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

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ClinicalTrials.gov Identifier: NCT03745547
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Spire, Inc.

Tracking Information
First Submitted Date November 14, 2018
First Posted Date November 19, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date November 20, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2018)
Spire wearable health monitor physiological data collection [ Time Frame: weekly email surveys and phone calls over a nine month period ]
To evaluate the extent to which Spire wearable health monitor can capture viable data from COPD participants
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03745547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 14, 2018)
Participant adherence [ Time Frame: weekly email surveys and phone calls over a nine month period ]
To evaluate the daily adherence to wearing the Spire wearable health monitor in COPD participants
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Moderate Chronic Obstructive Pulmonary Disease
  • Severe Chronic Obstructive Pulmonary Disease
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 5, 2019)
200
Original Estimated Enrollment
 (submitted: November 14, 2018)
150
Estimated Study Completion Date May 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Neema Moraveji, PhD 833-658-5700 study@spire.io
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03745547
Other Study ID Numbers SP/C/007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No IPD will be available to other researchers
Responsible Party Spire, Inc.
Study Sponsor Spire, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Neema Moraveji, PhD Spire, Inc.
PRS Account Spire, Inc.
Verification Date April 2019