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Clinical Trials/KCT0009112
KCT0009112
Completed
未知

ong term effects of smart care program based on clinical prognosis map for the prevention of heart failure in myocardial infarction patients with left ventricular dysfunction

Hanyang University Seoul Hospital0 sites68 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the circulatory system
Sponsor
Hanyang University Seoul Hospital
Enrollment
68
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Background: To prevent progression to heart failure, which is expected to occur due to aging and an increase in myocardial infarction, self-management of lifestyle habits and risk factors is necessary in middle-aged men after myocardial infarction who are at risk. Objectives: This study aimed to develop a smartphone app that self-monitors lifestyle habits and risk factors weekly and provides individualized algorithm-based feedback, and to verify its effectiveness for 12 months. This study developed a smartphone app that included a checklist for weekly self-monitoring of lifestyle habits and risk factors and individualized algorithm-based feedback, and provided assistant consultation from a nurse regarding the application and application results of the app. An attempt was made to verify the effect over the years. Design: This study applied a prospective, single-blinded, two-arm, randomized controlled trial with a repeated measure design. Participants and Setting: We recruited middle-aged male post myocardial infarction patients with a moderately reduced left ventricular ejection fraction = 50% from the cardiology outpatient or ward of two university hospitals in Seoul, Korea from August 2021 to July 2023. Methods: The smartphone app included a weekly lifestyle habits self-monitoring checklist, providing algorithm-based feedback messages by an animated nurse, and learning information. Additionally, the app generated visualized data from the accumulated checklist results, and a nurse provided face-to-face feedback during patients’ regular outpatient visits. Data were collected using a structured self-report questionnaire, and repeated measures ANOVA was applied using the SPSS/WIN 240.0 program to test hypotheses about the effectiveness of the intervention after three, six, and 12 months. Results: Health behaviors increased in the intervention group (n = 35) compared to the control group (n = 33) at three, six, and 12 months, and the main effect, time, and interaction effects between groups were significant (F = 10.24, p < .001). Depression (F = 3.55, p = .020) and negative illness perception (F = 6.23, p < .001) decreased significantly over time in both groups, but there was no difference between the groups. There was a significant time and group interaction effect on illness perception (F = 3.15, p = .026). In resilience, there was a significant main effect of the difference between groups (F = 5.54, p = .022), but the interaction effect with time was not significant. Conclusions: Weekly self-monitoring of lifestyle habits using a smartphone app had a positive effect on improving health behavior over 12 month period in middle-aged male post-myocardial infarction patients at risk for heart failure. Follow-up studies are needed to determine whether the use of this smartphone app maintains longer-term behavioral changes and improves heart failure-related physiological indicators.

Registry
who.int
Start Date
TBD
End Date
August 14, 2023
Last Updated
2 years ago
Study Type
Interventional Study
Sex
Male

Investigators

Sponsor
Hanyang University Seoul Hospital

Eligibility Criteria

Inclusion Criteria

  • 1\) those with a moderate decrease in left ventricular systolic function \= 50% on echocardiography within the last three months, corresponding to heart failure Stage B, 2\) those classified by a physician as being in the early or risk group for heart failure diagnosed and classified outpatients or patients about to be discharged, 3\) those not using ventricular assist devices, 4\) those with stable physical condition and ability to communicate without cognitive dysfunction, and 5\) those who understand the purpose of the study and can use a smartphone and agree to participate

Exclusion Criteria

  • The exclusion criteria include those participating in other exercise intervention programs such as cardiac rehabilitation.

Outcomes

Primary Outcomes

Not specified

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