A Self-Management Intervention for Mild to Moderate Heart Failure (HART)
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Self-Management
attention control
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Heart Failure, Self-Management, Behavioral Clinical Trial
Eligibility 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
Sites / Locations
- Rush-Presbyterian-St. Lukes Medical Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression of heart failure
Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.
Quality of life
Measured using self-report heart-failure-specific quality of life scales.
Health care costs
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.
Full Information
NCT ID
NCT00018005
First Posted
June 26, 2001
Last Updated
October 19, 2012
Sponsor
Lynda Powell, PhD, MEd
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00018005
Brief Title
A Self-Management Intervention for Mild to Moderate Heart Failure
Acronym
HART
Official Title
Heart Failure Adherence and Retention Trial (HART)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lynda Powell, PhD, MEd
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
Keywords
Heart Failure, Self-Management, Behavioral Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
902 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Self-Management
Intervention Description
18 in-person group sessions providing self-management training.
Intervention Type
Other
Intervention Name(s)
attention control
Intervention Description
18 educational mailings follow by a a telephone call.
Primary Outcome Measure Information:
Title
Time until all-cause death or heart-failure hospitalization
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.
Time Frame
Measured over the two years of study follow-up.
Secondary Outcome Measure Information:
Title
Progression of heart failure
Description
Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.
Time Frame
Measured over the two years of study follow-up
Title
Quality of life
Description
Measured using self-report heart-failure-specific quality of life scales.
Time Frame
Measured over the two years of study follow-up
Title
Health care costs
Time Frame
Measured over the two years of study follow-up
Title
Time until all-cause death or all-cause hospitalization
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.
Time Frame
Measured over the two years of study follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda H. Powell
Organizational Affiliation
Rush-Presbyterian-St. Lukes Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Rush-Presbyterian-St. Lukes Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26853954
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.
Results Reference
derived
PubMed Identifier
26738949
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.
Results Reference
derived
PubMed Identifier
20858878
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.
Results Reference
derived
PubMed Identifier
18760125
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.
Results Reference
derived
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A Self-Management Intervention for Mild to Moderate Heart Failure
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