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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04896021




Registration number
NCT04896021
Ethics application status
Date submitted
11/05/2021
Date registered
21/05/2021

Titles & IDs
Public title
Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)
Scientific title
Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)
Secondary ID [1] 0 0
GNT1170815
Secondary ID [2] 0 0
HREC23015
Universal Trial Number (UTN)
Trial acronym
IDEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Cardiovascular disease risk assessment
Diagnosis / Prognosis - Usual care assessment

Experimental: Intervention - On referral to Tasmanian pathology services for blood cholesterol, intervention participants will have their blood pressure measured and collated with other cardiovascular disease risk factors. An absolute cardiovascular disease risk score is calculated, interpreted according to guideline recommendations and reported to referring doctors via the established pathology system. High risk is highlighted in red as per usual practice for pathology tests outside of normal range, and advice provided regarding appropriate action according to National Vascular Disease Prevention Alliance guidelines.

Active comparator: Control - On referral to Tasmanian pathology services for blood cholesterol, control participants will have their blood pressure measured and collated with other cardiovascular disease risk factors as per the intervention arm. However, only the results relating to blood cholesterol are reported to the referring doctor, as per usual practice.


Diagnosis / Prognosis: Cardiovascular disease risk assessment
Intervention in which the addition of guideline-recommended absolute cardiovascular disease risk assessment is embedded into point-of-care blood collection services for cholesterol measurement and results (including risk score) are reported to referring doctors.

Diagnosis / Prognosis: Usual care assessment
Usual care in which blood cholesterol results are reported to referring doctors
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Antihypertensive and/or statin medications dispensed
Timepoint [1] 0 0
1 year after randomization
Secondary outcome [1] 0 0
Cost effectiveness
Timepoint [1] 0 0
1 year after randomization
Secondary outcome [2] 0 0
Barriers and enablers
Timepoint [2] 0 0
1 year after randomization

Eligibility
Key inclusion criteria
* Patients referred to pathology services for blood cholesterol (lipids; total cholesterol and HDL cholesterol) who are eligible for absolute CVD risk assessment according to the National Vascular Disease Prevention Alliance guidelines (this includes all adults aged 45 years and over without a known history of CVD, or Aboriginal and Torres Strait Islander people aged 35 years or over) and willing to provide permission to access to PBS-linked data on medications prescribed and dispensed.
* Adults already deemed to be at increased risk that do not require absolute CVD risk assessment according to guidelines will also be included because there is evidence that these people are undertreated (Heeley EL, et al Med J Aust 2010;192:254-9; Peiris DP, et al Med J Aust 2009;191:304-9) and therefore may benefit from improved assessment. This includes adults with any of the following: Diabetes and age >60 years; Diabetes with microalbuminuria (>20 mcg/min or urinary albumin:creatinine ratio >2.5 mg/mmol for males, >3.5 mg/mmol for females); Moderate or severe CKD (persistent proteinuria or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2); A previous diagnosis of familial hypercholesterolaemia; Serum total cholesterol >7.5 mmol/L; Aboriginal and Torres Strait Islander adults aged over 74
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Adults already taking antihypertensive or lipid lowering medications (determined by self-report at baseline)
* if the referring doctor is not from a general practice included in the study cluster list,
* if participants cannot provide an email address to be used to provide a copy of their signed consent form.
* If at least one measurement of blood pressure is unable to be obtained at baseline assessment.
* For safety reasons, people will be excluded if they are found at the time of assessment at the pathology services with an average systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg.

Study design
Purpose of the study
Treatment
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 receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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
26/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
9714
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Menzies Institute for Medical Research - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies Institute for Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Diagnostic Services Pty Ltd
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Department of Health Tasmania
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Primary Health Tasmania
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
National Heart Foundation, Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Healthcare Software Pty Ltd
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Uscom Limited
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
James E Sharman, PhD
Address 0 0
Menzies Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 deidentified study data, including data dictionaries, will be made publicly available on reasonable request via the University of Tasmania's Research Data Portal (consistent with the Australian Code for the Responsible Conduct of Research).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
12 months after publication of the principal findings
Available to whom?
Access subject to approvals by the Principal Investigator consistent with the Australian Code for the Responsible Conduct of Research.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04896021