Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-03-17 @ 10:32 PM
Study NCT ID:
NCT00577759
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2007-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community and Clinician Partnership for Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2007-12-13', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of referrals from the practices to the community resources', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Number of referrals received by each resource', 'timeFrame': '6 months'}, {'measure': 'The proportion of patients with unhealthy behaviors who were referred from the practices to community resources', 'timeFrame': '6 months'}, {'measure': 'Practice attitudes and practice regarding referral to community resources', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quality assurance, health care', 'primary health care', 'community health services', 'referral and consultation', 'exercise', 'diet', 'tobacco'], 'conditions': ['Physical Activity', 'Dietary Habits', 'Tobacco Use Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).', 'detailedDescription': 'Tobacco use, poor diet, and lack of physical activity are associated with the leading causes of significant morbidity and mortality, including coronary heart disease, hypertension, cancer, stroke, diabetes, and respiratory dysfunction. One solution to decreasing unhealthy behaviors would be to better integrate primary care providers with community resources, including community and public health organizations that already have the capacity and expertise to deliver effective interventions. This project is a randomized trial to evaluate different practice-level interventions to link practices to community resources to decrease unhealthy behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internal medicine and family practices in Durham and Orange counties, North Carolina\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00577759', 'acronym': 'C2P2', 'briefTitle': 'Community and Clinician Partnership for Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Community and Clinician Partnership for Prevention', 'orgStudyIdInfo': {'id': 'Pro00004061'}, 'secondaryIdInfos': [{'id': 'HHSA290200710014'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Intervention', 'description': 'Direct referral to community organizations, with support for practices to do so. These include the North Carolina Tobacco Quitline, public health department dietitians, and the YMCA.', 'interventionNames': ['Other: Active Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Passive Intervention', 'description': 'Provision of information about community organizations to patients as above.', 'interventionNames': ['Other: Passive Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': 'Usual care', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Active Intervention', 'type': 'OTHER', 'description': 'Quality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources', 'armGroupLabels': ['Active Intervention']}, {'name': 'Passive Intervention', 'type': 'OTHER', 'description': 'Provision of tools to help with referrals to community resources', 'armGroupLabels': ['Passive Intervention']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27715', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical Research Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Alex R Kemper, MD, MPH, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}