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Home > "H" Clinical Trials Conditions > Heart Failure Adherence and Retention Trial (HART)  Heart Failure Adherence and Retention Trial (HART)
Heart Failure Adherence and Retention Trial (HART)
For Condition: Heart Failure, Congestive,Cardiovascular Diseases,Heart Diseases,Heart Failure
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To 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.
Details: BACKGROUND: Heart failure is a major disabling disease for American adults, affecting an estimated 4.9 million individuals. Because heart failure is a progressive chronic condition, characterized by disabling symptoms which limit independence and result in multiple hospitalizations and referral to long-term care it is associated with enormous health care expenditures. The emergence of heart failure as a major public health problem appears related to the unintended result of both the aging of the population and 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 percent. There is a clear need, therefore, to develop interventions that improve adherence in patients with heart failure. DESIGN NARRATIVE: This is a single-site, partially blinded, randomized clinical trial of 900 patients with systolic or diastolic dysfunction and NYHA functional class II, or III. Patients will be recruited over a period of two years using seven hospitals. Patients will be randomized to self-management intervention or an attention control and will meet 18 times for 1.5 hours over one year. These 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 them build self-efficacy and maintain it after the treatment has been discontinued. The attention control intervention will consist of a didactic lecture series about medical topics and heart failure. 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 include improved adherence and improved psychosocial function.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LyndaPowell, , Rush-Presbyterian-St. Lukes Medical Center
Rush-Presbyterian-St. Lukes Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Dr. H. Powell 312-942-2013
Additional Information:
Study ID Numbers: 137;
Study Start Date: June 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018005
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5. Genomewide Search for Loci Underlying Metabolic Syndrome
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Heart Failure Adherence and Retention Trial (HART)
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