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Guideline Oriented Approach To Lipid Lowering In Asia-Pacific
Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.
Study details:
The study will be conducted over two phases. In phase I (0-6 months), participants randomized to 'early' will receive the intervention at baseline through 6 months, while those randomized to 'late' will receive standard-of-care and represent a control arm over this period. In phase II (6 to 12 months), those randomized to 'late' will receive the intervention at 6 months, while the 'early' group will continue in follow-up.
Multifaceted Intervention The intervention aims to increase the likelihood of effecting guideline-directed change in lipid lowering therapy through two key actors - both the patient and their clinician(s). The intervention is deliberately nested within routine clinical care to enhance the generalisability of the findings beyond a research environment and to reflect other elements of real world practice. * Patient-and-clinician 'Cholesterol score card'.
This passport-sized document will serve as a communication, engagement and activation tool for patients. It will be provided to participants at the commencement of the intervention and filled out at each study follow up visit. Participants will be encouraged to fill out sections at clinically-driven follow up appointments with their treating clinicians (e.
g. general practitioner, cardiologist). The Score Card documents four key fields to be completed by the participant, study team and participant's regular clinician including 1) 'current' LDL-C level, 2) participant's level of adherence to lipid-lowering therapy using modified Voil's criteria, 3) lipid-lowering management decisions made at the clinician's appointment and 4) currently prescribed lipid-lowering therapies.
* Risk stratification for recurrent events. As part of the intervention, each participant will have their SMART Risk score of a recurrent event assessed using the 'U-prevent' online calculator. In addition, each participant's Lp(a) will be measured and presented graphically on a continuum of risk.
Both of these risk assessments will be sent to the treating primary care clinician and a copy provided to the participant. Standard of care Participants allocated to 'late' will receive standard-of-care for the first 6 months which involves the provision of the participant's lipid profile to their nominated primary care physician/general practitioner at 6 weeks, 3 months and 6 months.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-09-15
Primary completion: 2024-12-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT05325034
Intervention or treatment
BEHAVIORAL: Early Intervention
Conditions
- • Cardiovascular Diseases
- • Acute Coronary Syndrome
- • Atherosclerosis
- • Hypercholesterolemia
Find a site
Closest Location:
Flinders Medical Centre
Research sites nearby
Select from list below to view details:
Flinders Medical Centre
Bedford Park, South Australia, Australia
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, Australia
Cairns & Hinterland Hospital & Health Service
Cairns, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Early intervention
| BEHAVIORAL: Early Intervention
|
OTHER: Late intervention
| BEHAVIORAL: Early Intervention
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Proportion of patients achieving an LDL <1.4mmol/L | Proportion of patients achieving an LDL \<1.4mmol/L at 6 months. This will be determined from values obtained through local laboratory testing. | 6 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Proportion of patients who undergo intensification of lipid-lowering therapy | Proportion of patients who undergo intensification of lipid-lowering therapy in 6 months | 6 months |
| Proportion of patients prescribed high-intensity statin | Proportion of patients prescribed a guideline-recommended high-intensity statin through 6 months | 6 months |
| Proportion of patients prescribed high-intensity statin at 6 months | Proportion of patients prescribed a guideline-recommended high-intensity statin at 6 months | 6 months |
| Adherence to lipid lowering therapy | Proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months | 6 months |
| Patient activation and engagement in care | Level of patient activation and engagement in their care at 6 months compared with baseline | 6 months |
| Proportion of patients achieving LDL<1.4mmol/L at 12 months | Proportion of patients achieving LDL\<1.4mmol/L at 12 months | 12 months |
Frequently Asked Questions
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