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Randomized Controlled Trial
. 2024 Apr 29:26:e52075.
doi: 10.2196/52075.

Effectiveness of a Smartphone App-Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial

Minjae Yoon  1 , Seonhwa Lee  2 , Jah Yeon Choi  3 , Mi-Hyang Jung  4 , Jong-Chan Youn  4 , Chi Young Shim  5 , Jin-Oh Choi  6 , Eung Ju Kim  3 , Hyungseop Kim  2 , Byung-Su Yoo  7 , Yeon Joo Son  8 , Dong-Ju Choi  1
Affiliations
Randomized Controlled Trial

Effectiveness of a Smartphone App-Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial

Minjae Yoon et al. J Med Internet Res. .

Abstract

Background: Current heart failure (HF) guidelines recommend a multidisciplinary approach, discharge education, and self-management for HF. However, the recommendations are challenging to implement in real-world clinical settings.

Objective: We developed a mobile health (mHealth) platform for HF self-care to evaluate whether a smartphone app-based intervention with Bluetooth-connected monitoring devices and a feedback system can help improve HF symptoms.

Methods: In this prospective, randomized, multicenter study, we enrolled patients 20 years of age and older, hospitalized for acute HF, and who could use a smartphone from 7 tertiary hospitals in South Korea. In the intervention group (n=39), the apps were automatically paired with Bluetooth-connected monitoring devices. The patients could enter information on vital signs, HF symptoms, diet, medications, and exercise regimen into the app daily and receive feedback or alerts on their input. In the control group (n=38), patients could only enter their blood pressure, heart rate, and weight using conventional, non-Bluetooth devices and could not receive any feedback or alerts from the app. The primary end point was the change in dyspnea symptom scores from baseline to 4 weeks, assessed using a questionnaire.

Results: At 4 weeks, the change in dyspnea symptom score from baseline was significantly greater in the intervention group than in the control group (mean -1.3, SD 2.1 vs mean -0.3, SD 2.3; P=.048). A significant reduction was found in body water composition from baseline to the final measurement in the intervention group (baseline level mean 7.4, SD 2.5 vs final level mean 6.6, SD 2.5; P=.003). App adherence, which was assessed based on log-in or the percentage of days when symptoms were first observed, was higher in the intervention group than in the control group. Composite end points, including death, rehospitalization, and urgent HF visits, were not significantly different between the 2 groups.

Conclusions: The mobile-based health platform with Bluetooth-connected monitoring devices and a feedback system demonstrated improvement in dyspnea symptoms in patients with HF. This study provides evidence and rationale for implementing mobile app-based self-care strategies and feedback for patients with HF.

Trial registration: ClinicalTrials.gov NCT05668000; https://clinicaltrials.gov/study/NCT05668000.

Keywords: heart failure; mobile applications; mobile health; mobile phone; self-care; vital sign monitoring.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Study design of the (A) SMART-HF trial and (B) system of app and platform. (A) Patients with acute HF were randomized into the intervention (app with monitoring devices and feedback) or control (app only) groups. (B) The app and platform are comprised of three parts (1) a smartphone app for patients, (2) a dashboard system for physicians, and (3) a clinical decision support system on the platform. PC: personal computer; SMART-HF: self-monitoring using a mobile app to improve symptoms and reduce rehospitalization and mortality in heart failure.
Figure 2
Figure 2
Application menu screens and functions. (A) Menu screens and (B) application functions. BP: blood pressure; DBP: diastolic blood pressure; HR: heart rate; SBP: systolic blood pressure.
Figure 3
Figure 3
CONSORT flow diagram. CONSORT: Consolidated Standards of Reporting Trials; ICU: intensive care unit.
Figure 4
Figure 4
Change in dyspnea symptom score in the intervention and control groups. (A) Dyspnea score during the trial follow-up. (B) Change in dyspnea score from baseline to 4 weeks. The error bars represent the 95% CI.
Figure 5
Figure 5
Change in body water composition level from baseline to last measurement in the intervention group.
Figure 6
Figure 6
Distribution of app adherence according to the treatment groups. App adherence was assessed based on log in in (A) the intervention and (B) control groups. App adherence evaluated based on the percentage of days when symptoms were entered into the app in (C) the intervention and (D) control groups. IQR, interquartile range.
See this image and copyright information in PMC

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