| CTRI Number |
CTRI/2024/09/073989 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Helping Patients Manage Cholesterol After a Heart Attack: A Research Study in Asia-Pacific |
|
Scientific Title of Study
|
Guideline Oriented Approach to Lipid Lowering In Asia-Pacific (GOAL-ASIA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ragini Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Biochemistry, All India Institute of Medical Sciences, Parapipaliya, Rajkot, Gujarat
Rajkot GUJARAT 360006 India |
| Phone |
9624000839 |
| Fax |
|
| Email |
singh.ragini28@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ragini Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Biochemistry, All India Institute of Medical Sciences, Parapipaliya, Rajkot, Gujarat
Rajkot GUJARAT 360006 India |
| Phone |
9624000839 |
| Fax |
|
| Email |
singh.ragini28@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Ragini Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Biochemistry, All India Institute of Medical Sciences, Parapipaliya, Rajkot, Gujarat
Rajkot GUJARAT 360006 India |
| Phone |
9624000839 |
| Fax |
|
| Email |
singh.ragini28@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Monash University, Australia |
|
|
Primary Sponsor
|
| Name |
Monash University |
| Address |
Wellington Road, Clayton VIC 3800, Melbourne, Australia |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia China Malaysia Republic of Korea Singapore Taiwan Thailand India Japan |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ragini Singh |
All India Institute of Medical Sciences (AIIMS), Rajkot, Gujarat |
Central Biochemistry Laboratory, Ground floor, IPD complex, All India Institute of Medical Sciences (AIIMS), Para Pipaliya, Rajkot, , Gujarat Rajkot GUJARAT |
9624000839
singh.ragini28@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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.
The total duration of the intervention using the cholesterol score card in the GOAL-ASIA study is 12 months. It consists of two stages: Stage I (0-6 months) and Stage II (6-12 months). Participants randomized to the early intervention group receive the multifaceted intervention during Stage I, while the late group receives standard care during this period and the intervention during Stage II. |
| Comparator Agent |
Patients receiving standard of care" with no intervention i.e. cholesterol score card |
Standard of Care: Patients in this arm receive the usual clinical care for lipid management. This includes:
Routine follow-up and monitoring of lipid profiles.
Lipid results are shared with the patients primary care physician or clinician, but there is no additional intervention beyond standard lipid management practices.
This arm serves as the control for the first 6 months in the trial for comparison with the early intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients hospitalised with Type I Myocardial Infarction aged equal to or more than 18
years of age. |
|
| ExclusionCriteria |
| Details |
LDL Cholesterol more than 1.4 mmol per litre at baseline.
unable to provide contact details of a nominated clinician.
Unable to provide written informed consent.
Unlikely to survive greater than 12 months. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of patients achieving LDL-Cholesterol less than 1.4 mmol/l at six months |
The primary outcome will be measured at 6 months from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
the proportion of patients who undergo intensification of lipid-lowering therapy at 6 months.
The proportion of patients prescribed a guideline- recommended high-intensity statin at any time during the first 6 months.
The proportion of patients prescribed a guideline- recommended high-intensity statin at 6 months.increase the proportion of patients reporting high levels of adherence to their lipid lowering therapy at 6 months
The level of patient activation & engagement in their care. |
Intensification of Lipid-Lowering Therapy:
At 6 months.
Prescription of Guideline-Recommended High-Intensity Statin:
At any time during the first 6 months & at 6 months.
High Adherence to Lipid-Lowering Therapy:
At 6 months.
Patient Activation & Engagement (PAM-13):
At baseline & 6 months. |
|
|
Target Sample Size
|
Total Sample Size="1928" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
 Almost half of the global burden of cardiovascular disease arises from the Asia Pacific (Li, 2020). While many high income Asia-Pacific nations have enjoyed reductions in overall mortality through improved control of hypertension and implementation of smoking cessation programs, CVD and its atherosclerotic manifestations of heart attack, stroke and subsequent heart failure, remain the dominant cause of regional disability adjusted life years (DALYs)(Li, 2020). This burden of disease impacts not only patients, households and their families but also the public economy which sustains direct and indirect costs of rising acute and chronic care costs and the broader losses of early retirement and consequent reductions in domestic productivity. Once established, the risk of sustaining a further ASCVD complication such as a myocardial infarction, stroke, limb loss or cardiovascular death is at least 10% per year with overall mortality being 6-fold that of those without established disease (Morrow, 2010). 1.2. Gaps in care Despite these alarming statistics, control of modifiable risk factors remains suboptimal globally. In the most recent data from Europe and the US, less than 1/3 of patients with established atherosclerotic disease achieve a lipid target of <1.4mmol/L with barely 50% prescribed a guideline-recommended high intensity statin (Ray, 2021). These important gaps in statin use and residual cholesterol levels represent significant forfeiture of opportunity to modify risk for both patients and populations. Accordingly there is considerable interest in understanding barriers to guideline adoption and developing interventions to address this underuse. While statin intolerance renders achievement of LDL-C goals challenging for up to 15% of patients, studies evaluating clinician rationale for not intensifying therapy reveal a combination of knowledge gaps and clinical inertia in as many as 50% of cases (Langer, 2020). 1.3. Multifaceted intervention Studies evaluating predominantly provider-focused approaches (e.g. academic detailing, audit and feedback) or predominantly patient-focused approaches (e.g. motivational interviewing, direct outreach) have shown statin use can be increased by about 5-10% (30-50% relative increase) with each intervention. However, less is known about their use in other populations outside of the US and Europe and while several of these intensive, high-touch interventions have shown efficacy, there is a need to evaluate flexible, low-touch alternatives which can be scaled across regions and populations and are nested in pragmatic, real-world care environments. 1.4. The GOAL intervention Recently, a predominantly patient-focused intervention aimed at improving the use of guideline-directed medical therapy for heart failure increased the number of medication intensifications by 60% within a 12-month period compared to standard of care (Allen, 2021). This intervention involved the patient being counselled about the rationale for the medications and using this engagement in a flipped-classroom manner to drive adoption of guideline-based therapies with their treating clinician. GOAL will use a similar approach by providing patients with the knowledge and tools to generate a conversation about achieving their lipid-lowering goals using the ‘Cholesterol Score Card’.
A large body of evidence has shown that the most effective interventions aimed at improving care quality are multifaceted and involve both patient and physician components. In addition to the Score Card, the second component of the GOAL intervention will be the provision of a risk-based assessment to the patient’s nominated clinician (general practitioner, hospitalist, cardiologist) for ongoing care post discharge. This will involve the provision of a multivariable risk calculator percentage likelihood of a recurrent event in addition to a patient’s potential additional ‘genetic’ risk conveyed by their Lp(a) value. In the primary prevention setting, presentation of the risk-based information increases their acceptance and adherence to preventive therapies (Bengtsson, 2021; Naslund, 2019). It is hypothesised the provision of similar information in the GOAL intervention will encourage the clinician to intensify lipid lowering therapy and increase the likelihood of achieving LDL-C targets. |