Recruiting

ePROM System

Sponsor:

University of Calgary

Code:

NCT06164457

Conditions

Coronary Artery Disease

Patient Acceptance of Health Care

Physician-Patient Relations

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

ePROM Survey

Study Details

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.

Conditions

Coronary Artery Disease

Patient Acceptance of Health Care

Physician-Patient Relations

Study ID

NCT06164457

Start date

Jun 8, 2024

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control Group

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

experimental: Intervention Group

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

Interventions

ePROM Survey

The APPROACH ePROM survey consists of several well validated PROM instruments, including the Seattle Angina Questionnaire 7-item version,\[4\] the EuroQol EQ5D-5L,\[5\] the Medical Outcomes Study Social Support Scale (8 item version),\[6\] the Patient Health Questionnaire 2-item and 9-item (PHQ2/9) depression screening tools\[7\], and the Self-Care of Coronary Heart Disease Inventory (SC-CHDI-V3).\[8\]

Primary outcome measure

  • ePROM usage metrics [ Time Frame: Usage metrics will be collected during the intervention period (~4 months) ]
  • Acceptability of the Clinician Report to clinicians [ Time Frame: Post-visit surveys will be completed following every patient visit during the intervention period (~4 months), the exit interview will occur at the end of the intervention period. ]
  • Acceptability and utility of the ePROM Patient Survey and Clinician Report to patients [ Time Frame: Patients will complete a post-visit survey following each visit during both the control and intervention period (~8 months). ]

Central Contacts and Locations

Central contacts

Stephen B WIlton, MD, MSc

4032207102sbwilton@ucalgary.ca

Maria E Dalton, MSc.

4032106215maria.dalton1@ucalgary.ca

Locations

Cumming School of Medicine, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N1N4

Contacts

Stephen B Wilton, MD, MSc.

4032107102sbwilton@ucalgary.ca

Maria E Dalton, MSc

4032106215maria.dalton1@ucalgary.ca

Department of Medicine, University of Alberta

Recruiting

Calgary, Alberta, Canada, T6G2R3

Contacts

Michelle Graham, MD

mmg2@ualberta.ca

Maria Dalton, MSc

4032106215maria.dalton1@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • coronary artery disease
  • patient reported outcome measures
  • cardiac science
  • communication assessment
  • quality improvement
  • feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-14.