NCT06164457 Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease
| NCT ID | NCT06164457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-08 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-06-08 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Investigators recently developed the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools to collect individual results from online quality of life and health status surveys for patients with coronary heart disease, and report them back to their treating clinicians. This pilot interventional study uses a pre-post design to assess whether implementing the ePROM system into routine care is feasible and acceptable to patients and physicians, and to inform feasibility for a larger clinical trial. Specifically, the investigators aim to evaluate use of the ePROM Patient Survey and Clinician Report among eligible outpatients with known or suspected coronary artery disease and their cardiologists. Additionally, the investigators aim to determine if the use of the APPROACH ePROMs Clinician Report in routine medical encounters is acceptable (based on administrative burden, ease of use, and time required) to patients and clinicians, and supports effective communication for management of symptoms of coronary artery disease.
Eligibility Criteria
Patient Inclusion Criteria: * age at least 40 years. * either (i) known coronary artery disease (defined as a history of myocardial infarction, percutaneous or surgical coronary revascularization, or documentation of obstructive coronary artery disease on previous invasive or CT angiography) or (ii) suspected coronary artery disease (defined as stable angina or anginal equivalent symptoms) as the reason for referral to a cardiologist. * Able to communicate in English or be willing to have an English-speaking family member or friend assist with survey completion. * Access to the internet, valid email address, and a web-enabled device, for survey completion. * Upcoming outpatient visit with a study cardiologist in the next 14-28 day Exclusion criteria: \- N/A, all inclusion criteria must be met to participate Physician Inclusion Criteria: We will recruit 4 cardiologists to participate, 2 each from Alberta Health Services Edmonton and Calgary zones, including both academic and community practice settings. To be eligible, cardiologists will need to have an active outpatient practice including moderate to high volumes of patients being assessed and managed for coronary artery disease, and to be willing to commit to participating in all aspects of the study
Contact & Investigator
Stephen B Wilton, MD, MSc
PRINCIPAL INVESTIGATOR
APPROACH Research Group, Libin Cardiovascular Institute, Cumming School of Medicine
Frequently Asked Questions
Who can join the NCT06164457 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06164457 currently recruiting?
Yes, NCT06164457 is actively recruiting participants. Contact the research team at sbwilton@ucalgary.ca for enrollment information.
Where is the NCT06164457 trial being conducted?
This trial is being conducted at Calgary, Canada, Calgary, Canada.
Who is sponsoring the NCT06164457 clinical trial?
NCT06164457 is sponsored by University of Calgary. The principal investigator is Stephen B Wilton, MD, MSc at APPROACH Research Group, Libin Cardiovascular Institute, Cumming School of Medicine. The trial plans to enroll 200 participants.