Tailoring Post Discharge - Remote Education and Access for Cardiac Health

NCT07171580 | Not Yet Recruiting

• 1 other identifier: TPD-REACH Protocol
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction (MI)

Keywords

Percutaneous Coronary Intervention; Education; Support; Digital Health Tool; Remote Home Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Composite of Events

  30 days post hospital discharge

• Individual Components of Composite Events

  30 days post hospital discharge

• Individual Components of Composite Unexpected Healthcare Visits

  30 days post hospital discharge

• PAM-13 - Patient Activation Measure

  Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge

• Generalized Anxiety Disorder (GAD) - 7

  Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge

Study Arms (3)

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.

Other: Remote Home Monitoring - Education

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.

Other: Remote Home Monitoring - Education and Support

Interventions

Remote Home Monitoring - Education OTHER

A virtual platform will be used to provide education to ACS patients post discharge.

Education Only (EA)

Remote Home Monitoring - Education and Support OTHER

A virtual platform will be used to provide education and support to ACS patients post discharge.

Full Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old, type 1 myocardial infarction27, resident of Manitoba

You may not qualify if:

• Patients unable to consent or fully participate in the study due to:
• Technology barriers
• Lack of digital device, internet access or data
• Discomfort with using technology
• Communication or language barriers preventing participation
• Cognitive or mental health limiting informed consent or participation
• Dementia or cognitive impairment
• Active or severe psychosis or other significant mental health conditions c. Active substance abuse
• High-risk ACS where patients require more frequent or in person visits a. Cardiac:
• i. Coronary
• Unrevascularizedleftmainormultivessellargeepicardialcoronary artery disease (\>2.5mm)
• Coronary artery bypass surgery (CABG) during index hospitalization ii. Arrhythmias
• Cardiac arrest during index event/hospitalization (ventricular tachycardia (VT)/ventricular fibrillation (VF), pulseless electrical activity (PEA)) iii. Cardiomyopathy
• Left ventricular ejection fraction (LVEF) \<35% (most recent EF assessment)
• Cardiogenic shock requiring pressors/inotropes for more than 24 hours

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (1)

St Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Shuangbo Liu, MD

CONTACT

204-258-1266; sliu@sbgh.mb.ca

Andrea de Haan, BA (Hons)

CONTACT

204-258-1001; adehaan@sbgh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Model Details: Comparing 3 interventional groups: 1) Standard Care 2) Education Only 3) Full Intervention (Education and Support)

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CA (1)