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Establishing Clinical Utility for a New Diagnostic Test for Patients With Shortness of Breath

NCT04693793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2023-12-07

No results posted yet for this study

Summary

This study will collect high-quality data on how practicing specialist physicians, specifically cardiologists and pulmonologists, across the U.S. currently manage patients with unexplained chronic dyspnea and and how the results of Janssen Pharmaceuticals' test change clinical decision making. To do so, this study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions.

Conditions

  • Dyspnea
  • Unexplained Chronic Dyspnea

Interventions

OTHER

Education Materials and Janssen Test

Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the Janssen technology. These materials are comprised of a slide deck, a sample test report, and a frequently asked questions (FAQ) sheet. Intervention 1 participants only will receive the Janssen test results whether they select it or not, and Intervention 2 participants will receive the Janssen test results only if they select it during the second round of case simulations.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Qure Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • John W Peabody, MD PhD · President, QURE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2022-09-15
Completion
2022-10-15

Countries

  • United States

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 NCT04693793 on ClinicalTrials.gov