A Randomized Controlled Trial to Improve Heart Failure Disparities: The Mālama Pu‘uwai (Caring for Heart) Study
Marjorie K. Leimomi Mala Mau, Eunjung Lim, Joseph Keawe‘aimoku Kaholokula, Taylor M.U. Loui, Yongjun Cheng, and Todd B. Seto
Open Access Journal of Clinical Trials
Objective/Background: To conduct a randomized controlled trial to test the efficacy of a culturally tailored heart failure (HF) education program, to reduce HF hospital readmissions and/or cardiovascular disease death (HF outcomes) among Native Hawaiian and Other Pacific Islander (NHOPI) patients with HF.
Methods: One hundred fifty HF patients aged ≥21 years, NHOPI race, and discharged to home were enrolled and randomized to the Mālama Puʻuwai Program (MPP) or the usual care (UC). The MPP group received a culturally tailored HF program, and the UC received similar standard
HF education materials. Clinical and health behavior data were measured at baseline and 12 months. HF outcomes were monitored throughout the entire study period. Two-sample t-test, chi-square, and Cox proportional hazard modeling assessed the efficacy of intervention (MPP or UC) on HF outcomes using an intention-to-treat approach. A sensitivity post hoc analysis was performed on patients who completed the full intervention (n=127).
Results: Overall, 69% were men, mean age 54.4±13.4 years, 62% were Native Hawaiian, and 24% reported methamphetamine use. More UC participants reported methamphetamine use (32% vs. 16%), hypertension (81% vs. 63%), but less myocardial infarction (27% vs. 48%). HF outcomes were higher in UC (31%) compared with MPP (19%) with higher risk for HF outcomes (hazard ratio [HR] 1.74; 95% CI: 0.89–3.40). Sensitivity post hoc analysis of intervention compliance revealed that UC was at significantly higher risk for HF outcomes than MPP (HR 2.83; 95% CI: 1.19–6.72).
Conclusions: Culturally tailored HF programs have the potential to reduce HF outcomes among compliant minority patients with HF such as NHOPI.Download PDF