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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04966117




Registration number
NCT04966117
Ethics application status
Date submitted
29/06/2021
Date registered
19/07/2021

Titles & IDs
Public title
Risk-guided Disease Management in Coronary Artery Disease
Scientific title
A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
Secondary ID [1] 0 0
266/21
Universal Trial Number (UTN)
Trial acronym
Risk-CAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Chronic Disease 0 0
Nurse's Role 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Risk-Guided DMP
BEHAVIORAL - Usual Care

Experimental: Risk-Guided DMP - The intervention is a 12 month disease management program after hospital discharge for coronary artery disease that is overseen by a cardiac nurse.

Active comparator: Usual Care - Usual care patients will receive standard cardiology care.


BEHAVIORAL: Risk-Guided DMP
Patients will be assigned a cardiac nurse to help manage their heart condition who will:

1. develop a care plan and communicate with the patients' General Practitioner (GP) and cardiologist about management, particularly medications to help control risk factors.
2. provide health coaching at pre-specified times over 12 months via telehealth (phone or video call) to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes.
3. facilitate cardiac rehabilitation via a smart phone or tablet app (called SmartCR). This app monitors health and physical activity, has prompted tasks to do and delivers education via video, audio and written articles. The information from this app can be used by the cardiac nurse during telehealth follow-up.
4. invite participation to a supervised 6-week group exercise program which will require using our on-site gym.

BEHAVIORAL: Usual Care
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospitalization or death
Timepoint [1] 0 0
90 days post discharge
Secondary outcome [1] 0 0
Hospitalization or death
Timepoint [1] 0 0
30 days post discharge
Secondary outcome [2] 0 0
Provider adherence to best practice guidelines
Timepoint [2] 0 0
12 months post discharge
Secondary outcome [3] 0 0
Risk factor control - lipids
Timepoint [3] 0 0
12 months post discharge
Secondary outcome [4] 0 0
Risk factor control - blood pressure
Timepoint [4] 0 0
12 months post discharge
Secondary outcome [5] 0 0
Health well-being
Timepoint [5] 0 0
12 months post discharge

Eligibility
Key inclusion criteria
1. Aged between 30 to 74 years; AND
2. Hospitalised with CAD or other eligible cardiac procedure or condition including acute myocardial infarction (STEMI or NSTEMI), unstable angina, coronary artery bypass grafting or percutaneous coronary intervention; AND
3. Defined as higher risk (score >= 5) by PEGASUS-TIMI 54 criteria; AND
4. Eligible for Medicare.
Minimum age
30 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to provide written informed consent; OR
2. Non-English speaking; OR
3. Inability to attend clinic visits; OR
4. Inability to engage with an app due to low technical literacy or lacking access to a smart phone or wi-fi; OR
5. Hospitalised with a primary diagnosis of heart failure; OR
6. eGFR <30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR
7. Valve disease only; OR
8. Requiring palliative care; OR
9. Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR
10. Participating in another study with a potential but unknown effect on outcome.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Heartwest
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Queen's University, Belfast
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Western Health
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Melinda J Carrington, PhD
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melinda J Carrington, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8532 1638
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data to be shared will be all of the individual participant data collected during the trial, after de-identification and underlying published results only. The data will be available to only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator. The data will be available for any approved purpose.

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
Immediately following publication; no end date.
Available to whom?
Access subject to approvals by Principal Investigator.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://baker.edu.au/research/laboratories/preclinical-disease-prevention


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04966117