Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients
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ClinicalTrials.gov Identifier: NCT05518981 |
Recruitment Status :
Completed
First Posted : August 29, 2022
Last Update Posted : August 29, 2022
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Tracking Information | |||||||
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First Submitted Date | August 25, 2022 | ||||||
First Posted Date | August 29, 2022 | ||||||
Last Update Posted Date | August 29, 2022 | ||||||
Actual Study Start Date | May 1, 2019 | ||||||
Actual Primary Completion Date | February 28, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
All-Cause Hospitalizations [ Time Frame: 1 year pre- and 1 year post-initiation of RPM (2 years total) ] The change in number of all-cause hospitalizations per patient
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients | ||||||
Official Title | The Clinical Significance of Patient Care Escalations From a Remote Monitoring Service | ||||||
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). | ||||||
Detailed Description | This study included a retrospective analysis of data collected from subjects at a large outpatient pulmonology practice in the mid-Atlantic region of the United States between May 2019 and February 2022. At this clinic, patients who were candidates for RPM had been offered voluntary participation in service tailored to chronic respiratory disease patients (Spire Health, San Francisco, CA, USA). They continued regular follow-ups with their pulmonologists and received usual care according to the direction of their primary pulmonary physician for their COPD. Inclusion criteria for the present study included a clinical diagnosis of COPD (COPD, chronic bronchitis, obstructive lung/airways disease, or emphysema), subscribed to RPM for at least 12 months as of February 28, 2022, full electronic medical records (EMR) at the site in question for one year before and one year after the start of RPM, and high healthcare utilization (≥1 ER visit or hospitalization in the year prior to enrollment). All such patients were included in the analysis. The primary endpoint was unplanned, all-cause hospitalizations per subject. Secondary endpoints included unplanned cardiopulmonary hospitalizations, respective lengths of stay, ER visits, outpatient pulmonary visits, and systemic corticosteroid use, adherence to RPM, and time-to-visit (RPM escalation to provider visit). |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
Condition | Chronic Obstructive Pulmonary Disease | ||||||
Intervention | 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.
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Study Groups/Cohorts | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
126 | ||||||
Original Actual Enrollment | Same as current | ||||||
Actual Study Completion Date | February 28, 2022 | ||||||
Actual Primary Completion Date | February 28, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT05518981 | ||||||
Other Study ID Numbers | 20210406 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Spire, Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Spire, Inc. | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators |
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Investigators |
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PRS Account | Spire, Inc. | ||||||
Verification Date | August 2022 |