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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00378950 |
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 |
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Heart Failure, Congestive |
Behavioral: Teach to Goal (TTG) Behavioral: Brief Educational Intervention (BEI) |
Phase 0 |
Study Type: | Interventional |
Study Design: | Double Blind (Investigator, Outcomes Assessor), Efficacy Study, Parallel Assignment, Randomized |
Official Title: | Health Literacy and Self-Management in Heart Failure |
Estimated Enrollment: | 660 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups.
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Behavioral: Brief Educational Intervention (BEI)
The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.
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2: Experimental
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.
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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.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following findings:
Exclusion Criteria:
Patients will be ineligible if they meet ONE the following criteria:
Contact: Kimberly A. Broucksou, MSW, MPA | 919-966-0047 | kbroucksou@schsr.unc.edu |
Contact: Mike Pignone, MD, MPH | 919-966-2276 ext 234 | Michael_Pignone@med.unc.edu |
United States, California | |
University of California at San Francisco, San Francisco General Hospital | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Dean Schillinger, MD 415-206-8940 dschillinger@medsfgh.ucsf.edu | |
Contact: Kirsten Bibbins-Domingo, MD, PhD 415-206-4464 kdomingo@medsfgh.ucsf.edu | |
Principal Investigator: Dean Schillinger, MD | |
United States, Illinois | |
Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: David W. Baker, MD 312-695-8630 dbaker1@nmff.org | |
Contact: Joe Feinglass, PhD 312-695-4962 j-feinglass@northwestern.edu | |
Principal Investigator: David W. Baker, MD | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Kimberly A. Broucksou, MSW, MPA 919-966-0047 kbroucksou@schsr.unc.edu | |
Contact: Darren DeWalt, MD, MPA 919-966-2276 darren_dewalt@med.unc.edu | |
Principal Investigator: Mike Pignone, MD, MPH |
Principal Investigator: | Mike Pignone, MD, MPH | The University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina ( Michael Pignone, MD, MPH ) |
Study ID Numbers: | 439, R01 HL081257-01A1 |
Study First Received: | September 20, 2006 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00378950 History of Changes |
Health Authority: | United States: Federal Government |
Congestive Heart Failure |
Heart Failure Heart Diseases Diuretics |
Heart Failure Heart Diseases Cardiovascular Diseases |