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ISRCTN
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ISRCTN11535170
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ClinicalTrials.gov identifier
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Public title
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Educational intervention to improve knowledge and clinical outcomes for low-literacy patients with congestive heart failure
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Heart failure
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Participants - inclusion criteria
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Patients aged 30-80 years with heart failure who also took furosemide.
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Participants - exclusion criteria
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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
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Anticipated start date
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15/11/2001
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Anticipated end date
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12/04/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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The intervention group received the self-management training. The control group received usual care by their physician.
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Primary outcome measure(s)
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Combined endpoint of hospitalization or death.
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Secondary outcome measure(s)
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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
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Sources of funding
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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)
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16533388
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Contact name
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Dr
Michael
Pignone
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Address
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5039 Old Clinic Building, CB#7110
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City/town
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Chapel Hill
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Zip/Postcode
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27599
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Country
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United States of America
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Tel
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+1 919 966 2276
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Fax
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+1 919 966 2274
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Email
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pignone@med.unc.edu
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Sponsor
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University of North Carolina (USA)
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Address
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5039 Old Clinic Building, CB#7110
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City/town
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Chapel Hill
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Zip/Postcode
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27599
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Country
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United States of America
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Sponsor website:
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www.med.unc.edu
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Date applied
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12/09/2005
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Last edited
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16/08/2011
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Date ISRCTN assigned
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27/09/2005
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