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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lynda Powell, PhD, MEd, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00018005
First received: June 26, 2001
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Behavioral: Self-Management
Other: attention control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Heart Failure Adherence and Retention Trial (HART)

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Time until all-cause death or heart-failure hospitalization [ Time Frame: Measured over the two years of study follow-up. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression of heart failure [ Time Frame: Measured over the two years of study follow-up ] [ Designated as safety issue: No ]
    Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.

  • Quality of life [ Time Frame: Measured over the two years of study follow-up ] [ Designated as safety issue: No ]
    Measured using self-report heart-failure-specific quality of life scales.

  • Health care costs [ Time Frame: Measured over the two years of study follow-up ] [ Designated as safety issue: No ]
  • Time until all-cause death or all-cause hospitalization [ Time Frame: Measured over the two years of study follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 902
Study Start Date: June 2001
Study Completion Date: June 2007
Intervention Details:
    Behavioral: Self-Management
    18 in-person group sessions providing self-management training.
    Other: attention control
    18 educational mailings follow by a a telephone call.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018005

Locations
United States, Illinois
Rush-Presbyterian-St. Lukes Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Lynda Powell, PhD, MEd
Investigators
Study Chair: Lynda H. Powell Rush-Presbyterian-St. Lukes Medical Center
  More Information

No publications provided by Rush University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynda Powell, PhD, MEd, Chair, Department Preventive Medicine, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00018005     History of Changes
Other Study ID Numbers: 137, R01HL065547, R01 HL65547
Study First Received: June 26, 2001
Last Updated: October 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Rush University Medical Center:
Heart Failure
Self-Management
Behavioral Clinical Trial

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 18, 2014