Status:
COMPLETED
Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Heart failure (HF) affects 5 million people in the United States. Health literacy, which is the ability to read and comprehend important medical information, plays an important role in the health of i...
Detailed Description
HF is a complicated disease that often requires individuals to carefully monitor their condition. Individuals with HF must follow strict medication regimens, adhere to diet and exercise recommendation...
Eligibility Criteria
Inclusion
- Clinical diagnosis of HF
- Currently prescribed a Loop diuretic medication
- At least one of the following findings:
- Chest x-ray consistent with HF (current or past x-ray with probable or definite pulmonary edema)
- Reduced ejection fraction on echocardiogram (ECHO), multiple gate acquisition scan (MUGA), or cardiac catheterization (less than 50%)
- Left ventricular hypertrophy (LVH) or diastolic filling pattern on ECHO
- Elevated B-type natriuretic peptide
- Currently experiencing New York Heart Association Class II-IV symptoms or has experienced these symptoms in the 6 months prior to study entry
- Has a working telephone
- Speaks English or Spanish
Exclusion
- Patients will be ineligible if they meet ONE the following criteria:
- Sight - Inability to see printed educational material well enough to utilize it
- Cognition - Moderate to severe dementia (If medical notes state "Severe Dementia" or as determined by administering the study's cognitive screener)
- Surgery -Valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant)
- Terminal Illness - Possessing a terminal illness with prognosis of 1 year or less
- Dialysis - Currently on dialysis or anticipated to start dialysis within 1 year
- Oxygen Dependant - Using concentrate oxygen intermittent or continuously for COPD
- Management of Care - Not able to control medications
- Other Studies -Patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT00378950
Start Date
March 1 2007
End Date
February 1 2011
Last Update
May 4 2017
Active Locations (4)
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1
University of California - Los Angeles (UCLA)
Los Angeles, California, United States, 90024
2
University of California at San Francisco, San Francisco General Hospital
San Francisco, California, United States, 94143
3
Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago
Chicago, Illinois, United States, 60611
4
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599