Waist Circumference', 'timeFrame': 'Month 3', 'description': 'Waist Circumference will be measured to the nearest inch using standard technique'}, {'measure': 'Blood Pressure', 'timeFrame': 'Month 3', 'description': '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.'}, {'measure': 'Blood Lipid Levels', 'timeFrame': 'Month 3', 'description': "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."}, {'measure': 'Framingham Heart Study Risk Score', 'timeFrame': 'Month 3', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '38207172', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult 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:\n\n1. Patients must achieve \\< 50% of PA recommendations according to PAVS screening questions\n2. Have a cellular phone with data plan or a computer to sync Fitbit data\n3. Speak English or Spanish\n4. Be willing to wear a Fitbit Zip for 3 months\n\nExclusion Criteria:\n\n1. Adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. wheelchair bound, aortic stenosis, unstable angina)\n2. Planned surgery within three months\n3. Those with decisional incapacity therefore unable to comply with study requirements (i.e. related to cognitive deficits or psychiatric diagnosis)\n4. Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT04656132', 'briefTitle': 'PAVS in Cardiology', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study', 'orgStudyIdInfo': {'id': '20-00388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with cardiovascular disease or cardiovascular disease risk factors', 'description': '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.', 'interventionNames': ['Behavioral: Physical activity assessment, promotion and monitoring in a preventive cardiology clinic']}], 'interventions': [{'name': 'Physical activity assessment, promotion and monitoring in a preventive cardiology clinic', 'type': 'BEHAVIORAL', 'description': 'physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center', 'armGroupLabels': ['Participants with cardiovascular disease or cardiovascular disease risk factors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'beginning 9 months and ending 36 months following article publication', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Requests should be directed to mmm529@nyu.edu. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}