A Smartphone-Based Model of Care to Support Patients With Cardiac Disease Transitioning From Hospital to the Community (TeleClinical Care): Pilot Randomized Controlled Trial

Abstract

Background: Patients hospitalized with acute coronary syndrome (ACS) or heart failure (HF) are frequently readmitted. This is the first randomized controlled trial of a mobile health intervention that combines telemonitoring and education for inpatients with ACS or HF to prevent readmission.

Objective: This study aims to investigate the feasibility, efficacy, and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care [TCC]) in patients discharged after ACS or HF admission.

Methods: In this pilot, 2-center randomized controlled trial, TCC was applied at discharge along with usual care to intervention arm participants. Control arm participants received usual care alone. Inclusion criteria were current admission with ACS or HF, ownership of a compatible smartphone, age ≥18 years, and provision of informed consent. The primary end point was the incidence of unplanned 30-day readmissions. Secondary end points included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness, and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure, and physical activity daily plus usual care. The devices automatically transmitted recordings to the patients' smartphones and a central server. Thresholds for blood pressure, heart rate, and weight were determined by the treating cardiologists. Readings outside these thresholds were flagged to a monitoring team, who discussed salient abnormalities with the patients' usual care providers (cardiologists, general practitioners, or HF outreach nurses), who were responsible for further management. The app also provided educational push notifications. Participants were followed up after 6 months.

Results: Overall, 164 inpatients were randomized (TCC: 81/164, 49.4%; control: 83/164, 50.6%; mean age 61.5, SD 12.3 years; 130/164, 79.3% men; 128/164, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P=.97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002). The average usability rating for the app was 4.5/5. The intervention cost Aus $6028 (US $4342.26) per cardiac readmission saved. When modeled in a mainstream clinical setting, enrollment of 237 patients was projected to have the same expenditure compared with usual care, and enrollment of 500 patients was projected to save approximately Aus $100,000 (approximately US $70,000) annually.

Conclusions: TCC was feasible and safe for inpatients with either ACS or HF. The incidence of 30-day readmissions was similar; however, long-term benefits were demonstrated, including fewer readmissions over 6 months, improved medication adherence, and improved cardiac rehabilitation completion.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12618001547235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375945.

Keywords: digital health; heart failure; ischemic heart disease; mHealth; mobile phone; telemedicine.

Figure 1

Screenshots of the TeleClinical Care (TCC) app. From left to right: the TCC app home screen, the appearance of an educational notification, weekly record of blood pressure readings, and weekly record of weight readings.

Figure 2

Bluetooth-enabled peripheral devices. From left to right: sphygmomanometer (A&D Medical UA-651BLE), weighing scale (A&D Medical UC-352BLE), and activity monitor (Xiaomi MiBand 2).

Figure 3

Screenshot of the KIOLA back-end, which is visible to monitoring clinicians. Blood pressure and pulse rate are recorded when the data are sent from the Bluetooth-enabled sphygmomanometer. Readings outside the shaded zone automatically trigger an email alert to the monitoring clinicians. Bpm: beats per minute.

Figure 4

Enrollment flowchart.

Figure 5

Cumulative readmissions over the course of the trial. TCC: TeleClinical Care.

Figure 6

Cost-Effectiveness of the TeleClinical Care model as described by total costs incurred by the system and total costs saved by projected cardiac readmission prevention. The x-axis represents the number of patients enrolled, and the y-axis represents the cost in millions of Aus $.