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

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.

Time to Treatment and In-Hospital Major Adverse Cardiac Events Among Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (PCI) According to the 24/7 Primary PCI Service Registry in Iran: Cross-Sectional Study.

BACKGROUND: Performing primary percutaneous coronary intervention (PCI) as a preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI) may be associated with major adverse cardiocerebrovascular events (MACCEs). Thus, timely primary PCI has been emphasized in order to improve outcomes. Despite guideline recommendations on trying to reduce the door-to-balloon time to <90 minutes in order to reduce mortality, less attention has been paid to other components of time to treatment, such as the symptom-to-balloon time, as an indicator of the total ischemic time, which includes the symptom-to-door time and door-to-balloon time, in terms of clinical outcomes of patients with STEMI undergoing primary PCI. OBJECTIVE: We aimed to determine the association between each component of time to treatment (ie, symptom-to-door time, door-to-balloon time, and symptom-to-balloon time) and in-hospital MACCEs among patients with STEMI who underwent primary PCI. METHODS: In this observational study, according to a prospective primary PCI 24/7 service registry, adult patients with STEMI who underwent primary PCI in one of six catheterization laboratories of Tehran Heart Center from November 2015 to August 2019, were studied. The primary outcome was in-hospital MACCEs, which was a composite index consisting of cardiac death, revascularization (ie, target vessel revascularization/target lesion revascularization), myocardial infarction, and stroke. It was compared at different levels of time to treatment (ie, symptom-to-door and door-to-balloon time <90 and ≥90 minutes, and symptom-to-balloon time <180 and ≥180 minutes). Data were analyzed using SPSS software version 24 (IBM Corp), with descriptive statistics, such as frequency, percentage, mean, and standard deviation, and statistical tests, such as chi-square test, t test, and univariate and multivariate logistic regression analyses, and with a significance level of <.05 and 95% CIs for odds ratios (ORs). RESULTS: Data from 2823 out of 3204 patients were analyzed (mean age of 59.6 years, SD 11.6 years; 79.5% male [n=2243]; completion rate: 88.1%). Low proportions of symptom-to-door time ≤90 minutes and symptom-to-balloon time ≤180 minutes were observed among the study patients (579/2823, 20.5% and 691/2823, 24.5%, respectively). Overall, 2.4% (69/2823) of the patients experienced in-hospital MACCEs, and cardiac death (45/2823, 1.6%) was the most common cardiac outcome. In the univariate analysis, the symptom-to-balloon time predicted in-hospital MACCEs (OR 2.2, 95% CI 1.1-4.4; P=.03), while the symptom-to-door time (OR 1.4, 95% CI 0.7-2.6; P=.34) and door-to-balloon time (OR 1.1, 95% CI 0.6-1.8, P=.77) were not associated with in-hospital MACCEs. In the multivariate analysis, only symptom-to-balloon time ≥180 minutes was associated with in-hospital MACCEs and was a predictor of in-hospital MACCEs (OR 2.3, 95% CI 1.1-5.2; P=.04). CONCLUSIONS: A longer symptom-to-balloon time was the only component associated with higher in-hospital MACCEs in the present study. Efforts should be made to shorten the symptom-to-balloon time in order to improve in-hospital MACCEs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13161.

Time to Treatment and In-Hospital Major Adverse Cardiac Events Among Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (PCI) According to the 24/7 Primary PCI Service Registry in Iran: Protocol for a Cross-Sectional Study.

BACKGROUND: Patients with ST-segment elevation myocardial infarction (STEMI) experience major adverse cardiac events (MACEs) following primary percutaneous coronary intervention (PCI). Although the relationship between time to treatment (eg, door-to-balloon time, symptom onset-to-balloon time, and symptom onset-to-door time) and 1-month all-cause mortality was assessed previously, its relationship with in-hospital MACEs and the effect of some clinical characteristics on this relationship were not considered. Furthermore, previous studies that were conducted in developed countries with a different quality of care cannot be applied in Iran, as Iran is a developing country and the studies were not performed according to the 24/7 primary PCI service registry. OBJECTIVE: The objective of this study protocol is to determine the relationship between time to treatment and in-hospital MACEs. METHODS: This cross-sectional study will take place at the Tehran Heart Center (THC), which is affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. Data related to patients with STEMI, who underwent primary PCI between March 2015 and March 2019, that have been prospectively recorded in the THC's 24/7 primary PCI service registry will be analyzed. The study outcome is the occurrence of in-hospital MACEs. Data analysis will be conducted using SPSS for Windows, version 16.0 (SPSS Inc). We will perform chi-square tests, independent-samples t tests, or the Mann-Whitney U test, as well as univariate and multivariate binary logistic regression with a significance level of less than .05 and 95% CI for odds ratios. RESULTS: From March 2015 to September 2017, 1586 patients were included in the THC service registry, consecutively. We will conduct a retrospective analysis of this registry on patient entries between March 2015 and March 2019 and data will be analyzed and published by the end of 2019. CONCLUSIONS: To our knowledge, this is the first observational study based on the 24/7 primary PCI service registry in Iran. The findings of this study may reveal current problems regarding time to treatment in STEMI management in the THC. Results from this study may help determine appropriate preventive strategies that need to be applied in order to reduce time-to-treatment delays and improve patients' outcomes following primary PCI in the setting of STEMI at the THC and similar clinical centers. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13161.

Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial.

BACKGROUND: Patients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies. OBJECTIVE: This study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives. METHODS: A single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys. RESULTS: This study is ongoing and is expected to be completed by the end of 2018. CONCLUSIONS: This is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/9209.