An observational study in Moderate Chronic Obstructive Pulmonary Disease and Severe Chronic Obstructive Pulmonary Disease, sponsored by Spire, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by Spire, Inc. · Observational
The purpose of this study is to monitor adherence to a clothing-attached breathing monitor, respiratory patterns, and activity levels in COPD patients, and correlate those respiratory patterns and activity levels with patient-reported symptoms and events. To achieve this purpose, Spire will collect data from a wearable monitor that participants attach to the participant's clothing, an associated smartphone application, and completion of weekly questions. The wearable monitor and the consumer smartphone application to be used are consumer products and currently available in the market.
This study does not include clinical intervention and no doctors will be involved in this study.
No clinical tests or office visits are included in this study. All data will be collected through an online survey tool and remotely through the wearable sensors.
This is an exploratory, observational, non interventional, single-arm, open label, remote pilot study involving up to 150 self-reported COPD participants. Eligible participants will wear the Spire biophysiological health monitors for a period of 9 months while the participants report symptoms on a weekly basis via brief surveys. If and when participants incur a COPD-related exacerbation which results in a medication change after hospitalization or contact with a healthcare provider, participants will report this on the weekly surveys. When this survey is read by a study nurse, the nurse will follow up with the participant by phone to conduct a post-exacerbation phone screening. This data would provide context to inform how to correlate the biosensor-sensed physiological parameters with the exacerbation self-reported data. All study participants will be remotely distributed throughout the United States.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 184 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →Spire, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult moderate Chronic Obstructive Pulmonary Disease (COPD) and severe Chronic Obstructive Pulmonary Disease (COPD) as reported by participant
Exclusion Criteria:
Participants will wear a Spire health monitor every day for 9 months and receive weekly emails with a short survey about the participant's condition and symptoms. If participants fail to respond to this email or Spire detects that a participant is not wearing the monitor, participants will be contacted by a nurse. While participants are wearing the monitor, Spire will make sure the sensors are collecting data but will not review the data in real time. If a participant's monitor stops sending data to Spire for more than 24 hours, the participant will be contacted. If the participant is unreachable for 10 days the participant's emergency contact will be contacted. If neither the participant nor the emergency contact is reachable over 24 days the participant will be removed from the study.
Spire wearable health monitor physiological data collection
To evaluate the extent to which Spire wearable health monitor can capture viable data from COPD participants
Time frame: weekly email surveys and phone calls over a nine month period
Participant adherence
To evaluate the daily adherence to wearing the Spire wearable health monitor in COPD participants
Time frame: weekly email surveys and phone calls over a nine month period
Plan to share: No — No IPD will be available to other researchers
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Spire, Inc.