Patient-Reported Outcome Measures for Coronary Artery Disease

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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment ePROM Survey for coronary artery disease?

The research highlights the importance of patient-reported outcome measures (PROMs) in assessing health-related quality of life for coronary artery disease patients, suggesting that these measures can provide valuable insights into the benefits of treatments beyond traditional clinical outcomes like morbidity and mortality. ^{1 2 3 4 5}

Is the ePROM Survey safe for humans?

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 quality of life in heart disease patients, which suggests it is a non-invasive and generally safe method for collecting information. ^{1 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Stephen B Wilton, MD, MSc

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. China pubmed.ncbi.nlm.nih.gov

[Establishment and primary screening of primitive entry pool of rating scale for patient-reported outcomes of coronary heart disease angina]. [2016]

2. Australia pubmed.ncbi.nlm.nih.gov

Psychometric properties of health related quality of life measures in acute coronary syndrome patients: a systematic review protocol. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Using patient-reported outcome measures for primary percutaneous coronary intervention. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Review of available instruments and methods for assessing quality of life in anti-anginal trials. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of a Canadian version of the Seattle Angina Questionnaire (SAQ-CAN). [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Tablet Computer System to Collect Patient-reported Symptom Severity in Patients Undergoing Diagnostic Coronary Angiography. [2016]