Standard of Care (SOC)
OtherStandard of care treatment without the pharmacist-led digital platform assisted care
NCT Number: NCT07443982
The Acute Myocardial Infarction - allied Health Oriented, Patient centered, and digitally Enabled care (AMI-HOPE) program is a model of care designed to improve post-AMI well-being, safety, and outcomes through greater involvement of AHPs in patient care and integrating digital technologies into routine primary care disease management. AMI-HOPE aims to deliver solutions to these identified gaps of care which will transform healthcare planning both at cluster and national levels. The cornerstone of the AMI-HOPE program will be upskilling pharmacists to take on low-intermediate complexity clinician roles during the post-discharge period. The first 6 months will be anchored by tertiary care before a handoff to primary care. This frees up cardiologists to focus on high complexity cases.
This study is active but is not currently recruiting participants.
21 year–90 year
All sexes
Interventional
Not applicable
Changi General Hospital (CGH), Singapore
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care treatment without the pharmacist-led digital platform assisted care
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.
Time frame: between enrolment and end of 12-month follow up
Counts and time to any events of death or unplanned CVD related rehospitalizations
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
Time frame: At discharge, 2 week, 1, 3, 6, 9 &12 months
Absolute change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (in mmHg) from enrollment to end of 12 month follow up period
Time frame: between enrolment and end of 12-month follow up
Absolute change in HbA1c (in %) from enrollment to end of 12 month follow up period
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.
Time frame: At discharge and 6month
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.
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).
Time frame: At 1month and 12 month
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.
Time frame: At 1month and 12month
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).
Time frame: At discharge, 1, 3, 6 &12 months
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).
Time frame: At 1,3, 6 & 12 month
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.
Time frame: Baseline
To assess the clinical efficiency of the intervention
Time frame: At the end of 12-month follow up
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
National University Heart Centre, Singapore
Other
Acronym: AMI-HOPE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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