Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-01 @ 6:27 AM
Study NCT ID:
NCT00018005
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2001-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Self-Management Intervention for Mild to Moderate Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 902}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-19', 'studyFirstSubmitDate': '2001-06-26', 'studyFirstSubmitQcDate': '2001-06-25', 'lastUpdatePostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time until all-cause death or heart-failure hospitalization', 'timeFrame': 'Measured over the two years of study follow-up.', 'description': 'This is a composite outcome, measuring time from randomization to occurrence of death due to any cause or a hospitalization that is adjudicated to be due to heart-failure, among participants who experience either (or both) of these events. Only the first occurrence of either of these events is considered.'}], 'secondaryOutcomes': [{'measure': 'Progression of heart failure', 'timeFrame': 'Measured over the two years of study follow-up', 'description': 'Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.'}, {'measure': 'Quality of life', 'timeFrame': 'Measured over the two years of study follow-up', 'description': 'Measured using self-report heart-failure-specific quality of life scales.'}, {'measure': 'Health care costs', 'timeFrame': 'Measured over the two years of study follow-up'}, {'measure': 'Time until all-cause death or all-cause hospitalization', 'timeFrame': 'Measured over the two years of study follow-up', 'description': 'This is a composite outcome, measuring time from randomization to occurrence of death due to any cause or hospitalization for any reason, among participants who experience either (or both) of these events. Only the first occurrence of either of these events is considered.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Self-Management', 'Behavioral Clinical Trial'], 'conditions': ['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '26853954', 'type': 'DERIVED', 'citation': 'Doukky R, Mangla A, Ibrahim Z, Poulin MF, Avery E, Collado FM, Kaplan J, Richardson D, Powell LH. Impact of Physical Inactivity on Mortality in Patients With Heart Failure. Am J Cardiol. 2016 Apr 1;117(7):1135-43. doi: 10.1016/j.amjcard.2015.12.060. Epub 2016 Jan 18.'}, {'pmid': '26738949', 'type': 'DERIVED', 'citation': 'Doukky R, Avery E, Mangla A, Collado FM, Ibrahim Z, Poulin MF, Richardson D, Powell LH. Impact of Dietary Sodium Restriction on Heart Failure Outcomes. JACC Heart Fail. 2016 Jan;4(1):24-35. doi: 10.1016/j.jchf.2015.08.007.'}, {'pmid': '20858878', 'type': 'DERIVED', 'citation': 'Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.'}, {'pmid': '18760125', 'type': 'DERIVED', 'citation': 'Powell LH, Calvin JE Jr, Mendes de Leon CF, Richardson D, Grady KL, Flynn KJ, Rucker-Whitaker CS, Janssen I, Kravitz G, Eaton C; Heart Failure Adherence and Retention Trial Investigators. The Heart Failure Adherence and Retention Trial (HART): design and rationale. Am Heart J. 2008 Sep;156(3):452-60. doi: 10.1016/j.ahj.2008.05.011.'}]}, 'descriptionModule': {'briefSummary': 'This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.', 'detailedDescription': 'BACKGROUND:\n\nHeart failure is a major disabling disease for American adults, affecting an estimated 4.9 million individuals. Heart failure is associated with enormous health care expenditures. This is because it is a progressive chronic condition that is characterized by disabling symptoms that limit independence and result in multiple hospitalizations and referrals to long-term care. The emergence of heart failure as a major public health problem is related to the unintended result of both an aging population and the success in reducing mortality from cardiovascular disease. Non-adherence to medications is a key problem in the treatment of heart failure, with adherence rates ranging from 20% to 90%. There is a clear need, therefore, to develop interventions that improve adherence in patients with heart failure.\n\nDESIGN NARRATIVE:\n\nThis is a single-site, partially blinded, randomized clinical trial of 900 patients with systolic or diastolic dysfunction, and New York Heart Association (NYHA) functional class II or III. Patients will be recruited over a period of 2 years from seven hospitals. Patients will be randomly assigned to either a SM intervention or attention control. The SM group will meet 18 times for 2 hours over 1 year. These group sessions will teach patients how to use five basic self-management skills (self-monitoring, environmental restructuring, social support, cognitive restructuring, and the relaxation response) to help build self-efficacy and maintain it after the treatment has been discontinued. The attention control arm will consist of an educational intervention which includes 18 mailings of the American Heart Association Tip Sheets over the course of the first year, plus a telephone follow-up with the patient after each mailing to check receipt and comprehension of the Tip Sheet, and to address any questions about the Tip Sheet. Treatment effects will be evaluated using the primary outcome of hospitalization for heart failure or death, and the secondary outcomes of progression of heart failure, quality of life, and health care costs. Potential mediators of effectiveness will include improved adherence and improved psychosocial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NYHA classification of II or III\n* LVEF of 40% or less\n\nExclusion Criteria:\n\n* Uncertain 12-month prognosis\n* Potential cardiac transplant within 1 year of study entry\n* Severe aortic stenosis\n* Uncontrolled ventricular tachycardia\n* Non-cardiac causes of heart failure symptoms (i.e., peripheral vascular disease, chronic obstructive pulmonary disease, and arthritis)\n* Major psychiatric co-morbidity\n* Unstable angina, myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 1 month prior to study entry'}, 'identificationModule': {'nctId': 'NCT00018005', 'acronym': 'HART', 'briefTitle': 'A Self-Management Intervention for Mild to Moderate Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Heart Failure Adherence and Retention Trial (HART)', 'orgStudyIdInfo': {'id': '137'}, 'secondaryIdInfos': [{'id': 'R01HL065547', 'link': 'https://reporter.nih.gov/quickSearch/R01HL065547', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Self-Management', 'type': 'BEHAVIORAL', 'description': '18 in-person group sessions providing self-management training.'}, {'name': 'attention control', 'type': 'OTHER', 'description': '18 educational mailings follow by a a telephone call.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush-Presbyterian-St. Lukes Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Lynda H. Powell', 'role': 'STUDY_CHAIR', 'affiliation': 'Rush-Presbyterian-St. Lukes Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lynda Powell, PhD, MEd', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair, Department Preventive Medicine', 'investigatorFullName': 'Lynda Powell, PhD, MEd', 'investigatorAffiliation': 'Rush University Medical Center'}}}}