Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Pignone, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00378950
First received: September 20, 2006
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

Heart failure (HF) affects 5 million people in the United States. Health literacy, which is the ability to read and comprehend important medical information, plays an important role in the health of individuals with HF. This study will evaluate the effectiveness of an educational program developed for various levels of health literacy at improving medical outcomes and quality of life in individuals with HF.


Condition Intervention Phase
Heart Failure, Congestive
Behavioral: Teach to Goal (TTG)
Behavioral: Brief Educational Intervention (BEI)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Health Literacy and Self-Management in Heart Failure

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • All cause hospitalization [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart failure quality-of-life [ Time Frame: Measured at 1, 6, 12 months ] [ Designated as safety issue: No ]
  • Heart failure-related hospitalizations [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Difference between groups for adoption of appropriate self-management knowledge and behaviors [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Enrollment: 605
Study Start Date: March 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups.
Behavioral: Brief Educational Intervention (BEI)
The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.
Other Name: BEI
Experimental: 2
Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups, as well as additional information on diuretic self adjustment. This group will then get several follow-up phone calls over the course of the year to reinforce these topics and help them master the knowledge and encourage behavior and lifestyle changes to align with these topics.
Behavioral: Teach to Goal (TTG)
The TTG program includes the Brief Educational Intervention (BEI) educational intervention, as well as education about diuretic self adjustment. In addition, follow-up phone calls are given to the TTG group to further reinforce the initial training and provide further training so participants will master the task.
Other Name: TTG

Detailed Description:

HF is a complicated disease that often requires individuals to carefully monitor their condition. Individuals with HF must follow strict medication regimens, adhere to diet and exercise recommendations, and closely monitor symptoms and changes in weight. Individuals with low health literacy skills may have a harder time comprehending medication dosing instructions, educational materials, and the overall complexity of managing HF than individuals with higher health literacy skills. Programs that focus on building self-care skills have been proven to reduce the rate of hospitalizations among individuals with HF; only one study, however, has specifically examined the importance of health literacy in the effectiveness of these programs. Teach to Goal (TTG), a program that focuses on developing self-care skills while incorporating medical information for various health literacy levels, may improve medical outcomes in individuals with HF. The purpose of this study is to evaluate the effectiveness of TTG at improving hospitalization and death rates, quality of life, and self-care behaviors among individuals with HF.

This 1-year study will enroll individuals with HF. Eligible participants will attend a baseline study visit and complete survey questionnaires. Participants will then be randomly assigned to either TTG or a control group. The TTG group will partake in a 30- to 60-minute educational session, which will focus on improving self-care skills. They will also receive literacy-sensitive printed materials about monitoring body weight and swelling in the legs, medication administration, and a sodium reduction and exercise plan. Control group participants will partake in a shorter educational session and will receive fewer printed materials. All participants will be provided with a digital scale to self-monitor their weight at home. The TTG group will receive follow-up phone calls on Days 3, 7, 14, 21, and 28, during which study staff will assess participants' progress and will provide additional support and training as necessary. Both groups will receive phone calls at Months 1, 6, and 12. During these calls, number of hospitalizations, quality of life, and changes in self-care behavior and knowledge will be evaluated, but participants will not receive any additional training.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of HF
  • Currently prescribed a Loop diuretic medication
  • At least one of the following findings:

    1. Chest x-ray consistent with HF (current or past x-ray with probable or definite pulmonary edema)
    2. Reduced ejection fraction on echocardiogram (ECHO), multiple gate acquisition scan (MUGA), or cardiac catheterization (less than 50%)
    3. Left ventricular hypertrophy (LVH) or diastolic filling pattern on ECHO
    4. Elevated B-type natriuretic peptide
  • Currently experiencing New York Heart Association Class II-IV symptoms or has experienced these symptoms in the 6 months prior to study entry
  • Has a working telephone
  • Speaks English or Spanish

Exclusion Criteria:

  • Patients will be ineligible if they meet ONE the following criteria:

    1. Sight - Inability to see printed educational material well enough to utilize it
    2. Cognition - Moderate to severe dementia (If medical notes state "Severe Dementia" or as determined by administering the study's cognitive screener)
    3. Surgery -Valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant)
    4. Terminal Illness - Possessing a terminal illness with prognosis of 1 year or less
    5. Dialysis - Currently on dialysis or anticipated to start dialysis within 1 year
    6. Oxygen Dependant - Using concentrate oxygen intermittent or continuously for COPD
    7. Management of Care - Not able to control medications
    8. Other Studies -Patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378950

Locations
United States, California
University of California - Los Angeles (UCLA)
Los Angeles, California, United States, 90024
University of California at San Francisco, San Francisco General Hospital
San Francisco, California, United States, 94143
United States, Illinois
Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago
Chicago, Illinois, United States, 60611
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Mike Pignone, MD, MPH University of North Carolina, Chapel Hill
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Pignone, MD, MPH, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00378950     History of Changes
Other Study ID Numbers: 439, R01HL081257-01A1, R01 HL081257-01A1
Study First Received: September 20, 2006
Last Updated: February 1, 2012
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014