Patient-Reported Outcome Measures for Coronary Artery Disease

Not yet recruiting at 1 trial location

Overseen By Maria E Dalton, MSc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: None

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electronic survey tool designed to enhance communication between doctors and patients about managing coronary artery disease, a condition where the heart's blood vessels narrow or become blocked. The trial compares two groups: one uses the new survey before their doctor visit, while the other continues with regular care. The goal is to determine if this survey facilitates discussions about symptoms and treatment plans. Individuals diagnosed with or suspecting coronary artery disease, who are seeing a cardiologist soon and have internet access to complete the survey, are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative tools that could improve patient-doctor communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on using a survey tool to improve communication with your doctor, so it's unlikely that medication changes are required.

What prior data suggests that the ePROM Survey is safe for patients with coronary artery disease?

Research has shown that the ePROM Survey helps manage coronary artery disease by collecting patient feedback about their health. Although specific safety data for the ePROM Survey is not available, it is a survey tool, not a medication or treatment, and is generally considered safe. The survey gathers patient-reported health and symptoms, aiding doctors in understanding and managing the disease.

As a non-invasive tool, the ePROM Survey carries no known risks or side effects. Its primary goal is to enhance communication between patients and doctors, potentially leading to better care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces the ePROM survey as a way for patients with coronary artery disease to share their experiences and symptoms before their medical appointments. Unlike traditional treatments that focus only on physical interventions, this approach could enhance patient care by providing doctors with valuable insights directly from the patients themselves. This method aims to improve communication between patients and healthcare providers, potentially leading to more personalized and effective treatment plans.

What evidence suggests that the ePROM Survey is effective for coronary artery disease?

Research has shown that digital healthcare tools like the ePROM Survey can improve the management of coronary artery disease (CAD). In this trial, participants in the intervention group will complete the ePROM patient survey before their care visit, enabling them to share symptoms and feelings directly with their doctors. This process helps doctors understand the patient's condition more clearly and adjust treatment accordingly. Studies have found that using these digital tools can lead to better health outcomes by reducing the risk of death and illness in CAD patients. By enhancing communication between patients and doctors, the ePROM Survey aims to improve the overall care experience. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephen B Wilton, MD, MSc

Principal Investigator

APPROACH Research Group, Libin Cardiovascular Institute, Cumming School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 40 with known or suspected coronary artery disease, who can communicate in English (or have help) and have internet access. They must be seeing a participating cardiologist soon.

Inclusion Criteria

I can communicate in English or have someone who can help me with it.

I have or might have heart artery disease based on my symptoms or past tests.

I am 40 years old or older.

Exclusion Criteria

N/A, all inclusion criteria must be met to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Control Period

Eligible patients are enrolled to establish baseline levels for study measures without receiving the ePROMs intervention.

4 months or until 30 patients are enrolled

1 visit (in-person)

Intervention Period

Patients complete the ePROM survey before their cardiologist appointment, and clinicians receive training on the ePROM Clinician Report.

4 months or until 30 patients are enrolled

1 visit (in-person)

Follow-up

Participants are monitored for the acceptability and utility of the ePROM Patient Survey and Clinician Report.

8 months

What Are the Treatments Tested in This Trial?

Interventions

• ePROM Survey

Trial Overview The study tests an electronic system where patients report their health status online, which then gets shared with their doctors to improve care for heart conditions.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients in this group will complete the ePROM patient survey in advance of their care visit.

Group II: Control Group Active Control 1 Intervention

Patients in this group will attend their cardiology appointment as normal. No intervention present.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11358368/

APPROACH e-PROM system: a user-centered development ... A user-centered development and evaluation of an electronic patient-reported outcomes measurement system for management of coronary artery disease.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25001076

Individualized Electronic Patient-Reported Outcome ... The primary objective of this study is to evaluate the feasibility, acceptability, and efficacy of the APPROACH ePROM clinician report as an adjunct to the care ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06164457

Implementing Individualized Patient Reported Outcome ... Investigators recently developed the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools to collect individual results ...

4. withpower.com withpower.com/trial/patient-reported-outcome-measures-for-coronary-artery-disease-ad018

Patient-Reported Outcome Measures for Coronary Artery ... The research articles do not provide specific safety data for the ePROM Survey, but they focus on using patient-reported outcome measures to assess symptoms and ...

5. 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 ...

6. researchgate.net researchgate.net/publication/383495732_APPROACH_e-PROM_system_a_user-centered_development_and_evaluation_of_an_electronic_patient-reported_outcomes_measurement_system_for_management_of_coronary_artery_disease

(PDF) APPROACH e-PROM system: a user-centered ... This study assesses the validity and reliability of the SAQ in a Canadian cohort of individuals with stable angina. Methods and results Data are ...

7. ijpds.org ijpds.org/article/view/716

Patient-Reported Outcomes Improves the Prediction of In- ... We investigate if the patient reported outcome measures (PROMs) improve the accuracy of readmissions risk prediction models in CAD.