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.

Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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 pat CONDITION: Cardiovascular ‐ Coronary heart disease Myocardial infarction (MI) ;Decompensated heart failure (HF) ; ; Myocardial infarction (MI) ; Decompensated heart failure (HF) PRIMARY OUTCOME: Rate of unplanned hospital readmission at 6 months using patient medical records and linked health administrative data.[At 6 months post randomisation.] INCLUSION CRITERIA: 1. Patient at point of discharge from hospital with one of the following primary diagnoses: a. Myocardial infarction (MI) type 1 b. Decompensation of Heart Failure (DHF), including heart failure with preserved left ventricular ejection fraction The Fourth universal definition of type 1 MI is defined as a rise and/or fall in cardiac Troponin with at least 1 value above the 99th percentile upper reference limit in conjunction with one or more of the following: symptoms of acute myocardial ischaemia; new ischaemic ECG changes; development of pathological Q waves; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology. 2. Aged over 18 years. 3. Able to provide written informed consent. SECONDARY OUTCOME: Cardiac rehabilitation completion rates using patient medical records[From baseline to 6 months post randomisation. ] Cardiac rehabilitation participation rates using patient medical records[From baseline to 6 months post randomisation. ] Composite of death, myocardial infarction, stroke, unplanned coronary revascularisation and unplanned hospital readmission at 30 days, 6 and 12 months using patient medical records and linked health administrative data. [At 30 days, 6 and 12 months post randomisation] Cost effectiveness of the TCC‐Cardiac solution through calculation of (i) resource intervention costs (e.g. devices, Research Nurses, SMS delivery); (ii) health care costs and (iii) use of services and products collected via questions to participants at 6‐month follow‐up.[At 6 month follow‐up, post randomisation and end of study. ] Death using patient medical records and linked health administrative data.[30 days, 6 and 12months post randomisation ] For Cohort 1 only: Change in blood pressure using patient medical records.[From baseline to 6 months post randomisation.] For Cohort 1 only: Change in BMI using patient medical records.[From baseline to 6 months post randomisation.] For Cohort 1 only: Change in exercise capacity using 6‐minute walk test.[From baseline to 6 months post randomisation.] For Cohort 1 only: Change in fasting low density lipoprotein using patient medical records[From baseline to 6 months post randomisation. ] For Cohort 1 only: Change in health related quality of life using Short Form Health Survey, SF12.[From baseline to 6 months post randomisation.] For Cohort 1 only: Change in high‐density lipoprotein levels using patient medical records.[From baseline to 6 months post randomisation. ] For Cohort 1 only: Change in high‐density lipoprotein levels using patient medical records.[From baseline to 6 months post randomisation.] For Cohort 1 only: Change in waist/hip circumference using patient medical records.[From baseline to 6 months post randomisation.] For Cohort 1 only: Changes in mental wellbeing using depression, anxiety (PHQ‐8) and wellbeing (COMPAS‐W) questions.[From baseline to 6 months post randomisation.] Incidence of myocardial infarction using patient medical records and linked health administrative data.[30 days, 6 and 12months post randomisation using patient medical records.] Incidence of stroke using patient medical records and linked health administrative data.[30 days, 6 and 12months post randomisation.] Incidence of unplanned coronary revascularisation using patient medical records and linked health administrative data. [30 days, 6 and 12months post randomisation.] Maximum doses of recommended medications using patient medical records and data linkage[At 6 and 12 months post randomisation] Prescription of guideline recommended medications using patient medical records and data linkage.[At 6 and 12 months post randomisation] Unplanned cardiac hospital readmissions at 30 days, 6 and 12 months using patient medical records and linked health administrative data. [At 30 days, 6 and 12 months post randomisation] Unplanned hospital readmission using patient medical records and linked health administrative data.[30 days, 6 and 12months post randomisation.]
Epistemonikos ID: 0629b14b7f28fd096b0b8c3151f312adaa9fc8de
First added on: Aug 25, 2024