An Exploratory, Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in COPD Subjects

An Exploratory,Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in Study Subjects With COPD

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.

Study Overview

• Status: Completed
• Conditions: Severe Chronic Obstructive Pulmonary Disease; Moderate Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Adherence to wearing a Spire wearable health monitor

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.

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Spire, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spire wearable health monitor physiological data collection	To evaluate the extent to which Spire wearable health monitor can capture viable data from COPD participants	weekly email surveys and phone calls over a nine month period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant adherence	To evaluate the daily adherence to wearing the Spire wearable health monitor in COPD participants	weekly email surveys and phone calls over a nine month period

Collaborators and Investigators

• Sponsor: Spire, Inc.
• Collaborators: ResMed
• Investigators: Principal Investigator: Neema Moraveji, PhD, Spire, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): April 11, 2020

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SP/C/007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No