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

NCT05518981 | Completed FDA Device

• 1 other identifier: 20210406
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

Acute Exacerbation of COPD; Hospitalization; Exacerbation; Remote Patient Monitoring; COPD

Outcome Measures

Primary Outcomes (1)

• All-Cause Hospitalizations

  The change in number of all-cause hospitalizations per patient

  1 year pre- and 1 year post-initiation of RPM (2 years total)

Secondary Outcomes (8)

• Cardiopulmonary Hospitalizations

  1 year pre- and 1 year post-initiation of RPM (2 years total)

• All-Cause Emergency Room (ER) Visits

  1 year pre- and 1 year post-initiation of RPM (2 years total)

• Cardiopulmonary Emergency Room (ER) Visits

  1 year pre- and 1 year post-initiation of RPM (2 years total)

• Pulmonary Outpatient Visits

  1 year pre- and 1 year post-initiation of RPM (2 years total)

• Length of Stay

  1 year pre- and 1 year post-initiation of RPM (up to 2 years total)

Interventions

Respiratory Remote Patient Monitor (Spire Health Tag) DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients at a large outpatient pulmonology practice in the mid-Atlantic region of the United States. They were all candidates for RPM and were offered a voluntary participation in a service tailored to chronic respiratory disease patients.

You may qualify if:

• Clinical diagnosis of COPD (COPD, chronic bronchitis, obstructive lung/airways disease, or emphysema)
• ≥1 hospitalization or emergency visit in the year prior to enrollment
• enrolled in the Spire RPM patient monitoring service for at least 12 months
• a patient of the practice for at least two years (12 months pre- and 12 months post-initiation of RPM).

You may not qualify if:

• None

Sponsors & Collaborators

• Spire, Inc.: lead
• Pulmonary Associates of Richmond: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Spire, Inc.

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neema Moraveji, PhD

  Spire Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: May 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (1)