Multisite randomized trial of a single-session versus multisession literacy-sensitive self-care intervention for patients with heart failure

Abstract

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 was conducted. Those randomized to a 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, with prespecified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio, 1.01; 95% confidence interval, 0.83-1.22). The effect of multisession training compared with single-session training differed by literacy group: Among those with low literacy, the multisession training yielded a lower incidence of all-cause hospitalization and death (incidence rate ratio, 0.75; 95% confidence interval, 0.45-1.25), and among those with higher literacy, the multisession intervention yielded a higher incidence (incidence rate ratio, 1.22; 95% confidence interval, 0.99-1.50; interaction P=0.048). For HF-related hospitalization, among those with low literacy, multisession training yielded a lower incidence (incidence rate ratio, 0.53; 95% confidence interval, 0.25-1.12), and among those with higher literacy, it yielded a higher incidence (incidence rate ratio, 1.32; 95% confidence interval, 0.92-1.88; interaction P=0.005). HF-related quality of life improved more for patients receiving multisession than for those receiving single-session interventions at 1 and 6 months, but the difference at 12 months was smaller. Effects on HF-related quality of life 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 interventions than people with higher literacy.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00378950.

Figure 1

Flow diagram of progress through the study. Footnote at bottom of Figure 1: *Response rates for the 6 and 12 month interviews differed by literacy group with lower literacy participants more likely to miss the interview (for example, at 12 months, response rate for low literacy was 80% and for higher literacy 90%). However, the difference in response rates by literacy was not different between the study groups.

Figure 2

Change in HFQOL from baseline at 1, 6, and 12 months. (a) all study patients, (b) only those with adequate literacy, and (c) only those with lower (inadequte) literacy.

Figure 2

Change in HFQOL from baseline at 1, 6, and 12 months. (a) all study patients, (b) only those with adequate literacy, and (c) only those with lower (inadequte) literacy.

Figure 2

Change in HFQOL from baseline at 1, 6, and 12 months. (a) all study patients, (b) only those with adequate literacy, and (c) only those with lower (inadequte) literacy.

Figure 3

Subgroup analysis for differences in heart failure related hospitalization for the multisession group compared to the single session group. (Adjusted for site, HFQOL, ACE/ARB use, and subjective SES.)