TCC Cardiac

TCC Cardiac Logo

Overview

TCC Cardiac is an NSW Health-funded study that will examine the comparative efficacy of the TeleClinical Care - Cardiac solution comprising of a smartphone application, backend clinician dashboard and associated model of care, and its messages component as standalone, as an adjunct to usual standard care in patients who are being discharged home following an acute cardiac event.

The Team

Collage of TCC Cardiac Team Member Portraits

Governance

TCC Cardiac Governance Workflow

Partners & Collaborators

This study is being conducted by The University of New South Wales in collaboration with a range of organisations.

Co-Chief Investigator Dr Sze Yuan Ooi, Prince of Wales Hospital, University of New South Wales
Co-Chief Investigator Emeritus Professor Nigel Lovell, Graduate School of Biomedical Engineering, University of New South Wales
Lead Site Principal Investigator Dr Praveen Indraratna, Prince of Wales Hospital
Steering Committee Members Professor Louisa Jorm, University of New South Wales
Professor Teng Liaw, University of New South Wales
Dr Nancy Briggs, University of New South Wales
Professor Branko Celler, University of New South Wales
Dr Peter Brown, University of New South Wales
Professor Gemma Figtree, University of Sydney
Professor Robyn Gallagher, University of Sydney
Professor Stephen Jan, The George Institute for Global Health
Dr Hueiming Liu, The George Institute for Global Health
Professor David Peiris, The George Institute for Global Health
Professor Kim Delbaere, NeuroScience Research Australia

Study Sites

  1. Prince of Wales Hospital – Active
  2. Port Macquarie Base Hospital - Active
  3. St Vincent's Hospital Sydney - RGO Approved
  4. The Sutherland Hospital - RGO Approved
  5. Royal North Shore Hospital - Pending
  6. Wollongong Hospital - Pending RGO Approval
  7. Coffs Harbour Health Campus - Pending
  8. Liverpool Hospital - Pending RGO Approval
  9. John Hunter Hospital - Pending
  10. St George Hospital - Pending

Interventions

(1) 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 behavioral and exercise program to prevent recurrent cardiovascular events.

(2) Backend Clinician Dashboard - data collected from the patient’s phone app is transferred to KIOLA, a central web-based server which comprises a clinician dashboard with data analytics features for monitoring and triaging incoming patient data. Investigators may monitor for abnormalities in the physiological data such as: weight gain, hypertension, hypotension and hyoxaemia.

(3) Collaborative Care Model:

Collaborative Care Model - Flowchart
Collaborative Care Model - Smartphone Application

The intervention will be evaluated by a prospective, multi-centre pragmatic trial. 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, including 1) TCC-Cardiac randomisation, 2) TCC-text randomisation, or 3) usual care registry.

Cohort 1 (N=1,000): patients will be randomised at point of hospital discharge in a 1:1 ratio to the TCC-Cardiac program in addition to usual care, or to usual care alone.

Cohort 2 (N=1,000): patients will be randomised 1:1 to receive supportive text messages (TCC-Text) in addition to usual care, or to usual care alone.

Cohort 3 (N=500) is a registry of patients.

Resources

For Participants

News

Recruitment Update

  • We are pleased to announce that we have reached and exceeded the milestone of 100 patients enrolled into TCC-Cardiac! This is a great effort by all recruiting sites, in particular our lead study site, Prince of Wales Hospital, led by Dr. Praveen Indraratna and the team, who have contributed a total of 111 participants into the study so far. Keep up the good work everyone!
  • Our newest site, Port Macquarie Base Hospital, led by Dr. Chris Alexopoulos, have commenced patient enrolment on 17th November 2021. They currently have 8 participants randomised into the study and are recruiting well.
  • St Vincent’s Hospital, Sydney, led by Prof. Chris Hayward, and The Sutherland Hospital, led by Dr. Matthew Allan, have both received RGO Approval and are in the final stages of site activation. We hope to begin recruiting at these sites very soon.
  • We have initiated 3 other sites in the past few months and are in the various stages of Research Governance submissions. These are:
    • Wollongong Hospital, led by Dr. Pratap Shetty
    • Royal North Shore Hospital, led by Prof. Gemma Figtree
    • Liverpool Hospital, led by Prof. Craig Juergens

Protocol Update (v5 to v6)

  • An amendment to the Protocol (v5 to v6) has been submitted to SWSLHD HREC to include an additional assessment in the Schedule of Assessments – the 1-Minute Sit-to-Stand Test (1-MSTST). The 1-MSTST typically involves an armless chair and the performance of as many sit-to-stand actions as possible in 1 min without using the upper limbs. This is a validated test and it will be conducted as an alternative for patients who are unable to complete the 6 Minute Walk test (6-MWT). For those who are able to undertake both tests (1-MSTST and 6 MWT), a short break between the two tests will be advised to avoid fatigue.
  • This amendment will require submission to your Research Governance Offices, including a new Patient Information Sheet and Consent Form and TCC-Cardiac Study Pamphlet.

FAQs & Tips

  • DAG v Enrolling Sites: You may notice some patients are listed in your REDCap Dashboard without enrolling them. For example a patient may be enrolled at Prince of Wales and then transferred back to Port Macquarie where they reside. Within Redcap itself, these patients are listed under their Data Access Group (DAG) site, rather than their enrolling site. An alert will be issued to the DAG site when a patient is enrolled at another hospital. Reports will also be sent to each DAG site on a regular basis listing all their Cohort 1 patients and their expected dates for 6 monthly follow up. The follow up fee will be paid to the DAG site.
  • Forms A, B and C - Alert Management: You would have received an email regarding your site’s Alert Management Plan. Form A is used to document how alerts will be responded to at your site once received from the Remote Monitoring Solution (RMS) team. Form B lists all healthcare professionals that will form part of a patient’s care circle and who will require access to the KIOLA Dashboard. This form will also capture who, at your site, will receive alert notifications from the Remote Monitoring Solution (RMS) Team in the event of a red, yellow or exercise alert. Forms A & B should be completed prior to enrolling patients. Form C is for use by treating cardiologists who may wish to modify their individual patient’s default thresholds within KIOLA.
  • GPs and Private Cardiologist Referral Letters: GPs and Cardiologists will be able to participate in the care of their patients and can opt to have access to their patient data in the KIOLA backend. The GP Letter and Cardiologist Referral letters are uploaded to your site folders on MS Teams. These are to be provided to the patients at discharge and advised to hand to their respective treating doctors.
  • For more information about any of the above, please contact Bridie Vaughan bvaughan@georgeinstitute.org.au.

The festive season is fast approaching. For holiday closure dates see below:

RMS will be operating during the holiday period, except for all public holidays (25th-28th December & 3rd January). During this time, please inform all Cohort 1a patients that RMS will not be monitoring their data during this period and to contact 000 in an emergency.

The George Institute will be closed on 25th December – 3rd January (inclusive). Any urgent operational issues during this time should be referred to SESLHD-TCC-Cardiac@health.nsw.gov.au

After a great effort by the project team, we are very excited to announce that TCC-Cardiac has received regulatory and ethics approvals to begin!

  • We have set up our lead site Prince of Wales Hospital, led by Dr Jennifer Yu, and the team randomised their first patient on 16th July! Currently a total of 29 patients have been randomised into the study.
  • The Site Initiation Visit has been completed for Port Macquarie Base Hospital on 18th August. We are looking to begin enrolment at that site very soon.
  • Other sites are undergoing ethics approval and we hope to begin site start-up procedures with you soon.
  • Participants in the TCC-Cardiac study will be referred to the Get Healthy program: https://www.gethealthynsw.com.au/get-started/.
  • GPs and private cardiologists will also be able to participate in the care of their patients, who can opt to have access to their patient data in the KIOLA backend.
  • We will soon submit an amendment to version 4 of the protocol to include two additional exclusion criteria – (i) ‘actively receiving any intervention in another study’ and (ii) High chance in the opinion of the investigator that the potential participant will not or cannot adhere to study requirements. This is to ensure participants from the TCC Heart Failure study and similar studies are not enrolled into TCC-Cardiac. The other amendment is the replacement of quality of life questionnaires EQ 5D 5L and WHO DAS assessments with Short Form 12 Survey. SF12 is a more sensitive survey (in this study’s population) to use for the health economic analysis. The EQ-5D-5L score was found not to be very discriminating in the TCC pilot population. We will keep you updated on the progress of this amendment.

Contact

TCC Cardiac and the University of New South Wales do not conduct services direct to the public. Please consult your doctor should you have any concerns about your health.

For all enquiries, please email SESLHD-TCC-Cardiac@health.nsw.gov.au or complete the form below. Fields marked with an asterisk (*) are required.