Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 1:23 AM
Study NCT ID:
NCT00778804
Status:
COMPLETED
Last Update Posted:
2008-10-23
First Post:
2008-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Heart Disease in Underserved Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-22', 'studyFirstSubmitDate': '2008-10-22', 'studyFirstSubmitQcDate': '2008-10-22', 'lastUpdatePostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Framingham 10-year risk index', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CVD risk', 'self monitoring', 'Internet', 'telemedicine'], 'conditions': ['Hypertension', 'Diabetes Mellitus', 'Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '22512287', 'type': 'DERIVED', 'citation': 'Homko CJ, Deeb LC, Rohrbacher K, Mulla W, Mastrogiannis D, Gaughan J, Santamore WP, Bove AA. Impact of a telemedicine system with automated reminders on outcomes in women with gestational diabetes mellitus. Diabetes Technol Ther. 2012 Jul;14(7):624-9. doi: 10.1089/dia.2012.0010. Epub 2012 Apr 18.'}, {'pmid': '21315219', 'type': 'DERIVED', 'citation': 'Bove AA, Santamore WP, Homko C, Kashem A, Cross R, McConnell TR, Shirk G, Menapace F. Reducing cardiovascular disease risk in medically underserved urban and rural communities. Am Heart J. 2011 Feb;161(2):351-9. doi: 10.1016/j.ahj.2010.11.008.'}, {'pmid': '20436354', 'type': 'DERIVED', 'citation': 'McConnell TR, Santamore WP, Larson SL, Homko CJ, Kashem M, Cross RC, Bove AA. Rural and urban characteristics impact cardiovascular risk reduction. J Cardiopulm Rehabil Prev. 2010 Sep-Oct;30(5):299-308. doi: 10.1097/HCR.0b013e3181d6fb82.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).', 'detailedDescription': 'The Insight Telehealth system (ITSMyHealthfile) is a disease-managment interactive health care delivery system. Patients access the system through a special Web site using a password. The system prompts the patient to enter their weight, blood pressure and heart rate and there is a text box available for unstructed comments.\n\nPatients will be randomized to either the telemedicine group or usual care group (controls). Individuals in the telemedicine group will be asked to transmit their health status weekly. Both groups will be followed for one year with quarterly visits.\n\nPatients of either sex, of any ethnic background or race, between 22 and 85years of age, who have a 10% or greater 10-year risk of CVD based on the Framingham risk score, and risk factors that if properly treated would reduced the risk by 5% or greater will be eligible for the study.\n\nAdditional criteria\n\n* literate\n* telephone access\n* ablility to utilize the Internet and telemedicine system (after training) Primary Outcome Reduction in Framingham risk index'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Framingham risk score equal to or greater than 10%\n* literacy\n* 22 -85 years of age\n* access to phone\n\n * ability to use Internet and system following training\n\nExclusion Criteria:\n\n* Class 3 and 4 heart failure\n* ESRD\n* stroke with residual disability or dementia\n* unable to read or write'}, 'identificationModule': {'nctId': 'NCT00778804', 'briefTitle': 'Preventing Heart Disease in Underserved Patients', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Preventing Heart Disease in Underserved Patients', 'orgStudyIdInfo': {'id': '4159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'telemedicine', 'description': 'Web-based monitoring in addition to usual clincial care with quarterly visits', 'interventionNames': ['Behavioral: telemedicine']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Ususal care with quarterly visits'}], 'interventions': [{'name': 'telemedicine', 'type': 'BEHAVIORAL', 'description': 'Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement', 'armGroupLabels': ['telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hosptial', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alfred A Bove, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Geisinger Clinic', 'class': 'OTHER'}, {'name': 'Insight Telehealth Systems', 'class': 'INDUSTRY'}, {'name': 'Pennsylvania Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Catherine Becker', 'oldOrganization': 'Pennsylvania Department of Health'}}}}