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Educational intervention to improve knowledge and clinical outcomes for low-literacy patients with congestive heart failure
ISRCTN ISRCTN11535170
DOI 10.1186/ISRCTN11535170
ClinicalTrials.gov identifier
EudraCT number
Public title Educational intervention to improve knowledge and clinical outcomes for low-literacy patients with congestive heart failure
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis A heart failure self-management program, designed for use by patients with a variety of literacy levels, would improve knowledge, heart failure-related quality of life, and reduce the combined endpoint of hospitalizations and death.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Heart failure
Participants - inclusion criteria Patients aged 30-80 years with heart failure who also took furosemide.
Participants - exclusion criteria 1. Moderate to severe dementia
2. Terminal illness with life expectancy less than 6 months
3. Severe hearing impairment
4. Blindness
5. Current substance abuse
6. A serum creatinine >4 mg/dl or on dialysis
7. A requirement of supplemental oxygen at home
8. Lacked a telephone
9. Patients who were scheduled to undergo cardiac surgery or awaiting heart transplant
Anticipated start date 15/11/2001
Anticipated end date 12/04/2003
Status of trial Completed
Patient information material
Target number of participants 150
Interventions The intervention group received the self-management training. The control group received usual care by their physician.
Primary outcome measure(s) Combined endpoint of hospitalization or death.
Secondary outcome measure(s) 1. Heart failure-related quality of life
2. Heart failure-related self-management behaviors
3. Heart failure-related knowledge
4. Heart failure-related self-efficacy
Sources of funding Pfizer Health Literacy Initiative (USA)
The Robert Wood Johnson Clinical Scholars Program (USA)
The University of North Carolina Program on Health Outcomes (USA)
Grant no. P30NR03962 from the National Institute of Nursing Research, NIH, to the Center for Research on Chronic Illness at the University of North Carolina (USA)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16533388
Contact name Dr  Michael  Pignone
  Address 5039 Old Clinic Building, CB#7110
  City/town Chapel Hill
  Zip/Postcode 27599
  Country United States of America
  Tel +1 919 966 2276
  Fax +1 919 966 2274
  Email pignone@med.unc.edu
Sponsor University of North Carolina (USA)
  Address 5039 Old Clinic Building, CB#7110
  City/town Chapel Hill
  Zip/Postcode 27599
  Country United States of America
  Sponsor website: www.med.unc.edu
Date applied 12/09/2005
Last edited 16/08/2011
Date ISRCTN assigned 27/09/2005
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