Educational intervention to improve knowledge and clinical outcomes for low-literacy patients with congestive heart failure

ISRCTN	ISRCTN11535170
DOI	https://doi.org/10.1186/ISRCTN11535170
Protocol serial number	N/A
Sponsor	University of North Carolina (USA)
Funders	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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael Pignone
Scientific

5039 Old Clinic Building, CB#7110
Chapel Hill
27599
United States of America

Phone	+1 919 966 2276
Email	pignone@med.unc.edu

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Heart failure
Intervention	The intervention group received the self-management training. The control group received usual care by their physician.
Intervention type	Other
Primary outcome measure(s)	Combined endpoint of hospitalization or death.
Key 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
Completion date	12/04/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key inclusion criteria	Patients aged 30-80 years with heart failure who also took furosemide.
Key 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
Date of first enrolment	15/11/2001
Date of final enrolment	12/04/2003

5039 Old Clinic Building, CB#7110

Chapel Hill
27599
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	13/03/2006		Yes	No