Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000754842
Ethics application status
Approved
Date submitted
18/04/2021
Date registered
16/06/2021
Date last updated
6/07/2022
Date data sharing statement initially provided
16/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
TeleClinical Care Cardiac (TCC-Cardiac): Efficacy and safety of adjunctive virtual models of care in the secondary prevention of cardiovascular events in adults discharged from hospital after myocardial infarction or decompensated heart failure.
Secondary ID [1] 304278 0
Nil unknown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction (MI) 321602 0
Decompensated heart failure (HF) 321603 0
Condition category
Condition code
Cardiovascular 319342 319342 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320296 0
Prevention
Intervention code [2] 320297 0
Behaviour
Comparator / control treatment
Patients in cohorts 1 and 2 randomised to usual care and the cohort 3 registry will receive usual care alone. Usual care will be determined by each patient’s primary cardiac physician at each site. Usual care will standardly include follow-up by their GP and cardiologist, referral as appropriate to local cardiac rehabilitation services and a referral to the NSW Get Healthy programme.
Control group
Active

Outcomes
Primary outcome [1] 327210 0
Rate of unplanned hospital readmission at 6 months using patient medical records and linked health administrative data.
Timepoint [1] 327210 0
At 6 months post hospital discharge
Secondary outcome [1] 394219 0
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.
Timepoint [1] 394219 0
At 30 days, 6 and 12 months post hospital discharge
Secondary outcome [2] 395826 0
Death using patient medical records and linked health administrative data.
Timepoint [2] 395826 0
30 days, 6 and 12 months post hospital discharge
Secondary outcome [3] 395827 0
Incidence of myocardial infarction using patient medical records and linked health administrative data.
Timepoint [3] 395827 0
30 days, 6 and 12 months post hospital discharge using patient medical records
Secondary outcome [4] 395828 0
Incidence of stroke using patient medical records and linked health administrative data.
Timepoint [4] 395828 0
30 days, 6 and 12 months post hospital discharge
Secondary outcome [5] 395829 0
Incidence of unplanned coronary revascularisation using patient medical records and linked health administrative data.
Timepoint [5] 395829 0
30 days, 6 and 12 months post hospital discharge
Secondary outcome [6] 395830 0
Unplanned hospital readmission using patient medical records and linked health administrative data.
Timepoint [6] 395830 0
30 days, 6 and 12 months post hospital discharge
Secondary outcome [7] 395831 0
Unplanned cardiac hospital readmissions at 30 days, 6 and 12 months using patient medical records and linked health administrative data.
Timepoint [7] 395831 0
At 30 days, 6 and 12 months post hospital discharge
Secondary outcome [8] 395832 0
Cardiac rehabilitation participation rates using patient medical records
Timepoint [8] 395832 0
From baseline to 6 months post hospital discharge.
Secondary outcome [9] 395833 0
Cardiac rehabilitation completion rates using patient medical records
Timepoint [9] 395833 0
From baseline to 6 months post hospital discharge.
Secondary outcome [10] 395834 0
Prescription of guideline recommended medications using patient medical records and data linkage.
Timepoint [10] 395834 0
At 6 and 12 months post hospital discharge.
Secondary outcome [11] 395835 0
Maximum doses of recommended medications using patient medical records and data linkage
Timepoint [11] 395835 0
At 6 and 12 months post hospital discharge.
Secondary outcome [12] 395926 0
For Cohort 1 only: Change in fasting low density lipoprotein using patient medical records
Timepoint [12] 395926 0
From baseline to 6 months post hospital discharge.
Secondary outcome [13] 395927 0
For Cohort 1 only: Change in high-density lipoprotein levels using patient medical records.
Timepoint [13] 395927 0
From baseline to 6 months post hospital discharge.
Secondary outcome [14] 395928 0
For Cohort 1 only: Change in blood pressure using patient medical records.
Timepoint [14] 395928 0
From baseline to 6 months post hospital discharge.
Secondary outcome [15] 395929 0
For Cohort 1 only: Change in high-density lipoprotein levels using patient medical records.
Timepoint [15] 395929 0
From baseline to 6 months post hospital discharge.
Secondary outcome [16] 395930 0
For Cohort 1 only: Change in waist/hip circumference using patient medical records.
Timepoint [16] 395930 0
From baseline to 6 months post hospital discharge.
Secondary outcome [17] 395931 0
For Cohort 1 only: Change in BMI using patient medical records.
Timepoint [17] 395931 0
From baseline to 6 months post hospital discharge.
Secondary outcome [18] 395932 0
For Cohort 1 only: Change in health related quality of life using Short Form Health Survey, SF12.
Timepoint [18] 395932 0
From baseline to 6 months post hospital discharge.
Secondary outcome [19] 395933 0
For Cohort 1 only: Change in exercise capacity using 6-minute walk test or the 1-minute sit to stand test
Timepoint [19] 395933 0
From baseline to 6 months post hospital discharge
Secondary outcome [20] 395934 0
For Cohort 1 only: Changes in mental wellbeing using depression, anxiety (PHQ-8) and wellbeing (COMPAS-W) questions.
Timepoint [20] 395934 0
From baseline to 6 months post hospital discharge.
Secondary outcome [21] 395935 0
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.
Timepoint [21] 395935 0
At 6 month follow-up post hospital discharge and end of study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitive impairment – as measured by the 10-point Abbreviated Mental Test (AMT-10 less than 8).

2. Terminal illness – in the opinion of the site investigator, the participant has an illness that will result in death within the next 12 months.

3. Non-English speaking

4. Patients who plan to travel overseas within the first 30 days of joining the study.

5. Enrolled in another active study

6.High chance in the opinion of the investigator that the potential participant will not or cannot adhere to study requirements

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Randomisations will be stratified by primary diagnosis (HF vs MI) and study site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/06/2021
Actual
16/07/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
2500
Accrual to date
307
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19143 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 19144 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 19145 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [4] 19146 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 19147 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [6] 19148 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 19149 0
St George Hospital - Kogarah
Recruitment hospital [8] 19150 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [9] 19151 0
Wollongong Hospital - Wollongong
Recruitment hospital [10] 22760 0
Concord Repatriation Hospital - Concord
Recruitment hospital [11] 22761 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 33705 0
2031 - Randwick
Recruitment postcode(s) [2] 33706 0
2229 - Caringbah
Recruitment postcode(s) [3] 33707 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 33708 0
2170 - Liverpool
Recruitment postcode(s) [5] 33709 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 33710 0
2065 - St Leonards
Recruitment postcode(s) [7] 33711 0
2217 - Kogarah
Recruitment postcode(s) [8] 33712 0
2010 - Darlinghurst
Recruitment postcode(s) [9] 33713 0
2500 - Wollongong
Recruitment postcode(s) [10] 38037 0
2139 - Concord
Recruitment postcode(s) [11] 38038 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 308371 0
Government body
Name [1] 308371 0
NSW Ministry of Health
Country [1] 308371 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 309188 0
None
Name [1] 309188 0
Address [1] 309188 0
Country [1] 309188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308337 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 308337 0
Research Directorate
Locked Bag 7279
Eastern Campus
Liverpool BC NSW 1871
Ethics committee country [1] 308337 0
Australia
Date submitted for ethics approval [1] 308337 0
25/11/2020
Approval date [1] 308337 0
24/02/2021
Ethics approval number [1] 308337 0
2020/ETH03062

Summary
Brief summary
This is a prospective, multicentre pragmatic, randomised trial. The primary objective is to examine the impact of the TCC-Cardiac solution compared with usual standard care alone on 6-month unplanned hospital readmission rates in patients who have recently been discharged following an acute cardiac event including myocardial infarction and decompensated heart failure. Participants 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 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: 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 is a registry of patients discharged home per usual care.
We will aim to recruit 2500 patients aged above 18 years, comprising 1000 patients in the main randomisation (Cohort 1), 1000 patients randomised in cohort 2 and 500 patients in the cohort 3 registry.
Based on a pilot study’s results, it is hypothesised that the Teleclinical Care (TCC) app will lead to a reduction in readmission rates and improvement in clinical indices associated with clinical outcome in patients with myocardial infarction and decompensated heart failure.
Trial website
https://www.ihealthe.unsw.edu.au/research/tcc-cardiac
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110354 0
Dr Sze Yuan Ooi
Address 110354 0
Prince of Wales Hospital
320 Barker St
Randwick
NSW 2031
Country 110354 0
Australia
Phone 110354 0
+61 296504959
Fax 110354 0
Email 110354 0
[email protected]
Contact person for public queries
Name 110355 0
Dr Sze Yuan Ooi
Address 110355 0
Prince of Wales Hospital
320 Barker St
Randwick
NSW 2031
Country 110355 0
Australia
Phone 110355 0
+61 296504959
Fax 110355 0
Email 110355 0
[email protected]
Contact person for scientific queries
Name 110356 0
Dr Sze Yuan Ooi
Address 110356 0
Prince of Wales Hospital
320 Barker St
Randwick
NSW 2031
Country 110356 0
Australia
Phone 110356 0
+61 296504959
Fax 110356 0
Email 110356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Medical data pertaining to an individual will not be made public. Only aggregate summary data will be published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.