How effective is an in-hospital heart failure self-care program in a Japanese setting? Lessons from a randomized controlled pilot study

Naoko P Kato,1–3 Koichiro Kinugawa,1 Miho Sano,4 Asuka Kogure,4 Fumika Sakuragi,5 Kihoko Kobukata,4 Hiroshi Ohtsu,6 Sanae Wakita,4 Tiny Jaarsma,2 Keiko Kazuma7 1Department of Therapeutic Strategy for Heart Failure, The University of Tokyo Graduate School of Medicine, Tokyo, Japan; 2Department of Social and Welfare Studies, Faculty of Health Sciences, Linköping University, Linköping, Sweden; 3JSPS Postdoctoral Fellow for Research Abroad, Tokyo, 4Department of Nursing, 5Department of Pharmacy, The University of Tokyo Hospital, 6Department of Clinical Data Management, 7Department of Adult Nursing, The University of Tokyo Graduate School of Medicine, Tokyo, Japan Background: Although the effectiveness of heart failure (HF) disease management programs has been established in Western countries, to date there have been no such programs in Japan. These programs may have different effectiveness due to differences in health care organization and possible cultural differences with regard to self-care. Therefore, the purpose of this study was to evaluate the effectiveness of a pilot HF program in a Japanese setting.Methods: We developed an HF program focused on enhancing patient self-care before hospital discharge. Patients were randomized 1:1 to receive the new HF program or usual care. The primary outcome was self-care behavior as assessed by the European Heart Failure Self-Care Behavior Scale (EHFScBS). Secondary outcomes included HF knowledge and the 2-year rate of HF hospitalization and/or cardiac death.Results: A total of 32 patients were enrolled (mean age, 63 years; 31% female). There was no difference in the total score of the EHFScBS between the two groups. One specific behavior score regarding a low-salt diet significantly improved compared with baseline in the intervention group. HF knowledge in the intervention group tended to improve more over 6 months than in the control group (a group-by-time effect, F=2.47, P=0.098). During a 2-year follow-up, the HF program was related to better outcomes regarding HF hospitalization and/or cardiac death (14% vs 48%, log-rank test P=0.04). In Cox regression analysis after adjustment for age, sex, and logarithmic of B-type natriuretic peptide, the program was associated with a reduction in HF hospitalization and/or cardiac death (hazard ratio, 0.17; 95% confidence interval, 0.03–0.90; P=0.04).Conclusion: The HF program was likely to increase patients’ HF knowledge, change their behavior regarding a low-salt diet, and reduce HF hospitalization and/or cardiac events. Further improvement focused on the transition of knowledge to self-care behavior is necessary. Keywords: discharge education, disease management, hospitalization, knowledge, nursing, patient educatio