Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure
|ClinicalTrials.gov Identifier: NCT00378950|
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Behavioral: Teach to Goal (TTG) Behavioral: Brief Educational Intervention (BEI)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||605 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Health Literacy and Self-Management in Heart Failure|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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
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
- All cause hospitalization [ Time Frame: Measured at 12 months ]
- All cause mortality [ Time Frame: Measured at 12 months ]
- Heart failure quality-of-life [ Time Frame: Measured at 1, 6, 12 months ]
- Heart failure-related hospitalizations [ Time Frame: Measured at 12 months ]
- Difference between groups for adoption of appropriate self-management knowledge and behaviors [ Time Frame: Measured at 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378950
|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|
|Principal Investigator:||Mike Pignone, MD, MPH||University of North Carolina, Chapel Hill|