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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Age less than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 days post hospital discharge
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to understand how best to help cardiac patients transition from hospital to home, with appropriate educational & community supports for improved outcomes.
Who is the study for?
This trial is for adults who had a heart attack or acute coronary syndrome, are low risk based on cardiac risk and other health conditions, and have internet access. They must live in Winnipeg and be able to consent. High-risk patients, those under 18, or without web access can't join.
What is being tested?
The study tests two post-hospital discharge methods for heart attack patients: a virtual remote home monitoring platform versus rapid response nursing support for up to 30 days. It aims to determine the best way to educate and support these patients at home.
What are the potential side effects?
Since this trial involves educational and supportive interventions rather than medications, traditional side effects are not expected. However, there may be stress or discomfort associated with adapting to new technology or schedules.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 days post hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 days post hospital discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Congestive Heart Failure - Composite outcome measure
Mortality - Composite outcome measure
Re-Admission - Composite outcome measure
+1 moreSecondary study objectives
EQ-5D-5L - Health related Quality of Life
EQ-VAS - Health related Quality of Life
General Anxiety Disorder (GAD) - 7
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Remote Home Monitoring (RHM)Experimental Treatment1 Intervention
Remote Home Monitoring Platform (RHM): will be utilized to help tailor education and support for the patient after they have been discharged from the hospital. The platform will provide access to and delivery of health related education and information for continued self-care within the community. The platform will be used to evaluate post discharge symptoms and for health care providers to access the need for continued direct patient care and education through virtual processes.
Group II: Rapid Response Nursing (RRN)Active Control1 Intervention
Rapid Response Nursing Team (RRN): The RRN will help clients/patients to:
* Understand their current health conditions, treatments, how to manage symptoms and when/who to ask for help; Specifically; they will
* Help clients to understand their hospital discharge plan;
* Support patients during their recovery at home;
* Reinforce and contribute to in-hospital education about heath health and recovering safely at home;
* Review medications to help clients understand the purpose, side effects and how to take prescribed medications correctly, including assisting clients with getting prescriptions filled;
* Connect with their Home Clinic, ensuring everyone has the necessary information for follow-up care;
* Connect clients with a Home Clinic if they do not have one; and
* Access appropriate home supports to help clients remain at home safely for as long as possible.
Group III: RegistryActive Control1 Intervention
Registry Arm:
Patients who fit the criteria for study inclusion and choose not to participate in the main study will be provided with an opportunity to consent to the registry arm of the study. The registry arm of the study is an opportunity to establish a standard of care group free from research bias. Patients who enroll in the registry will only need to complete a short questionnaire before they are discharged home which will take approximately 5 minutes. Additionally, research staff will also complete a medical chart review to identify specific medical information related to their demographics, cardiac procedure, hospital stay, recovery, and to identify any re-admissions to hospital that may have occurred after the patient has been discharged home.
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Who is running the clinical trial?
St. Boniface HospitalLead Sponsor
54 Previous Clinical Trials
14,834 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered low risk for heart problems and have support.I am under 18 years old.I was treated for acute coronary syndrome at St. Boniface Hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Remote Home Monitoring (RHM)
- Group 2: Rapid Response Nursing (RRN)
- Group 3: Registry
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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