A Self-Management Intervention for Mild to Moderate Heart Failure (HART)

October 19, 2012 updated by: Lynda Powell, PhD, MEd

Heart Failure Adherence and Retention Trial (HART)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

902

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Lukes Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time until all-cause death or heart-failure hospitalization
Time Frame: Measured over the two years of study follow-up.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of heart failure
Time Frame: Measured over the two years of study follow-up
Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.
Measured over the two years of study follow-up
Quality of life
Time Frame: Measured over the two years of study follow-up
Measured using self-report heart-failure-specific quality of life scales.
Measured over the two years of study follow-up
Health care costs
Time Frame: Measured over the two years of study follow-up
Measured over the two years of study follow-up
Time until all-cause death or all-cause hospitalization
Time Frame: Measured over the two years of study follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lynda Powell, PhD, MEd

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Chair: Lynda H. Powell, Rush-Presbyterian-St. Lukes Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 26, 2001

First Submitted That Met QC Criteria

June 25, 2001

First Posted (Estimate)

June 26, 2001

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 19, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137
  • R01HL065547 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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