Chronic Obstructive Pulmonary DiseaseNCT05518981
Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by Spire, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Respiratory Remote Patient Monitor (Spire Health Tag)
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Significance of Patient Care Escalations From a Remote Monitoring Service
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).
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Respiratory Remote Patient Monitor (Spire Health Tag)
- Keywords
- Acute Exacerbation of COPD, Hospitalization, Exacerbation, Remote Patient Monitoring, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Hospitalizations
The change in number of all-cause hospitalizations per patient
Measured: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary outcomes (8)
Cardiopulmonary Hospitalizations
The change in number of cardiopulmonary hospitalizations per patient
Measured: 1 year pre- and 1 year post-initiation of RPM (2 years total)
All-Cause Emergency Room (ER) Visits
The change in number of all-cause ER visits per patient
Measured: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Cardiopulmonary Emergency Room (ER) Visits
The change in number of cardiopulmonary ER visits per patient
Measured: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Pulmonary Outpatient Visits
The change in number of pulmonary outpatient visits per patient
Measured: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Length of Stay
Length of hospitalization
Measured: 1 year pre- and 1 year post-initiation of RPM (up to 2 years total)
Systemic Corticosteroid Use
Number of new prescriptions of corticosteroids given by pulmonologist
Measured: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Adherence to RPM
Proportion of days during the intervention period where physiological sensors were worn for at least 8 hours
Measured: 1 year
Time to Visit
Time from escalation to visit with provider
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 May 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spire, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pulmonary Associates of Richmond, The University of Texas Health Science Center at San Antonio
- Responsible party
- Sponsor
- Investigators
- Neema Moraveji, PhD, Principal investigator, Spire Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518981
- Sponsor's protocol ID
- 20210406
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Patient Care Escalations From a Remote Monitoring Service
- ClinicalTrials.gov ID
- NCT05518981
- Acronym / sponsor ID
- 20210406
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acute Exacerbation of COPD, Hospitalization, Exacerbation, Remote Patient Monitoring, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Spire, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pulmonary Associates of Richmond, The University of Texas Health Science Center at San Antonio
- Study start
- 1 May 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
8 secondary outcomes
Cardiopulmonary Hospitalizations
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
All-Cause Emergency Room (ER) Visits
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Cardiopulmonary Emergency Room (ER) Visits
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Pulmonary Outpatient Visits
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Length of Stay
Time frame: 1 year pre- and 1 year post-initiation of RPM (up to 2 years total)
Systemic Corticosteroid Use
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Adherence to RPM
Time frame: 1 year
Time to Visit
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neema Moraveji, PhD principal investigator
Spire Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Spire, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Hospitalizations (time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.