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 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2005
- Registration date
- 27/09/2005
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Pignone
Scientific
Scientific
5039 Old Clinic Building, CB#7110
Chapel Hill
27599
United States of America
| Phone | +1 919 966 2276 |
|---|---|
| pignone@med.unc.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | Combined endpoint of hospitalization or death. |
| Secondary outcome measures | 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 |
| Overall study start date | 15/11/2001 |
| Completion date | 12/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- United States of America
Study participating centre
5039 Old Clinic Building, CB#7110
Chapel Hill
27599
United States of America
27599
United States of America
Sponsor information
University of North Carolina (USA)
University/education
University/education
5039 Old Clinic Building, CB#7110
Chapel Hill
27599
United States of America
| Website | www.med.unc.edu |
|---|---|
"ROR" |
https://ror.org/0130frc33 |
Funders
Funder type
Other
Pfizer Health Literacy Initiative (USA)
No information available
The Robert Wood Johnson Clinical Scholars Program (USA)
No information available
The University of North Carolina Program on Health Outcomes (USA)
No information available
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 13/03/2006 | Yes | No |
