Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01071967
Status:
UNKNOWN
Last Update Posted:
2013-09-10
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular 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': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019468', 'term': 'Disease Management'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2010-02-18', 'lastUpdatePostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'within 5 years of enrollment'}], 'secondaryOutcomes': [{'measure': 'Blood pressure control', 'timeFrame': 'within 5 years of enrollment'}, {'measure': 'Total cholesterol control', 'timeFrame': 'within 5 years of enrollment'}, {'measure': 'Low density cholesterol control', 'timeFrame': 'within 5 years of enrollment'}, {'measure': 'Triglycerides control', 'timeFrame': 'within 5 years of enrollment'}, {'measure': 'Weight control', 'timeFrame': 'within 5 years of enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Community Health Nursing', 'Nursing Care Management', 'Aged', 'Aged, 80 and over', 'Health Services for the Aged', 'Geriatric Nursing', 'Geriatric Assessment', 'Longevity', 'Mortality'], 'conditions': ['Heart Failure', 'Coronary Disease', 'Diabetes Mellitus', 'Asthma', 'Hypertension', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '19211468', 'type': 'BACKGROUND', 'citation': 'Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.'}, {'pmid': '19040171', 'type': 'BACKGROUND', 'citation': 'Brown R, Peikes D, Chen A, Schore J. 15-site randomized trial of coordinated care in Medicare FFS. Health Care Financ Rev. 2008 Fall;30(1):5-25.'}, {'pmid': '19124858', 'type': 'BACKGROUND', 'citation': 'Bott DM, Kapp MC, Johnson LB, Magno LM. Disease management for chronically ill beneficiaries in traditional Medicare. Health Aff (Millwood). 2009 Jan-Feb;28(1):86-98. doi: 10.1377/hlthaff.28.1.86.'}, {'pmid': '22815653', 'type': 'DERIVED', 'citation': 'Coburn KD, Marcantonio S, Lazansky R, Keller M, Davis N. Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial. PLoS Med. 2012;9(7):e1001265. doi: 10.1371/journal.pmed.1001265. Epub 2012 Jul 17.'}], 'seeAlsoLinks': [{'url': 'http://www.hqp.org', 'label': 'Health Quality Partners'}, {'url': 'http://www.clinicaltrials.gov/ct2/show/NCT00627029?term=Medicare+Coordinated+Care+Demonstration&rank=1', 'label': 'Related ClinicalTrials.gov study'}]}, 'descriptionModule': {'briefSummary': 'Care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. This study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population. The results reflect the impact of one of the study sites (Health Quality Partners) selected by the Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated Care Demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults. The study began in April 2002.', 'detailedDescription': 'The community-based nursing care management model developed by Health Quality Partners represents a comprehensive set of integrated preventive and monitoring services designed for older adults living with chronic diseases. The individual programs and services integrated within the model were selected on the basis of previously demonstrated evidence of effectiveness. The model is delivered in the communities in which participants reside. Care is delivered through in person contacts, (1 to 1 and group) as well as by telephone. In person contacts occur in the home, in readily accessible community and faith-based organizations, health facilities, or the offices of Health Quality Partners. Efforts are made to contact participants in the intervention group at least monthly with care continued until death, voluntary disenrollment, mandatory disenrollment due to changes in insurance coverage, relocation out of the service area, or change in long term level of care (e.g., nursing home placement, hospice).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 65 years and older\n* Medicare Part A and B traditional, fee for service insurance coverage\n* One or more of the following chronic conditions:\n* Heart failure\n* Coronary Disease\n* Diabetes mellitus\n* Asthma\n* Hypertension\n* Hypercholesterolemia\n* A Geriatric Risk Stratification Level of 2 or more based on a pre-enrollment screening tool\n* Geriatric Risk Stratification Level changed in Sep 2006 to a Level of 3 or more\n* Willingness of the participant's primary care provider to collaborate\n\nExclusion Criteria:\n\n* Amyotrophic lateral sclerosis\n* Alzheimer's disease\n* Dementia\n* Diagnosis or history of cancer (other than skin) in the past 5 years\n* End-stage renal disease\n* Life expectancy on enrollment less than 6 months\n* HIV or AIDS\n* Huntington's disease\n* Organ transplant candidate\n* Psychosis or schizophrenia\n* Resident of or imminent plan for long-term nursing home placement\n* Seasonal relocation outside of the area for more than 4 weeks per year\n* Anyone receiving service from Health Quality Partners in the past"}, 'identificationModule': {'nctId': 'NCT01071967', 'briefTitle': 'Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Health Quality Partners'}, 'officialTitle': 'Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults', 'orgStudyIdInfo': {'id': '95-C-91360/3-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community-based nurse care management', 'description': 'Participants randomized to receive the intervention worked with a nurse care manager who provided them with a comprehensive set of geriatric and chronic disease preventive services.', 'interventionNames': ['Other: Community-based nurse care management']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants randomized to the control group received usual care without the involvement of a nurse care manager.'}], 'interventions': [{'name': 'Community-based nurse care management', 'type': 'OTHER', 'otherNames': ['Health Quality Partners', 'Medicare Coordinated Care Demonstration', 'Care Coordination', 'Disease Management'], 'description': 'The community-based nurse care management program developed by Health Quality Partners uses nurses working in the community to provide the following integrated set of services to older adults with chronic illness over the long term in order to prevent avoidable complications of their diseases and aging; geriatric assessment, care coordination, health education, self-management coaching, weight management, physical activity, gait and balance training, medication adherence, care transition support, ongoing monitoring and symptom detection, collaborative problem solving with patients, families and health care providers.', 'armGroupLabels': ['Community-based nurse care management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18902', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Health Quality Partners', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}], 'overallOfficials': [{'name': 'Kenneth D Coburn, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Quality Partners'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Health Quality Partners', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Medicare and Medicaid Services', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}