NCT00378950

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

Health Literacy and Self-Management in Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
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.
BEHAVIORAL	Brief Educational Intervention (BEI)	The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2006-09-21
• Last updated: 2017-05-04

Locations

4 sites across 1 country: United States