title: 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.
  
  
  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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00378950.
authors.affiliation: Division of General Internal Medicine, University of North Carolina School of Medicine, 5041 Old Clinic Bldg, CB#7110, Chapel Hill, NC 27599, USA. dewaltd@med.unc.edu
authors.forename: Darren A
authors.initials: DA
authors.lastname: DeWalt
authors.forename: Dean
authors.initials: D
authors.lastname: Schillinger
authors.forename: Bernice
authors.initials: B
authors.lastname: Ruo
authors.forename: Kirsten
authors.initials: K
authors.lastname: Bibbins-Domingo
authors.forename: David W
authors.initials: DW
authors.lastname: Baker
authors.forename: George M
authors.initials: GM
authors.lastname: Holmes
authors.forename: Morris
authors.initials: M
authors.lastname: Weinberger
authors.forename: Aurelia
authors.initials: A
authors.lastname: Macabasco-O'Connell
authors.forename: Kimberly
authors.initials: K
authors.lastname: Broucksou
authors.forename: Victoria
authors.initials: V
authors.lastname: Hawk
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Grady
authors.forename: Brian
authors.initials: B
authors.lastname: Erman
authors.forename: Carla A
authors.initials: CA
authors.lastname: Sueta
authors.forename: Patricia P
authors.initials: PP
authors.lastname: Chang
authors.forename: Crystal Wiley
authors.initials: CW
authors.lastname: Cene
authors.forename: Jia-Rong
authors.initials: JR
authors.lastname: Wu
authors.forename: Christine D
authors.initials: CD
authors.lastname: Jones
authors.forename: Michael
authors.initials: M
authors.lastname: Pignone
mesh_terms: D000368:Aged; D004522:Educational Status; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D005260:Female; D006333:Heart Failure / Q000401:mortality* / Q000523:psychology / Q000534:rehabilitation*; D017052:Hospital Mortality; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods* / Q000706:statistics & numerical data; D010359:Patient Readmission / Q000706:statistics & numerical data; D011788:Quality of Life; D012648:Self Care / Q000379:methods* / Q000706:statistics & numerical data