MedTrace Logo

Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease

NCT06164457 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

OTHER

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).\[8\]

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephen B Wilton, MD, MSc · APPROACH Research Group, Libin Cardiovascular Institute, Cumming School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-08
Primary Completion
2027-01-31
Completion
2027-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164457 on ClinicalTrials.gov