Condition category
Circulatory System
Date applied
12/09/2005
Date assigned
27/09/2005
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Pignone

ORCID ID

Contact details

5039 Old Clinic Building
CB#7110
Chapel Hill
27599
United States of America
+1 919 966 2276
pignone@med.unc.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Heart failure

Intervention

The intervention group received the self-management training. The control group received usual care by their physician.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/11/2001

Overall trial end date

12/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 30-80 years with heart failure who also took furosemide.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

15/11/2001

Recruitment end date

12/04/2003

Locations

Countries of recruitment

United States of America

Trial participating centre

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

Sponsor information

Organisation

University of North Carolina (USA)

Sponsor details

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

Sponsor type

University/education

Website

www.med.unc.edu

Funders

Funder type

Other

Funder name

Pfizer Health Literacy Initiative (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Robert Wood Johnson Clinical Scholars Program (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The University of North Carolina Program on Health Outcomes (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16533388

Publication citations

  1. Results

    DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, Sueta CA, Pignone MP, A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170]., BMC Health Serv Res, 2006, 6, 30, doi: 10.1186/1472-6963-6-30.

Additional files

Editorial Notes