A Self-Management Intervention for Mild to Moderate Heart Failure

Cardiovascular Diseases Clinical Trial

— HART  

Official title:

Heart Failure Adherence and Retention Trial (HART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018005
• Other study ID #: 137
• Secondary ID: R01HL065547
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2001
• Last updated: October 19, 2012
• Start date: June 2001
• Est. completion date: June 2007

Study information

• Verified date: October 2012
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

BACKGROUND:

Heart 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.

DESIGN NARRATIVE:

This 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 902
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• NYHA classification of II or III

• LVEF of 40% or less

Exclusion Criteria:

• Uncertain 12-month prognosis

• Potential cardiac transplant within 1 year of study entry

• Severe aortic stenosis

• Uncontrolled ventricular tachycardia

• Non-cardiac causes of heart failure symptoms (i.e., peripheral vascular disease, chronic obstructive pulmonary disease, and arthritis)

• Major psychiatric co-morbidity

• Unstable angina, myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 1 month prior to study entry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Heart Failure, Congestive

Intervention

Behavioral:
• Self-Management
18 in-person group sessions providing self-management training.

Other:
• attention control
18 educational mailings follow by a a telephone call.

Locations

Country	Name	City	State
United States	Rush-Presbyterian-St. Lukes Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Lynda Powell, PhD, MEd	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until all-cause death or heart-failure hospitalization	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.	Measured over the two years of study follow-up.	No
Secondary	Progression of heart failure	Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.	Measured over the two years of study follow-up	No
Secondary	Quality of life	Measured using self-report heart-failure-specific quality of life scales.	Measured over the two years of study follow-up	No
Secondary	Health care costs		Measured over the two years of study follow-up	No
Secondary	Time until all-cause death or all-cause hospitalization	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.	Measured over the two years of study follow-up	No