Status:
COMPLETED
Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)
Lead Sponsor:
Menzies Institute for Medical Research
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Diagnostic Services Pty Ltd
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
The IDEAL study is a randomized controlled trial among people referred to pathology services to have blood cholesterol measured. Study participants will have cardiovascular risk factors (e.g. age, sex...
Detailed Description
The IDEAL study aims to improve the way doctors identify and manage patients at risk of cardiovascular disease, including conditions such as heart attack or stroke. This research focuses on an improve...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2024
Estimated Enrollment :
2761 Patients enrolled
Trial Details
Trial ID
NCT04896021
Start Date
May 26 2021
End Date
September 23 2024
Last Update
May 9 2025
Active Locations (1)
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1
Menzies Institute for Medical Research
Hobart, Tasmania, Australia, 7000