A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170].

BACKGROUND: Self-management programs for patients with heart failure can reduce hospitalizations and mortality. However, no programs have analyzed their usefulness for patients with low literacy. We compared the efficacy of a heart failure self-management program designed for patients with low literacy versus usual care. METHODS: We performed a 12-month randomized controlled trial. From November 2001 to April 2003, we enrolled participants aged 30-80, who had heart failure and took furosemide. Intervention patients received education on self-care emphasizing daily weight measurement, diuretic dose self-adjustment, and symptom recognition and response. Picture-based educational materials, a digital scale, and scheduled telephone follow-up were provided to reinforce adherence. Control patients received a generic heart failure brochure and usual care. Primary outcomes were combined hospitalization or death, and heart failure-related quality of life. RESULTS: 123 patients (64 control, 59 intervention) participated; 41% had inadequate literacy. Patients in the intervention group had a lower rate of hospitalization or death (crude incidence rate ratio (IRR) = 0.69; CI 0.4, 1.2; adjusted IRR = 0.53; CI 0.32, 0.89). This difference was larger for patients with low literacy (IRR = 0.39; CI 0.16, 0.91) than for higher literacy (IRR = 0.56; CI 0.3, 1.04), but the interaction was not statistically significant. At 12 months, more patients in the intervention group reported monitoring weights daily (79% vs. 29%, p < 0.0001). After adjusting for baseline demographic and treatment differences, we found no difference in heart failure-related quality of life at 12 months (difference = -2; CI -5, +9). CONCLUSION: A primary care-based heart failure self-management program designed for patients with low literacy reduces the risk of hospitalizations or death.

Development and pilot testing of a disease management program for low literacy patients with heart failure.

UNLABELLED: Development and pilot testing of a disease management program for low literacy patients with heart failure. BACKGROUND: Randomized trials have shown that disease management programs can reduce hospitalizations and improve symptoms for patients with congestive heart failure. We sought to create and pilot test such a program for patients with low literacy skills. METHODS: We used focus groups and individual cognitive response interviews (CRIs) to develop an educational booklet for low literacy patients with heart failure. We incorporated the booklet into a disease management intervention that also included an initial individualized 1-h educational session and scheduled supportive phone calls that were tapered over 6 weeks. We then conducted a 3-month before-after study on patients with low literacy skills (<9th grade literacy level) in a university internal medicine clinic to test the acceptability and efficacy of our program. Outcomes of interest included heart failure-related knowledge, self-care behavior and heart failure-related symptoms measured on the Minnesota Living with Heart Failure (MLwHF) scale. RESULTS: Twenty-five patients were enrolled and 23 (92%) completed 3-month follow-up. Mean age was 60 years (range 35-74), 60% were men, 60% were African-American, and 74% had household income under $15,000 per year. The median reading level was fifth grade with 32% reading at or below the third grade level. Mean knowledge score at baseline was 67% and did not improve after the intervention. The proportion of patients reporting weighing themselves daily increased from 32% at baseline to 100% at 12 weeks. Mean improvement on the MLwHF scale was 9.9 points over the 3-month trial (95% CI: 0.5, 19.2), which corresponds to an improvement in one class on the New York Heart Association heart failure scale. CONCLUSION: A heart failure disease management program designed specifically for patients with low literacy skills is acceptable and is associated with improvement in self-care behavior and heart failure related symptoms.