Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 3:44 PM
Study NCT ID:
NCT01894750
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2013-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Building Skill in Heart Failure Self-care: A Community Based Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in baseline Health related quality of life at 1 month', 'timeFrame': 'Changes in baseline health related quality of life at 1 month', 'description': 'Health related quality of life will be measured using valid and reliable Kansas City Cardiomyopathy Questionnaire. Changes in scores will be assessed from baseline to 3 months'}, {'measure': 'Changes in baseline Health related quality of life at 3 month', 'timeFrame': 'Changes in baseline health related quality of life at 3 month', 'description': 'Health related quality of life will be measured using valid and reliable Kansas City Cardiomyopathy Questionnaire. Changes in scores will be assessed from baseline to 3 months'}], 'primaryOutcomes': [{'measure': 'Change in baseline heart failure self-care score at one month', 'timeFrame': 'Change from baseline heart failure self-care at 1 month', 'description': 'Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline at one month will be assessed.'}, {'measure': 'Change in baseline heart failure self-care score at 3 months', 'timeFrame': 'Change from baseline heart failure self-care at 3 months', 'description': 'Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline to 3 months will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Change in baseline Heart failure knowledge score at 1 month', 'timeFrame': 'Change in baseline Heart failure knowledge score at 1 month', 'description': 'Heart failure knowledge will be measured using the valid and reliable Dutch Heart Failure Knowledge survey. Changes in total score from baseline at 1 month will be assessed.'}, {'measure': 'Change in baseline Heart failure knowledge score at 3 month', 'timeFrame': 'Change in baseline Heart failure knowledge score at 3 month', 'description': 'Heart failure knowledge will be measured using the valid and reliable Dutch Heart Failure Knowledge survey. Changes in total heart failure knowledge score from baseline to 3 months will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Self-Care'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We will test three hypotheses comparing 60 older adults with heart failure randomly assigned to either the intervention or a control group:\n\nHypothesis 1. Participants in the intervention group will have significantly improved heart failure self-care than control participants.\n\nHypothesis 2. Participants in the intervention group will have significantly improved knowledge about heart failure and heart failure self-care than control participants.\n\nHypothesis 3. Participants in the intervention group will have significantly better Health Related Quality of Life than control participants.\n\nA secondary exploratory aim is to assess and describe implementation feasibility of providing a heart failure self-care intervention in a community group setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of chronic HF\n* able to read and speak English or Spanish\n* over age 50\n\nExclusion Criteria:\n\n* history of prior neurological event (e.g., stroke, head injury, encephalopathy) that could cause dementia\n* unable to perform tests or participate in the intervention session (e.g., inability to communicate verbally, major visual impairment, or severe and uncorrected hearing loss).\n* living in a nursing home or other long term care facility'}, 'identificationModule': {'nctId': 'NCT01894750', 'briefTitle': 'Building Skill in Heart Failure Self-care: A Community Based Intervention', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Building Skill in Heart Failure Self-Care: A Community Based Intervention', 'orgStudyIdInfo': {'id': 'R10-02126'}, 'secondaryIdInfos': [{'id': '10CRP4140049', 'type': 'OTHER', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'skill bulding Intevention', 'description': 'group-based skill building self-care program', 'interventionNames': ['Behavioral: group-based skill building self-care program']}, {'type': 'NO_INTERVENTION', 'label': 'usual care'}], 'interventions': [{'name': 'group-based skill building self-care program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['skill bulding Intevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Victoria Vaughan Dickson, PhD, RN, FAHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU College of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}