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

May 1, 2017 updated by: University of North Carolina, Chapel Hill

Health Literacy and Self-Management in Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

605

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California - Los Angeles (UCLA)
      • San Francisco, California, United States, 94143
        • University of California at San Francisco, San Francisco General Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • TTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause hospitalization
Time Frame: Measured at 12 months
Measured at 12 months
All cause mortality
Time Frame: Measured at 12 months
Measured at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart failure quality-of-life
Time Frame: Measured at 1, 6, 12 months
Measured at 1, 6, 12 months
Heart failure-related hospitalizations
Time Frame: Measured at 12 months
Measured at 12 months
Difference between groups for adoption of appropriate self-management knowledge and behaviors
Time Frame: Measured at 12 months
Measured at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mike Pignone, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 439
  • R01HL081257-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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