Remote Home Monitoring for Heart Attack

(TPD-REACH Trial)

Overseen By Andrea de Haan, BA (Hons)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Disqualifiers: Dementia, Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether digital health tools can help people recover safely at home after a heart attack. Researchers compare two follow-up care methods: one with education alone and another with education plus additional support, such as symptom tracking and virtual appointments. They aim to determine if these tools reduce hospital visits, improve mental well-being, and lower healthcare costs. This trial may suit Manitobans who have had a heart attack and are comfortable using technology for their healthcare. As an unphased study, it offers an opportunity to contribute to innovative healthcare solutions that could enhance recovery experiences for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that remote home monitoring is safe for heart attack patients?

Research has shown that using digital tools at home is generally safe for people recovering from heart attacks. These tools assist patients in managing their recovery without serious issues. Most individuals handle this well, helping them avoid extra hospital visits.

Adding features like symptom tracking and virtual doctor appointments also proves safe. Studies have found no major safety concerns with these tools. They help patients feel more connected and supported during recovery. Overall, these digital health tools have a good safety record for heart attack recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Home Monitoring (RHM) approach for heart attack patients because it offers a unique blend of convenience and comprehensive care. Unlike the current standard of care, which typically involves hospital-based education and follow-up, RHM allows patients to receive continuous support and education from the comfort of their homes. The RHM system uses a mobile application to deliver daily educational modules, track symptoms, and facilitate virtual appointments with cardiologists, ensuring personalized and timely healthcare. This method not only empowers patients with knowledge about their condition but also provides easy access to medical support, potentially improving recovery outcomes and reducing hospital readmissions.

What evidence suggests that this trial's treatments could be effective for heart attack recovery?

Studies have shown that digital healthcare tools can significantly aid recovery after a heart attack. This trial will divide participants into groups to evaluate the effectiveness of remote home monitoring. In previous research, only 8% of patients using a digital health tool returned to the emergency room within 30 days, compared to 22% who did not use it. One group in this trial will receive education solely through the Remote Home Monitoring (RHM) application, which assists in adhering to recovery plans and enhances mental health. Another group will receive both education and additional support, such as symptom tracking and virtual doctor visits, making this approach even more effective. This comprehensive support helps patients feel safer at home, potentially reducing hospital visits and improving overall well-being. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals in Manitoba who have recently had a heart attack. It aims to help those especially in rural areas, where follow-up care can be challenging. Participants should be adults who've been discharged after a heart attack and are now at home.

Inclusion Criteria

Residents of Manitoba

I am over 18 and have had a type 1 heart attack.

Exclusion Criteria

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, Active substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Before hospital discharge

Treatment

Participants receive either standard care, education only, or full intervention with education and support via a digital health platform

30 days

3 virtual appointments (1 day, 1 week, 2 weeks post-discharge)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including unexpected healthcare visits and patient-reported outcomes

30 days

Questionnaires at baseline, 14 days, and 30 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Remote Home Monitoring - Education
• Remote Home Monitoring - Education and Support

Trial Overview The study tests two types of post-discharge care: one group receives educational materials only, while the other gets both education and additional support like symptom tracking and virtual check-ins. The goal is to see which method better prevents return trips to the hospital.

How Is the Trial Designed?

Group I: Full Intervention Experimental Treatment 1 Intervention

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.

Group II: Education Only (EA) Experimental Treatment 1 Intervention

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.

Group III: Standard Care (SA) Active Control 1 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.

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials

55

Recruited

15,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11733394/

Effectiveness of 'Internet Plus' remote management in ... The “Internet Plus” remote management significantly enhances exercise tolerance, cardiac rehabilitation compliance, and mental health

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589750025000123

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.125.012034

National Patterns of Remote Patient Monitoring Service ... We observed a significant increase in the proportion of hospitalizations occurring at hospitals offering RPM services for both HF (OR of being ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287401/

Effectiveness of digital healthcare to improve clinical ... Digital healthcare demonstrates superior post-discharge optimization of CAD outcomes, significantly attenuating mortality and morbidity. Subject ...

5. tenovi.com tenovi.com/remote-patient-monitoring-heart-disease/

Remote Patient Monitoring in Heart Disease In this article, you'll discover the effectiveness of cardiac remote patient monitoring in managing heart disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12029004/

Cardiac Telerehabilitation After Heart Attack Using E ... This narrative review aims to evaluate the current evidence supporting the use of CTR for managing post-myocardial infarction patients, focusing ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation This cloud-based interactive digital self-management application supports remote CR by allowing clinicians to monitor patients' activity and the patient-entered ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...

9. academic.oup.com academic.oup.com/ehjdh/article/6/3/508/8051875

Feasibility, safety and patient perceptions of exercise-based ... We aimed to evaluate feasibility, safety, and patient perceptions of remotely delivered EBCR in a multicentre clinical practice setting after myocardial ...

10. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(25)00012-3/fulltext

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.