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

NCT03745547 | Completed

• 1 other identifier: SP/C/007
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate Chronic Obstructive Pulmonary Disease; Severe Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant adherence

  weekly email surveys and phone calls over a nine month period

Interventions

Adherence to wearing a Spire wearable health monitor OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spire, Inc.: lead
• ResMed: collaborator

Study Sites (1)

Spire, Inc.

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neema Moraveji, PhD

  Spire, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: November 20, 2018
• Primary Completion: April 10, 2020
• Study Completion: April 11, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)