Efficacy of a self-monitoring traffic light diary on outcomes of patients with heart failure: A randomized controlled trial.

ABSTRACT

BACKGROUND AND OBJECTIVE: Patients with heart failure experience high hospitalization. However, patients cannot recognize symptoms according to current approaches, which needs to be improved by new self-monitoring instruments and strategies. Thus, we aimed to assess a self-monitoring traffic light diary on outcomes of patients with heart failure. METHODS: This was a single-blind, two-arm parallel group randomized controlled trial at the heart failure clinic of Tehran Heart Center (Tehran, Iran). Adult patients with a definitive diagnosis of heart failure with reduced ejection fraction (i.e., ejection fraction of less than 40 %), and New York Heart Association functional classes II-IV were included. A block-balanced randomization method was used to assign eligible subjects to the intervention or control group. Baseline data were collected before random allocation. Participants in the intervention group received a comprehensive intervention consisting of (1) self-care education by an Australian Heart Foundation booklet on heart failure, (2) regular self-monitoring of weight and shortness of breath at home, and (3) scheduled call follow-ups for three months. Patients in the control group received usual care. The primary outcome was heart failure self-care; the secondary outcomes were heart failure quality of life, knowledge, and all-cause hospitalization. RESULTS: From June to August 2017, 68 patients were included in the study. The overall age of participants was 55 (13.6) years old, and 71 % of patients were male. A significant association between the intervention and self-care maintenance (ß 5.1; 95 % CI 2.50 to 7.70, P < 0.001), self-care management (ß 10.6; 95 % CI 6.50 to 14.8, P < 0.001), self-care confidence (ß 8.0; 95 % CI 5.0 to 11.0, P < 0.001) and heart failure knowledge (ß 1.7; 95 % CI 1.30, 2.04; P < 0.001) was found. However, there was no association between the intervention and quality of life (ß 2.5; 95 % CI -0.79, 5.88, P 0.135) and hospitalization-free survival of the two groups (Log-Rank P 0.540). CONCLUSION: A self-monitoring traffic light diary can improve self-care behaviors and heart failure knowledge in patients with heart failure with reduced ejection fraction. RCT APPROVAL ID Iranian Registry of Clinical Trials IRCT2017021032476N1. STUDY PROTOCOL PMCID PMC6262204.