Clinical trial NCT03745547: An Exploratory, Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in COPD Subjects
Official title: An Exploratory,Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in Study Subjects With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate Chronic Obstructive Pulmonary Disease
Severe Chronic Obstructive Pulmonary Disease
Lead sponsor: Spire, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ResMed
First posted: 2018-11-19
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult moderate Chronic Obstructive Pulmonary Disease (COPD) and severe Chronic Obstructive Pulmonary Disease (COPD) as reported by participant

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Self-reported diagnosis of moderate to severe COPD
* \>=1 self-reported COPD-related hospitalization within the previous 12 months
* Currently using an iPhone 6 or newer and willing to install the Spire smartphone app
* Willing to wear Health Tags 80% of each 24 hour period and answer the email-based self-assessments weekly for the study duration
* Willing to provide consent to participate and abide by study protocol for study duration (9 months)
* Must be able to read and understand English
* Access to Wi-Fi at home and at work, for at least 20 hours per day (and smartphone connected to Wi-Fi throughout the study duration)

Exclusion Criteria:

* Diagnosed with another medical condition that may confound the respiratory symptoms of COPD (ex: cystic fibrosis, lung cancer, bronchiectasis, idiopathic pulmonary fibrosis, or chest wall deformities).
* Diagnosed with any neurodegenerative disorder (e,g, Parkinson's, Alzheimer's or Epilepsy)
* Pregnant at the time of study or expecting to become pregnant throughout the course of the study.

Primary outcomes:
measure: Spire wearable health monitor physiological data collection
timeFrame: weekly email surveys and phone calls over a nine month period
Secondary outcomes:
measure: Participant adherence
timeFrame: weekly email surveys and phone calls over a nine month period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Spire, Inc.
state: California
Study officials:
affiliation: Spire, Inc.
name: Neema Moraveji, PhD
role: PRINCIPAL_INVESTIGATOR
References: