- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443982
Acute Myocardial Infarction - Allied Health-Oriented Patient-centered Digitally-Enabled Care (AMI-HOPE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The AMI-HOPE program addresses three critical healthcare challenges: insufficient specialist capacity, limited outpatient clinic infrastructure, and excessive dependence on hospital-based rather than community-based care during the vulnerable early post-discharge period for myocardial infarction patients. The program trains pharmacists to provide comprehensive post-MI (Myocardial Infarction) care through personalized cardiovascular medication optimization, targeted interventions for patients with reduced ejection fraction, smoking cessation support, and lifestyle counseling covering diet and exercise. Care delivery occurs remotely through integrated digital health platforms that facilitate continuous vital signs monitoring, deliver structured patient education at strategic intervals, and promote effective self-management capabilities.
This proof-of-value stepped-wedge pragmatic trial that evaluates the effectiveness of the AMI-HOPE intervention is conducted across seven hospitals and eighteen primary care polyclinics spanning Singapore's three health clusters.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Singapore, Singapore
- National Heart Centre Singapore (NHCS)
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Singapore, Singapore
- Changi General Hospital (CGH)
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Singapore, Singapore
- Khoo Teck Puat Hospital (KTPH)
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Singapore, Singapore
- National University Heart Centre, Singapore (NUHCS)
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Singapore, Singapore
- Ng Teng Fong General Hospital (NTFGH)
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Singapore, Singapore
- Tan Tock Seng Hospital (TTSH)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or Female, aged 21 to 90 years (inclusive), at the time of signing the informed consent form
- Clinically diagnosed with AMI during index hospitalisation
- Own a mobile phone with internet access- intervention arm only
Exclusion Criteria:
- Patients who are planned for palliative care or life expectancy <1 year
- Foreigners who do not have Singaporean citizenship/ Permanent Resident (PR) status
- Patients who are enrolled into Healthier SG affiliated with General Practitioners (GPs)
- Allergy or intolerance of Angiotensin-Converting Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARB)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Standard of Care
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Standard of care treatment without the pharmacist-led digital platform assisted care
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Other: Pharmacist-led digital platform assisted care
AMI-HOPE centers around a digital platform that offers continuous telemonitoring on patients' vitals, tailored medication prescription with support from pharmacists, and personalised lifestyle nudges and educational material.
|
Up titration of medications by pharmacist.
AMI-HOPE centers around a digital platform that offers continuous telemonitoring on patients' vitals, tailored medication prescription with support from pharmacists and personalised lifestyle nudges and educational material.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Death and Unplanned Cardiovascular Disease (CVD) related (non-fatal MI, non-fatal stroke, others) rehospitalizations
Time Frame: between enrolment and end of 12-month follow up
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Counts and time to any events of death or unplanned CVD related rehospitalizations
|
between enrolment and end of 12-month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute change in concentration of Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: between enrolment and end of 12-month follow up
|
Absolute change in LDL-C (in mmol/L) from enrollment to end of 12 month follow up period
|
between enrolment and end of 12-month follow up
|
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Change in Blood Pressure (BP)
Time Frame: At discharge, 2 week, 1, 3, 6, 9 &12 months
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Absolute change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (in mmHg) from enrollment to end of 12 month follow up period
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At discharge, 2 week, 1, 3, 6, 9 &12 months
|
|
Change in Haemoglobin A1c (HbA1c)
Time Frame: between enrolment and end of 12-month follow up
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Absolute change in HbA1c (in %) from enrollment to end of 12 month follow up period
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between enrolment and end of 12-month follow up
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|
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants
Time Frame: At 1 month and 12 month
|
EQ-5D was calculated to evaluate quality of life (QoL) in participants.
EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
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At 1 month and 12 month
|
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Patient Activation Measure (PAM-13) Scores in Participants
Time Frame: At discharge and 6month
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The Patient Activation Measure 13 (PAM-13) is a non-disease-specific survey that assesses a patient's knowledge, skills, and confidence for self-management.
It uses 13 items on a 4-point Likert scale, with the raw sum score (ranging from 13-52) being transformed into a standardized 0-100 metric.
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At discharge and 6month
|
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Seattle Angina Questionnaire-7 (SAQ-7) Scores in Participants
Time Frame: At 1 month and 12 month
|
The change from baseline in Health-Related Quality of Life (HRQOL) is assessed by the SAQ-7.
The SAQ-7 is a validated tool assessing three domains: physical limitation, angina frequency, and quality of life.
An overall summary score is calculated by averaging the three domain scores (0-100), where higher scores indicate better health status (i.e., less frequent angina, better function, and higher quality of life).
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At 1 month and 12 month
|
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Patient Health Questionnaire-9 (PHQ-9) Scores in Participants
Time Frame: At 1month and 12 month
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The PHQ-9 is a validated 9-item self-report instrument used for screening and assessing the severity of depression.
Each item is scored from 0 ("not at all") to 3 ("nearly every day") based on symptom frequency over the past two weeks, yielding a total score from 0 to 27, with higher scores indicating greater depression severity.
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At 1month and 12 month
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Presence of angina pectoris as determined by the Rose Angina Questionnaire
Time Frame: At 1month and 12month
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The Rose Angina Questionnaire is a standardized, validated set of questions used to identify the presence of angina pectoris in epidemiological studies.
It consists of a structured interview algorithm that classifies participants based on their responses to questions about chest pain characteristics, leading to a categorical outcome (e.g., definite angina, possible angina, or no angina).
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At 1month and 12month
|
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Dose of ACE/ARB/MRA inhibitor
Time Frame: At discharge, 1, 3, 6 &12 months
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Change in drug intensity score for ACE inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (ACE I/ARB/ARNI) and beta blockers, to assess the effect of the pharmacist led intervention on prescription, early up titration, and adherence to drugs, and the subsequent impact on LDL C, blood pressure, HbA1c control, and left ventricular ejection fraction (LVEF).
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At discharge, 1, 3, 6 &12 months
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Percentage of patients smoking
Time Frame: At 1,3, 6 & 12 month
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Each patient would be asked to indicate whether they are currently an active smoker(yes/no) at each point of assessment (at 1,3, 6 & 12 month).
The change in percentage of active smoker in the duration of the programme is use to assess the effectiveness of the smoking cessation programme.
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At 1,3, 6 & 12 month
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Length of stay
Time Frame: Baseline
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To assess the clinical efficiency of the intervention
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cost-effectiveness
Time Frame: At the end of 12-month follow up
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Health benefits expressed in Quality-Adjusted Life Years (QALYs) and incremental cost-effectiveness ratio (ICER) as the incremental cost of intervention delivery divided by the incremental health outcome (QALYs gained), to assess cost-effectiveness
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At the end of 12-month follow up
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Collaborators and Investigators
Investigators
- Principal Investigator: Mark Chan, National University Heart Centre, Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRGTC-0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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