A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
Phase: NA
Conditions: Coronary Artery Disease, Chronic Disease, Nurse's Role
Sponsor: Baker Heart and Diabetes Institute

                                                                                                                                                                                             
 
 
 
 
 
 
 
 
 
 
 
 
A risk-guided disease management and tele-rehabilitation program to 
reduce re-admissions in coronary artery disease (Risk-Guided CAD) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL 
Version 1.2; 19 May 2021 
 
 
 
 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
 
RISK-GUIDED CAD INVESTIGATORS 
 
Principle Investigators 
Associate Professor Melinda Carrington 
 
Co- Investigators 
Professor Tom Marwick 
Dr Quan Huynh 
Associate Professor Jo-Anne Manski-Nankervis 
Professor Brian Oldenburg 
Dr Dominika Kwasnicka 
Dr Erin Howden 
Professor Garry Jennings 
Professor David Thompson 
Dr Deepak Haikerwal 
 
 
FUNDING 
The Study is supported by the following research grants awarded to the Study Investigators from 2021 to 
2024: 
i. 
Heart Foundation Vanguard Grant (APP ID: 104773) 
ii. HCF Research Foundation 
iii. Baker Department of Cardio-metabolic Health 
iv. Perpetual IMPACT funding (IPAP 2020/0606) 
 
 
CLINICAL TRIAL REGISTRATION 
The Risk-Guided CAD study is registered with the Australian New Zealand Clinical Trials Registry 
(ANZCTR No. TBA).  
 
 
ETHICS 
Ethics approval was obtained from the Alfred Hospital Ethics Committee (Project number 266/21).  
 
 
 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
TABLE OF CONTENTS 
 
FUNDING.............................................................................................................................................. 2 
CLINICAL TRIAL REGISTRATION ....................................................................................................... 2 
ETHICS ................................................................................................................................................. 2 
 
1. 
SUMMARY ................................................................................................................................. 5 
2. 
BACKGROUND .......................................................................................................................... 5 
2.1 
CAD is the greatest cause of morbidity and mortality in Australia ................................... 5 
2.2 
Health disparities are greatest among low socioeconomic populations .......................... 5 
2.3 
Secondary prevention models of care .............................................................................. 6 
2.4 
Using digital technology to strengthen DMPs................................................................... 6 
2.5 
Risk guidance of secondary prevention ............................................................................ 6 
3. 
AIMS ........................................................................................................................................... 7 
4. 
HYPOTHESIS ............................................................................................................................. 7 
5. 
STUDY DESIGN ......................................................................................................................... 7 
6. 
END POINTS .............................................................................................................................. 8 
6.1 
Primary end-point............................................................................................................. 8 
6.2 
Secondary end-points ....................................................................................................... 8 
7. 
RECRUITMENT .......................................................................................................................... 8 
8. 
ELIGIBILITY ................................................................................................................................ 8 
9. 
RANDOMISATION...................................................................................................................... 9 
10. 
PROCEDURES .......................................................................................................................... 9 
10.1 Risk evaluation.................................................................................................................. 9 
10.2 Baseline measures ............................................................................................................ 9 
11. 
FOLLOW-UP PROCEDURES .................................................................................................. 10 
12. 
INTERVENTION GROUP – DISEASE MANAGEMENT PROGRAM........................................ 11 
12.1 Nurse care planning and health coaching ....................................................................... 11 
12.2 eHealth strategies ........................................................................................................... 12 
13. 
CONTROL GROUP .................................................................................................................. 14 
14. 
STUDY TIMELINE .................................................................................................................... 14 
15. 
STUDY POWER ....................................................................................................................... 14 
16. 
STATISTICAL ANALYSES ....................................................................................................... 14 
17. 
REFERENCES ......................................................................................................................... 15 
 
 
 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
Table 1: Study outline 
 
 
 
Follow-up 
 
Screen 
Baseline 
visit 
30 days 
90 days 
12 month 
visit 
 
 
 
 
 
 
Eligibility (inclusion/exclusion) 
X 
 
 
 
 
Informed consent 
X 
 
 
 
 
PEGASUS-TIMI 541 risk evaluation 
X 
 
 
 
 
Medical background 
X 
X 
 
 
 
Randomisation 
 
X 
 
 
 
Questionnaires 
 
X 
 
 
X 
Clinic assessment 
 
X 
 
 
X 
Venous blood sample 
 
X 
 
 
X 
Exercise capacity 
 
X 
 
 
X 
Physiology/cardiac function 
(echocardiography) 
 
X 
 
 
X 
Quality of care assessment 
 
 
 
X 
 
Outcome data 
 
 
X 
(medical 
record review) 
X 
(medical 
record review) 
X 
 
 
 
 
 
 
 
 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
1. 
SUMMARY 
Coronary artery disease (CAD) is a major cause of ill health in Australia and is an expensive disease 
group to treat owing to costly hospital readmissions. Many of these readmissions can be prevented with 
improved management following a diagnosis of CAD. The need to achieve effective secondary 
prevention is likely to remain as great or increase as a consequence of the COVID-19 pandemic. 
Therefore, predicting higher risk patients with the greatest likelihood of recurrent ischaemic events 
permits targeting of chronic disease management programs to reduce hospital readmissions. 
Disease Management Programs (DMP) and cardiac rehabilitation programs are known to improve long-
term cardiovascular outcomes and quality of life. However current approaches to traditional models 
have tended to be insufficient and during COVID-19, the practice of social isolation has disrupted the 
typical delivery and access to routine health care. e-Health and medical-related apps offer a valuable 
addition for patient care and for enhancing health service delivery. Integrating digital solutions with 
nurse management will maintain access to secondary prevention, whilst minimising COVID-19 
exposure and providing benefit to those living in areas where residents have greater risk factor burden 
and socioeconomic disadvantage. 
 
2. 
BACKGROUND 
2.1 
CAD is the greatest cause of morbidity and mortality in Australia 
CAD remains the number one killer of Australians2, is among the most expensive disease groups to 
treat3 and continues to be a disease burden4. CAD accounts for almost half of all cardiovascular disease 
(CVD) deaths and nearly one third of CVD-related hospitalisations5. Readmissions to hospital for CAD 
patients are among the highest of any disease; our CIs showed, using contemporary data from a 
Queensland state-wide linkage study of ≈140,000 CVD patients, that 37% of CAD patients were 
readmitted within 90 days post discharge (Table 1). This rate was greatest for younger patients of 
working age (i.e. <65 years). CAD results in the biggest productivity losses due to death and 
absenteeism compared to other types of CVD. 
 
Table 1. 90-day readmission rates for major types of CVD in Queensland (2010) 
Condition type 
90 day readmission 
(all) 
90 day readmission 
(aged <65 years) 
Coronary artery disease 
37% (n=7,396) 
42% (n=8,439) 
Heart Failure 
49% (n=1,889) 
13% (n=511) 
Stroke 
33% (n=559) 
38% (n=636) 
 
2.2 
Health disparities are greatest among low socioeconomic populations 
CVD affects people from lower socioeconomic groups more than people from higher socioeconomic 
groups. In general, population data show that individuals from the lowest socioeconomic groups (i.e. 
greatest disadvantage) have higher rates of chronic conditions, a shorter life expectancy, more health 
risk factors and a greater burden of disease than people in the highest groups (of least disadvantage)6.  
The local government area of Wyndham (south-west of Melbourne) 7, whereby the Baker has 
established a clinical trials research facility, has a moderate level of relative socio-economic 
disadvantage. Compared to Greater Melbourne in 2016, fewer people in Wyndham had a Bachelor or 
Higher degree qualification (24.4% vs. 27.5%), had completed year 12 (or equivalent) schooling (58.2% 
vs. 59.4%), owned their own home (19.2% vs. 29.0%) and more people were unemployed (8.2% vs. 
6.8%) and had a mortgage (46.3% vs. 34.3%). Wyndham is identified as a heart attack hot spot, in part 
due to8: 
 Being overweight and obese - 83% compared to Victorian average 51% [32% higher] 
 Being insufficiently physical active - 56% compared to Victorian average 44% [12% higher] 
 Smoking - 21% compared to Victorian average 17% [4% higher]. 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
2.3 
Secondary prevention models of care 
Nurses can play a key role in providing case management in secondary prevention, with potential cost-
savings via reduced and fewer days of hospitalisation. In heart failure, implementation of DMPs when 
transitioning from hospital to home can have clinical benefit through reduced hospital readmissions and 
mortality and improved standards and knowledge of health. These findings emphasise that nurse-led 
case management could be an effective strategy for managing patients. 
Cardiac rehabilitation (CR) programs have demonstrated significant evidence of benefit on mortality, 
re-hospitalisation, psychological wellbeing, quality of life and CVD risk factors. However, traditional 
models for delivery of secondary prevention and CR programs are increasingly problematic, especially 
following the advent of COVID-19, and do not suit younger, busy, remote and/or socially isolated 
individuals. . To improve the current poor participation rates, different strategies for delivering CR 
programs using e-Health have emerged. In a systematic review, it was concluded that there was no 
need to rely on traditional hospital-based CR alone to deliver effective CR and community-based 
programs could be just as effective9. The COVID-19 pandemic has also disrupted traditional face-to-
face program delivery. COVID-19 has affected patients’ visits to health care professionals, clinical 
testing (e.g. imaging), pathology and attendance for CR.  However, patients with CAD must still continue 
to receive management and support. Novel modalities of providing secondary prevention and CR can 
be enabled by e-Health and telehealth strategies thereby overcoming some of the barriers to the 
traditional delivery of health care delivery. 
 
2.4 
Using digital technology to strengthen DMPs 
E-Health and medical-related apps offer a valuable adjunct for patient care and for enhancing health 
service delivery which is convenient, low cost and has broad population reach. Smartphones and digital 
devices are entrenched in everyday life. A report by Deloitte found a majority of middle-aged Australians 
use smartphones or tablets (75% of those aged 50-64 years)10 and many users have downloaded and 
used a medical-related app11. In advanced chronic kidney disease, a smartphone-based self-
management system was feasible and clinically useful12 and in our own work using an avatar heart 
failure digital coach, patients had better knowledge, self-care and health related quality of life 
(unpublished data). These data give some assurance that integrating e-Health solutions with nurse 
management will improve patients’ access to secondary prevention programs. E-health and telehealth 
strategies could help overcome some of the barriers to routine health care by improving accessibility 
and uptake. The potential for this multi-component innovative model of care in clinical practice will be 
tested using the SmartCR app by Cardihab. 
 
2.5 
Risk guidance of secondary prevention 
In secondary prevention, the conventional 
risk assessment of a recurrent event/ 
rehospitalisation is that all patients are 
equally at high risk and should be treated 
similarly. However, risks are not distributed 
equally and may vary over time. Risk scores, 
such as the PEGASUS-TIMI 54 criteria1 to 
select higher risk patients with the greatest 
likelihood of recurrent ischaemic events, 
permits targeting of DMPs to reduce hospital 
readmissions. CIs Huynh and Marwick have 
shown greater reductions via intensified 
nurse 
intervention 
in 
heart 
failure 
readmissions or death in patients with the 
highest 
risk 
of 
short-term 
(30-day) 
readmission13 (Figure 1). More recently, 
these CIs have found from the Queensland 
state-wide linkage study that CAD patients at 
higher predicted risk stand to gain more from 
up-titration of cardio-protective therapies to target levels. Targeting DMPs to those most likely to benefit, 
 
Figure 1. Relationship between predicted and 
observed 30-day events13 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
whilst still providing care to lower acuity risk patients, facilitates the allocation of available resources to 
manage those at higher risk compared to expending resources on patients less likely to be readmitted. 
 
3. 
AIMS 
We aim to test a nurse-led, technology-enabled model of health care delivery, called Risk-Guided CAD, 
to reduce readmissions following CAD, thereby enhancing recovery and survivorship. The objectives 
are to assess: 
a. feasibility and acceptability of Risk-Guided CAD; 
b. effectiveness of Risk-Guided CAD in reducing readmissions or death after CAD 
 
4. 
HYPOTHESIS 
We envisage that a novel risk-guided DMP will be favourable to patients and associated with high-level 
participation. We hypothesise that high-risk patients randomised to Risk-Guided CAD will have reduced 
hospital readmissions or death compared with those randomized to usual care. 
 
5. 
STUDY DESIGN 
Risk-Guided CAD is an effectiveness and feasibility trial of a technology-enabled DMP to reduce 
hospital readmissions in CAD patients with greater socioeconomic disadvantage. 
Patients with CAD will be eligible to undergo risk-evaluation by the recruitment nurse, using a previously 
developed and validated risk score (PEGASUS-TIMI 54)1. Those classified as low-risk [score <6] will 
receive usual care (control group) consisting of the uniform application of a standard management plan. 
High-risk patients [score ≥6] according to PEGASUS-TIMI 54 criteria will be randomised to either usual 
care or a remote DMP (intervention group, our Risk-Guided CAD), (Figure 2). All participants will be 
assessed at baseline and 90 days (primary endpoint), with short-term and long-term follow-up at 30 
days and 12 months, respectively (secondary endpoints). 
 
Figure 2. Risk-Guided CAD study schema. 

Title: Risk-Guided CAD 
 
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6. 
END POINTS 
6.1 
Primary end-point 
The primary endpoint is unplanned all-cause readmission or death at 90 days post-discharge. 
 
6.2 
Secondary end-points 
A secondary endpoint will measure short-term unplanned all-cause readmission or death at 30 days 
post-discharge. 
Other secondary outcome measures will include changes in quality of life, exercise capacity and cardiac 
function at 12 months. Process evaluation (including uptake, adherence and completion rates) of our 
Risk-Guided CAD program will also be undertaken. SmartCR will be evaluated by measures of app 
engagement by quantifying data entry events and other indicators of program participation. 
 
7. 
RECRUITMENT 
Recruitment will occur via HeartWest cardiology clinics at the Baker Clinical Trials Research Centre in 
Wyndham. This facility provides health services for a geographic area where residents generally have 
greater CVD burden and socioeconomic disadvantage, and are the primary target population for this 
proposed research. HeartWest personnel (or authorised study personnel granted access) will routinely 
screen (2-3 times weekly) appointment bookings and discharge summaries to identify potentially eligible 
patients from the HeartWest database. This list will be provided to the study co-ordinator and eligible 
patients will be contacted by a Baker study team member via telephone to introduce and explain the 
study. For interested individuals, a letter of invitation and Participant Information and Consent Form 
(PICF) will be posted and these patients will be given 3-5 days to review and consider participation. A 
Baker study team member will make a telephone follow-up call to seek their interest to make an 
appointment to undergo a baseline visit, hopefully within 2 weeks post-discharge. At this visit, informed 
written consent will be obtained by the cardiac nurse. 
 
8. 
ELIGIBILITY 
Eligible patients are identified and selected according to the following criteria: 
Inclusion criteria: 
a. Aged between 30 to 74 years; AND 
b. Hospitalised (must be within 14 days post discharge) with CAD or other eligible cardiac 
procedure or condition including AMI (STEMI or NSTEMI), unstable angina, coronary artery 
bypass grafting or percutaneous coronary intervention; AND 
c. Defined as higher risk (score ≥ 6) by PEGASUS-TIMI 541 criteria 
d. Eligible for Medicare. 
 
Exclusion criteria: 
a. Inability to provide written informed consent; OR 
b. Non-English speaking; OR 
c. Inability to attend clinic visits; OR 
d. Inability to engage with an app due to low technical literacy or lacking access to a smartphone 
or wi-fi; OR 
e. Hospitalised with a primary diagnosis of heart failure; OR 
f. 
Requiring palliative care; OR 
g. Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. 
advanced malignancy); OR 
h. Participating in another study with a potential but unknown effect on outcome. 
 

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9. 
RANDOMISATION 
Using a pre-determined computer generated sequentially numbered randomisation schedule, eligible 
participants will be allocated in block sizes of 20 into one of two trial arms according to a 1:1 ratio. 
REDCap will be used to obtain the next random allocation to eliminate selection bias by concealing it 
from nurses. Due to the nature of the intervention, blinding participants and nurses will not be possible. 
 
10. 
PROCEDURES 
Risk-Guided CAD is an effectiveness and feasibility trial of a DMP to reduce hospital readmissions in 
CAD patients with greater socioeconomic disadvantage. We seek to do this by adopting innovative 
approaches to: 
a. a community-based secondary prevention DMP; 
b. supported by a novel e-Health app (SmartCR developed by CardiHab) to address components 
of a CR program; and 
c. selection of higher risk patients for appropriate management by validated (PEGASUS-TIMI 54) 
criteria1. 
 
10.1 Risk evaluation 
Patients will be stratified based on their level of predicted risk. PEGASUS-TIMI 54 criteria1 outlined in 
Table 2 will be used for selection of high risk patients with a score ≥6 (who have ~3-4 times higher risk 
of a secondary event than the remainder). 
 
Table 2. PEGASUS-TIMI 54 criterion and weighted scores 
 
Weighted score 
Age > 65 years 
2 
eGFR <60 ml/min/1.73m2 
2 
Prior AMI 
4 
Multi-vessel CAD 
3 
Diabetes mellitus 
2 
Maximum score 
13 
 
10.2 Baseline measures 
Eligible individuals will be invited to attend the Baker clinic at Wyndham to undergo a baseline 
assessment. Data will be collected by electronic questionnaire using REDCap and sent automatically 
to participants at specific time points, with assistance from a cardiac nurse, if required. Clinical 
assessments will be conducted by registered study nurses and specialist personnel: 
a. Medical background details will be abstracted from clinical records including –  
i. In-hospital details and assessment of clinical features (including severity and number of 
affected vessels); 
ii. Pathology (full blood count, renal function, liver function, troponin, lipid profile, HbA1C, B-
type natriuretic protein and hs-C-reactive protein); 
iii. Co-morbidities and CVD risk factors 
iv. Medications. 
 
b. Questionnaires - to determine: 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
i. Socio-demographic indicators: age, sex, marital status, living alone, language background, 
ethnicity, income and education. 
ii. Lifestyle factors: smoking, diet and alcohol. 
iii. Mental health: to assess depression via the Patient Health Questionnaire (PHQ-9) 14 and 
anxiety via the Generalised Anxiety Disorder Assessment (GAD-7) 15 
iv. Quality of life: via the Assessment of Quality of Life (AQoL-8D) 16 questionnaire. 
v. Questions about patient satisfaction and acceptability of the intervention (intervention 
participants only) will occur at 90 days post baseline. 
 
c. Health assessments -  
i. Clinical assessment: BP, heart rate, anthropometry (height, weight, BMI), abdominal and 
hip circumference and electrocardiogram (ECG), if not performed in hospital. 
ii. Pathology (intervention group only): any outstanding tests listed in 10.2.a.ii that were not 
collected as part of the index hospitalization (estimated 15-45 ml). At 4-6 weeks post-
hospitalisation, a lipid profile will be requested. 
iii. Mild cognitive impairment: assessed via the Montreal Cognitive Assessment 17. 
iv. Exercise capacity: via cardiopulmonary exercise testing and quantified as VO2 peak. 
Additional important prognostic markers will also be assessed including ventilatory 
efficiency (VE/VCO2 slope), heart rate reserve and recovery. 
v. Physiology/cardiac 
function 
(if 
not 
done 
in-hospital): 
via 
two-dimensional 
echocardiography (including left ventricular ejection fraction, left ventricular volume index, 
left atrial volume index, right atrial pressure, pulmonary arterial systolic pressure and 
estimated LV filling pressure (E/e’), using standard techniques and procedures18 
 
d. Process evaluation - will be conducted to assess contextual factors that may influence study 
outcomes, as well as intervention fidelity, maintenance and reach, consistent with Medical 
Research Council guidance19. 
i. Program fidelity: The cardiac nurse will record details of program delivery for each 
intervention patient; details of program use will also be available via the SmartCR app and 
from patients when they undergo their assessments. The number and proportion of patients 
engaging with the online CardiHab platform compared to personalised exercise program 
sessions will be determined. Attendance and topics addressed at telehealth appointments 
will be recorded. 
ii. Qualitative interviews: will be undertaken with 20 consumers, 5 GPs and cardiologists and 
2 cardiac telehealth nurses. Interviews will explore barriers and facilitators to delivery of the 
intervention. Interviews will be recorded either via Zoom or a digital audio recorder and later 
deleted following transcription by an external service within 10-15 days. Information 
gathered will be securely stored in a password protected folder on the Baker Heart and 
Diabetes network, with access restricted only to authorised study personnel. 
 
11. 
FOLLOW-UP PROCEDURES 
Patients will be followed up for a total of 12 months, with clinic reviews at 12 months. Clinic reviews in 
Melbourne will occur at the Baker Clinical Trials Research Centre in Wyndham. 
At 30 and 90 days follow-up, data on readmissions will be collected from medical records and at 90 
days, patients will complete a questionnaire to assess the quality of CAD-specific care received via the 
Patient Assessment of Chronic Illness Care (PACIC) 20. 
At 12 months follow-up, a brief clinical assessment, including pathology blood tests noted in 10.2.a.ii 
(estimated 15-45 ml) and some questionnaires (10.2.b) will be repeated. Repeated echocardiogram 
and exercise capacity will also be performed by personnel blinded to the patient’s treatment group. 

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12. 
INTERVENTION GROUP – DISEASE MANAGEMENT PROGRAM 
Intervention patients will receive the Risk-Guided CAD program after hospital discharge in addition to 
standard care. Risk-Guided CAD will follow the evidence-based direction and guidance on Phase 2 CR 
program content, as recently outlined by the Heart Foundation21. Risk-Guided CAD will be led by a 
nurse care co-ordinator who will oversee delivery of a multi-component intervention and remain 
responsible for assessing participant progress. Key features include the following. 
 
12.1 Nurse care planning and health coaching 
Nurses will be appropriately trained to deliver a patient-centred program and to facilitate transition of 
care from hospital to home via: 
a. GP/Specialist liaison - enabled via case conferences (by Zoom video-conference, phone or 
email) to review patient care plans and provide education opportunities to facilitate optimisation 
of therapy. Nurses will escalate any identified risks/gaps in service delivery and contribute to 
development of the care plan incorporating medication up-titration (completion of MBS Item 721 
and 723 will facilitate referrals to other allied health providers or pharmacists as appropriate). 
 
b. Risk factor management and provision of gold standard pharmacologic treatments in order to 
achieve ideal goal levels and ensure application of pharmacologic therapy22 that is advocated to 
achieve maximal cardiac protection. Standard medical therapy will be administered to all patients, 
at the clinician’s discretion22. Default medications for all patients are aspirin (or dual antiplatelet 
therapy if indicated), statin, β blocker and angiotensin converter enzyme inhibitor22. There will be 
no attempt to influence the selection of medications. However, the default position, arranged as 
part of transition care for intervention patients particularly those with LVEF <40%, will be a 
planned up-titration with consideration to other prescribed medications and any advice from the 
GP or cardiologist to the contrary (refer Table 3). Such advice might be provoked by side-effects 
such as hypotension (i.e. systolic BP <100mmHg) or bradycardia (i.e. heart rate <50/min), with 
these criteria pre-specified in a GP letter. Drug intolerance (e.g. to statin) will be addressed by a 
pre-specified drug substitution, preceded by statin withdrawal if necessary for symptoms. The 
GP will be notified in advance and GP appointments (fortnightly) will be made accordingly during 
the up-titration phase. 
 
Table 3. An example of a planned up-titration of cardio-protective therapies in LVEF <40% 
 
Weeks since starting therapy 
 
0 
2 
4 
6 
8 
10 
12 
14 
16 
ACE-inhibitor: 
Ramipril (mg/day) 
 
β blocker: 
 
1.25 
 
2.5 
 
2.5 
 
2.5 
 
2.5 
 
2.5 
 
2.5 
 
5 
 
10 
Carvedilol (mg/day) 
 
Statin: 
0 
0 
6.25 
12.5 
25 
37.5 
50 
50 
50 
Atorvastatin (mg/day) 
80 
80 
80 
80 
80 
80 
80 
80 
80 
 
 
c. Scheduled telehealth follow-up (fortnightly x2, 4 weekly x2, 6 weekly x6) provided by the 
cardiac nurse via Zoom video-conferencing. The objective is to provide health education, 
guidance on lifestyle changes, ensure adequate medication supply and discuss any clinical 
signs and symptoms. GP and other medical appointments will also be reviewed. Behavioural 
counselling will help reinforce self-care and management plans. 
 
 

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Protocol: Version 1.2; 19 May 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3. Schedule of tele-health sessions. 
 
12.2 eHealth strategies 
eHealth strategies will offer greater flexibility whilst enabling continued access to routine health care 
and services. Risk-Guided CAD will integrate healthcare practices into nurse care co-ordination that 
will be supported by the following electronic processes: 
a. SmartCR is a smartphone/tablet compatible app developed by Cardihab which follows Australian 
guidelines to address all components of a Phase 2 CR program23. As shown in Figure 4, this 
health platform monitors health and exercise and delivers motivational and educational materials 
to patients via prompted tasks and links to audio, written articles and video files (including 
education on symptoms and disease management). Physical activity monitoring will be collected 
through self-report and the in-built pedometer. The whole program will be delivered over six 
weeks, according to weekly themes and elements. CR nurses will provide scheduled telehealth 
consultations of ~15 to 30 minutes each (as per Figure 3). The first two weeks after discharge 
will be dedicated to transition of care, medication reconciliation and up-titration, development of 
the care plan and GP communication. The SmartCR program will therefore start in study week 
3 and be completed by week 10. Before commencing the program, all intervention patients will 
receive detailed program information and training on technology use. Technical support will be 
provided by a member of the study team or if necessary, Cardihab. Nurses will access SmartCR 
data and use this to guide behaviour change during telehealth follow-up. 
 
b. SmartCR app data use and storage- 
 
Personal information and data collected in the Cardihab application will be securely stored on 
a cloud based server in Australia.  This information will only be accessible to permitted 
individuals in the research team or clinicians given access by the research team via a clinical 
portal.  Data stored on the app will remain for as long as the patient has the app on their 
phone. Data is synced to Cardihab's cloud storage and will be retained as per Australian 
Privacy Act Cth(1988) and Health Records Act. However, Cardihab has chosen to archive 
and store indefinitely on behalf of the owner Baker Heart and Diabetes Institute.   
 
Week
0
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51
52
Hospital 
admission
Baseline clinic
12-month     
follow-up
Getting started/care 
plan/symptom action 
plan/meds
Risk factors, 
exercise, meds
SmartCR App -    
Phase 2 CR       
(6 weeks with an 
initial and final 
assessment)
Phase 3 CR
EP exercise program
Tele-health session
Supervised exercise program (3x 1 hour/week for 6 weeks)
30 day secondary outcome
90 day primary outcome

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
 
 
Figure 4. Cardihab Phase 2 CR program. 
 
c. Exercise programs will be individually tailored from the baseline fitness assessment for patients 
on an opt-in basis. The supervised program, matched to a 6-week duration, is planned to be 
delivered from ~Week 4 via a combination of in-person visits progressing to unsupervised home 
activity24. The exercise prescription will include 3 x 60 minute sessions per week, including a 
combination of moderate intensity and high-intensity interval exercise training. Whole-body 
resistance circuit training will also be performed in the supervised setting, including 6-8 
movements. After completion of the 6-week supervised phase, participants will be provided with 
a home-based program involving 3 exercise sessions per week for the remaining ~42 weeks. 
Participants will be supervised by an Accredited Exercise Physiologist and sessions will be 
conducted in groups of up to 6. During supervised sessions, rating of perceived exertion, heart 
rate and workload will be documented for all participants to monitor adherence to the exercise 
protocol.  
 
The initial exercise session will include education and familiarisation with the exercise program. 
Specifically the participants will be educated on monitoring and adjusting exercise intensity to 
achieve the desired exercise stimulus. Through educating participants and encouraging a patient 
centred approach to exercise, we aim to promote self-efficacy to encourage exercise 
continuation in the non-supervised phase. Participants will receive continued support from the 
Exercise Physiologist through the supervised phase and via the study nurse following completion 
of the supervised program. 

Title: Risk-Guided CAD 
 
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Protocol: Version 1.2; 19 May 2021 
 
13. 
CONTROL GROUP 
Usual care patients will receive standard cardiology care as scheduled that includes adherence to 
guideline-based care (medications and physical activity), education (self-care), a treatment plan to 
manage co-morbidities, early post-discharge follow-up/support and routine preventative care. 
 
14. 
STUDY TIMELINE 
Study recruitment will occur for 9-12 months (5-7 patients/week) which is feasible from referrals to 
eight HeartWest cardiologists. The intervention and follow-up visits will be completed by the end of 
2022 for study evaluation.  
 
15. 
STUDY POWER 
As derived from our contemporary Australian data, assuming a readmission rate at 90 days in patients 
aged <65 years of 42% and 40% reduction in risk with a DMP intervention, we require 117 patients per 
group. Allowing for attrition of 15%, 135 per group will be required to be randomised. 
 
16. 
STATISTICAL ANALYSES 
All analyses will be performed on an intention-to-treat basis. The primary endpoint (all-cause 
readmission or death at 90 days) will be analysed using a log-binomial regression. Secondary endpoints 
will be assessed by modelling of change in outcome variables (eg. in QoL, exercise capacity and cardiac 
function) adjusted for baseline values. Multiple logistic regression will determine independent correlates 
of readmission. Cox proportional hazards regression will be used to analyse repeated readmissions 
during the follow-up period.  
 
 
 

Title: Risk-Guided CAD 
 
15 
Protocol: Version 1.2; 19 May 2021 
17. 
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