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Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)

NCT04896021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2761

Last updated 2025-05-09

No results posted yet for this study

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, blood pressure, diabetes, smoking status) measured within an assessment station at pathology services. A report on cardiovascular risk, in addition to blood cholesterol results, will be sent to the referring doctor along with recommended treatment strategies among those participants randomized to intervention. For control participants, the usual care process will be provided in which only blood cholesterol results will be sent to the referring doctor. The new intervention is expected to lead to better identification and treatment of people at high risk for cardiovascular disease events.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Usual care assessment

Usual care in which blood cholesterol results are reported to referring doctors

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Diagnostic Services Pty Ltd

    collaborator UNKNOWN

  • Department of Health, Tasmania

    collaborator OTHER_GOV

  • Primary Health Tasmania

    collaborator UNKNOWN

  • National Heart Foundation, Australia

    collaborator OTHER

  • Healthcare Software Pty Ltd

    collaborator UNKNOWN

  • Uscom Limited

    collaborator UNKNOWN

  • Menzies Institute for Medical Research

    lead OTHER

Principal Investigators

  • James E Sharman, PhD · Menzies Institute for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2024-09-23
Completion
2024-09-23

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896021 on ClinicalTrials.gov