Tele-Clinical Care Cardiac (TCC-Cardiac): Evaluating the effectiveness and safety of a smartphone application-centric model of care and its patient messaging component as standalone (TCC-Text), as an adjunct to usual care in patients who are being discharged home following an acute cardiac event, for the secondary prevention of cardiovascular events.

Patients admitted with myocardial infarction (MI) or decompensated heart failure (HF) being discharged home will be allocated to 1 of 3 cohorts, using predefined criteria according to their access to technology in a pragmatic design as follows: Cohort 1: Have a mobile phone and it is a smartphone that is compatible with the TCC-Cardiac app Cohort 2: Have a mobile phone, but is NOT a smartphone compatible with the TCC-Cardiac app Cohort 3: Do not have a mobile phone Cohort 1 patients will be randomised at point of hospital discharge in a 1 to 1 ratio to the TCC-Cardiac program in addition to usual care (Cohort 1a), or to usual care alone (Cohort 1b). Cohort 2 patients will be randomised 1 to 1 to receive supportive text messages (TCC-Text) in addition to usual care (Cohort 2a), or to usual care alone (Cohort 2b). Cohort 3 is a registry of patients discharged home per usual care. Cohort 1a participants randomised to intervention will receive access and support to use the TCC-Cardiac app, as well as wireless devices (where available) for measuring blood pressure, pulse rate and weight. HF patients will also receive a device for measuring oxygen saturation. The wireless devices will enable the data to be automatically transmitted to the application. The study team at each participating site will assist these participants to download the TCC Cardiac app on their mobile phones, provide instructions on how to use the app and to pair it with the peripheral devices. This should take approximately 15 minutes. Additionally, a hard copy pamphlet explaining the app and the peripheral devices will be provided to the participant during the training which will also be available electronically via a website. On the website, there will also be a more detailed patient guide with sections on troubleshooting issues and whom to contact for queries. Manual data entry will take place for participants who are not provided a Bluetooth device (due to lack of availability). Participants will be required to provide data daily (where possible). The process will take less than 5 minutes per day. Participants will be requested to enter data daily for a total of 6 months. The intervention is administered by a multicentre research team comprising doctors, nurse practitioners and nurses at the local hospital that the participant is cared for at. Adherence to the intervention can be measured by analysis of the data, as all transmitted readings are available to the research team to view. TCC-Cardiac App: The TCC-Cardiac App is a smartphone application-centric model of care that combines evidence-based best practice with recent advances in mobile technology to enhance the delivery of a behavioural and exercise program to prevent recurrent cardiovascular events. The TCC-Cardiac App pairs wirelessly to personal peripheral devices including a blood pressure monitor, pulse oximeter (in HF patients) and weight scales, to record pulse rate, blood pressure, oxygen saturation (in HF patients) and weight. It measures physical activity via the smartphone’s innate activity tracker, or in the event the patient has one, a personal wearable device. Additional TCC-Cardiac app features include medication reminders and measurement of compliance, a tailored virtual exercise programme, persuasive design elements to deliver notifications and education to encourage and reinforce self-efficacy and healthy behaviours including physical activity, smoking reduction and healthy eating. The eight week exercise program through the app includes three levels of exercise regimens, focused on strength and endurance exercises. All patients will be offered face-to-face cardiac rehabilitation as part of their usual care. KIOLA: The data is collected and displayed in an intuitive, user-friendly format on the patient’s phone app, and transferred to KIOLA, a central, secured web-based server located at UNSW. It will comprise a clinician dashboard with data analytics features for monitoring and triaging incoming patient data. All incoming data collected by the peripheral devices and smartphone application will be transmitted to the KIOLA server. Here, the investigators will monitor for abnormalities in the data such as: trajectories of weight gain, excessive rise or fall in blood pressure or fall in medication compliance. If a concerning abnormality is detected, the participant will be contacted directly and asked to schedule a visit with their general practitioner, cardiologist or cardiac nurse. In situations where the biometric data indicate a rapidly worsening trajectory or the need for urgent assessment and/or treatment, the participant would be recommended to attend the emergency department. Access to KIOLA can be provided to the participant’s healthcare providers, such as general practitioners, if the patient provides permission for this. These healthcare providers will have custom accounts made that only allows access to the data for their own patients. They will be informed that the responsibility for responding to alerts will firstly be that of the research team, who may choose to contact them if required. The remote monitoring research team will monitor participant’s vitals and alerts and also provide level one technical support. TCC-text: a text messaging-based mHealth Intervention TCC-text is a text messaging intervention designed for mHealth delivery to patients with mobile phones that are not compatible with the TCC-Cardiac smartphone application (Cohort 2a). This system is delivered from the same KIOLA back-end as TCC-Cardiac and allows for the intermittent delivery of health statements to prompt behaviour change aligned to the NSW Heart Foundation Managing My Heart Health consumer resource. The messages are tailored to the individual patient (e.g. diagnosis, smoking status) and varied according to time from discharge. The messages will be identical to the notifications received by patients in Cohort 1a. These messages will be delivered three times a week and will be identical to the notifications received by patients in Cohort 1a. KIOLA will be used to monitor and record delivery of text messages. Interventions are adjunct to usual care.