A Multisite Randomized Trial of a Single- versus Multi-Session Literacy Sensitive Self-Care Intervention for Patients with Heart Failure
Background—Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy.
Methods and Results—A 1-year, multisite, randomized controlled comparative effectiveness trial with 605 patients with HF. Those randomized to single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life (HFQOL) with pre-specified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio (IRR)=1.01 (95% Confidence Interval (CI): 0.83, 1.22). The effect of multisession training compared with single session training differed by literacy group: among low literacy, multisession yielded lower incidence of all-cause hospitalization and death: IRR=0.75 (0.45,1.25); and among higher literacy, multisession yielded higher incidence: IRR=1.22 (0.99,1.50) (interaction p=0.048). For HF-related hospitalization: among low literacy, multisession yielded lower incidence: IRR=0.53 (95% CI: 0.25,1.12); and among higher literacy, multisession yielded higher incidence: IRR=1.32 (95% CI: 0.92,1.88) (interaction p=0.005). HFQOL improved more for patients receiving multisession compared with single session at 1 and 6 months, but the difference at 12 months was smaller. Effects on HFQOL did not differ by literacy.
Conclusions—Overall, an intensive multisession intervention did not change clinical outcomes compared with a single session intervention. People with low literacy appear to benefit more from multisession than people with higher literacy.
Clinical Trial Registration Information—ClinicalTrials.gov; Identifier: NCT00378950.
- Received November 28, 2011.
- Accepted April 16, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited