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Heart attacks are one of the top causes of death in Canada, with over 2,100 cases treated each year in Manitoba. Even though hospital care has improved, the period after going home is still risky. Many patients feel anxious and unsure about their recovery, and without enough support, they often end up back in the emergency department (ED). This is an even bigger challenge for people in rural areas, where getting follow-up care can be much harder. Filling these gaps is important to help patients get better and to reduce stress on the healthcare system.
In a previous study, the investigators found that extra support made a big difference: only 8% of participants using a digital health tool returned to the ED within 30 days, compared to 22% of participants without it. Now, the investigators want to expand this study across Manitoba to see if digital health tools can help more people recover safely at home. The investigators will compare two types of follow-up care: education only versus education with extra support (like symptom tracking and virtual appointments). The investigators will look at how this affects hospital visits, mental well-being, and healthcare costs. The goal is to create a better support system for people after a heart attack, leading to healthier recoveries, less strain on hospitals, and better care for Manitobans - no matter where they live.
STUDY AIM To evaluate the feasibility and effectiveness of a digital-based short-term post-discharge care program - providing education alone or with additional support - in reducing 30-day unexpected healthcare visits after discharge in low-to-intermediate risk ACS patients in Manitoba, compared to standard care.
STUDY OBJECTIVES Primary Objective: to compare the incidence of 30-day unexpected healthcare visits among low-intermediate risk ACS patients in Manitoba who receive education and support or education alone via a DHT, versus those receiving standard care.
Secondary Objectives: will examine 3 spheres of outcomes, across the 3 study groups:
STUDY DESIGN This study is a single-center, pragmatic randomized controlled trial designed to evaluate post discharge support for low-intermediate risk ACS patients. Before hospital discharge, patients will be screened for eligibility. At discharge, eligible patients will be randomly assigned to one of three groups: (1) standard care; (2) education only and (3) education and support. The pragmatic design ensures that all study procedures-including recruitment, intervention, and follow-up-are closely integrated with routine clinical care, with minimal deviations beyond the study intervention itself. This approach enhances real-world applicability, making it easier to implement findings into everyday clinical practice. Study design and implementation are guided by the PRagmatic Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to ensure clinical relevance and feasibility. Full Research Ethics Board and institutional review board approval will be obtained before the study begins. The study will be registered on ClinicalTrials.gov.
STUDY INTERVENTION Remote Home Monitoring (RHM) is a secure, web-based, digital health application designed to support patients in their recovery. When used to its fullest extent, patients can access tailored education, real-time monitoring, track their health, and connect with care providers. RHM aims to improve patient knowledge, encourage self-management, and provide timely clinical support to reduce unexpected healthcare visits.
Study participants will be randomly assigned to one of three groups: standard care arm (SA), RHM education only arm (EA), RHM full intervention arm with education and support (FA). Before discharge, all patients will be provided with a blood pressure monitor and oximeter, allowing them to track their blood pressure and blood oxygen saturation at home. This not only supports ongoing health monitoring but also empowers patients to take an active role in managing their health.
(A) Standard Care Arm: Patients will receive standard education in hospital. They will not be registered in the RHM application or receive education modules, health care interviews or virtual appointments.
(B) Education Only Arm: Patients will be enrolled in the RHM application, allowing tracking of their access to the education modules. They will start with an introductory module, followed by one module per day for a total of 7 modules covering key topics related to ACS (Cardiac Rehabilitation, Heart Attack Risk Factors, Living with Heart Disease, Medications, Mental Health, Nutrition, Physical Activity). Participants that have atrial fibrillation will receive an additional education module on that topic, and participants with heart failure with receive an additional education module relating to that topic. Engagement for modules will be monitored, if any patient misses more than one module, they will be contacted for a reminder and troubleshooting. Participants will have access to the RHM education modules for 30 days post hospital discharge.
(C) Full Intervention Arm: Patients will be enrolled in the RHM application. Patients will receive all interventions in the EA, and in addition, they will receive support through the RHM application. Patients will complete health care surveys three times a week, covering topics such as symptoms, vital signs, medication side effects, functional status, and whether they have questions or concerns. Patients will have three scheduled virtual appointments with a cardiologist on 1 day, 1 week, 2 weeks after discharge. If a patient misses a survey, they will be prompted. Patients will also have access to unscheduled health care interviews, virtual appointments, and a hotline for additional questions or concerns. Participants will have access to the RHM education modules and program support for 30 days post hospital discharge.
Participants will be asked to complete questionnaires at three time points: baseline (link to access the questionnaires via REDCap will be sent on the day of hospital discharge), 14 days post discharge, and 30 days post discharge. These include validated tools to assess psychosocial well-being (GAD-7, PHQ-9, EQ-5D-5L, EQ-VAS) and patient activation (PAM-13). They will also complete surveys that cover demographics, health literacy, care transition, unexpected healthcare visits, and satisfaction with care. Responses will be securely collected and stored using REDCap, ensuring both convenience for participants and data integrity for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care (SA) | No Intervention | Patients will receive standard education in hospital. They will not be registered in the RHM application or receive education modules, health care interviews or virtual appointments. | |
| Education Only (EA) | Experimental | Patients will be enrolled in the RHM application, allowing tracking of their access to the education modules. They will start with an introductory module, followed by one module per day for a total of 7 modules covering key topics related to ACS (Cardiac Rehabilitation, Heart Attack Risk Factors, Living with Heart Disease, Medications, Mental Health, Nutrition, Physical Activity). Participants that have atrial fibrillation will receive an additional education module on that topic, and participants with heart failure with receive an additional education module relating to that topic. Engagement for modules will be monitored, if any patient misses more than one module, they will be contacted for a reminder and troubleshooting. Participants will have access to the RHM education modules for 30 days post hospital discharge. |
|
| Full Intervention | Experimental | Patients will be enrolled in the RHM application. Patients will receive all interventions in the EA, and in addition, they will receive support through the RHM application. Patients will complete health care surveys three times a week, covering topics such as symptoms, vital signs, medication side effects, functional status, and whether they have questions or concerns. Patients will have three scheduled virtual appointments with a cardiologist on 1 day, 1 week, 2 weeks after discharge. If a patient misses a survey, they will be prompted. Patients will also have access to unscheduled health care interviews, virtual appointments, and a hotline for additional questions or concerns. Participants will have access to the RHM education modules and program support for 30 days post hospital discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Home Monitoring - Education | Other | A virtual platform will be used to provide education to ACS patients post discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Unexpected Healthcare Visits | 30-day unexpected healthcare visits (including emergency department, urgent care, walk in clinic or nursing station) | 30 days post hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Events | Composite of death, MI, repeat revascularization, readmission, stroke, vascular complication, new HF or needing admission | 30 days post hospital discharge |
| Individual Components of Composite Events |
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Inclusion Criteria:
>18 years old, type 1 myocardial infarction27, resident of Manitoba
Exclusion Criteria:
Patients unable to consent or fully participate in the study due to:
Technology barriers
Communication or language barriers preventing participation
Cognitive or mental health limiting informed consent or participation
High-risk ACS where patients require more frequent or in person visits a. Cardiac:
i. Coronary
Non-atherosclerotic causes of ACS (spontaneous coronary artery dissection, stress- induced cardiomyopathy, myocarditis) as the education and treatment is different
Any additional factor preventing full participation in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuangbo Liu, MD | Contact | 204-258-1266 | sliu@sbgh.mb.ca | |
| Andrea de Haan, BA (Hons) | Contact | 204-258-1001 | adehaan@sbgh.mb.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Comparing 3 interventional groups: 1) Standard Care 2) Education Only 3) Full Intervention (Education and Support)
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|
| Remote Home Monitoring - Education and Support | Other | A virtual platform will be used to provide education and support to ACS patients post discharge. |
|
Individual components of death, MI, repeat revascularization, readmission, stroke, vascular complication, new HF or needing admission
| 30 days post hospital discharge |
| Individual Components of Composite Unexpected Healthcare Visits | Individual components of unexpected healthcare visits including emergency department, urgent care, walk in clinic or nursing station | 30 days post hospital discharge |
| PAM-13 - Patient Activation Measure | This survey will measure patient knowledge, skills, and confidence in self- managing their health | Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge |
| Generalized Anxiety Disorder (GAD) - 7 | GAD-7 this survey measures self-report anxiety symptoms with a total score from 0-21. Lower scores indicate fewer anxiety symptoms | Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge |
| Patient Health Questionnaire (PHQ) - 9 | PHQ-9 this survey measures self-report depression symptoms with a total score from 0-27. Lower scores indicate fewer depressive symptoms | Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge |
| EQ-5D-5L - Health Related Quality of Life | EQ-5D-5L - This survey will measure 5 aspects of self-reported quality of life for patients. Each component is scored from 1-5 with a total score of the tool from 5-25. Lower scores indicate better outcomes | Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge |
| EQ-VAS - Health Related Quality of Life | EQ-VAS - this survey measures self-report quality of life on a scale of 0-100. Higher scores indicate better self reported quality of life | Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge |
| Patient Satisfaction Questionnaire | Patient Satisfaction with the care received and the study program | At 30 days post hospital discharge |
| Overall Healthcare Cost Savings per Patient | Average difference in healthcare costs between the study arms based on healthcare utilization. | 30 days post hospital discharge |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |