MedTrace Logo

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

NCT03745547 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2021-01-15

No results posted yet for this study

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

Interventions

OTHER

Adherence to wearing a Spire wearable health monitor

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.

Sponsors & Collaborators

  • ResMed

    collaborator INDUSTRY

  • Spire, Inc.

    lead INDUSTRY

Principal Investigators

  • Neema Moraveji, PhD · Spire, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-04-10
Completion
2020-04-11

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745547 on ClinicalTrials.gov