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Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients

NCT05518981 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2022-08-29

No results posted yet for this study

Summary

This pre/post study was a retrospective analysis of unplanned hospitalization rates in a cohort of COPD subjects started on remote physiologic monitoring (RPM) at a large, outpatient pulmonary practice. The study included all subjects with high healthcare utilization (≥1 hospitalization or emergency room visit in the prior year) who had elected to enroll in an RPM service for assistance with clinical management. Additional inclusion criteria included being on RPM for at least 12 months and a patient of the practice for at least two years (12 months pre- and post-initiation of RPM).

Conditions

Interventions

DEVICE

Respiratory Remote Patient Monitor (Spire Health Tag)

The RPM service, tailored to chronic respiratory disease patients, utilizes a system that includes three components: undergarment-adhered cardiorespiratory sensors, in-home data transmission hub, and web-based clinical dashboard. The sensors are a set of six proprietary, skin-safe devices that include sensors for intermittent photoplethysmography, continuous respiratory force, and tri-axis accelerometers for activity. Clinical liaisons monitor deviations from patient-specific baselines and contact subjects for a "risk assessment" call, including questions about symptoms. If a subject fails the risk assessment, they are escalated to the site to be seen, and potentially treated, by their pulmonologist.

Sponsors & Collaborators

  • Pulmonary Associates of Richmond

    collaborator UNKNOWN

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • Spire, Inc.

    lead INDUSTRY

Principal Investigators

  • Neema Moraveji, PhD · Spire Health

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-02-28
Completion
2022-02-28
FDA Device
Yes

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 NCT05518981 on ClinicalTrials.gov