ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03745547
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Spire, Inc.

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.


Condition or disease Intervention/treatment
Moderate Chronic Obstructive Pulmonary Disease Severe Chronic Obstructive Pulmonary Disease 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 that results in hospitalization, 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
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory,Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in Study Subjects With COPD
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Intervention Details:
  • 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 3 days the participant's emergency contact will be contacted. If neither the participant nor the emergency contact is reachable over 10 days the participant will be removed from the study.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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 Android 6.0 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 smartphone connected to Wi-Fi throughout the study duration)

Exclusion Criteria:

  • Patients rated 3 or 4 on ECOG scale.
  • Diagnosed with another medical condition that may confound the respiratory symptoms of COPD (ex: cystic fibrosis, lung cancer, bronchiectasis, congestive heart failure, pulmonary hypertension, idiopathic pulmonary fibrosis, or chest wall deformities).
  • Diagnosed with any neurodegenerative disorder (e,g, Parkinson's, Alzheimer's or Epilepsy)
  • Diagnosed with any terminal illness or having a life expectancy of less than the study duration.
  • Pregnant at the time of study or expecting to become pregnant throughout the course of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745547


Contacts
Contact: Neema Moraveji, PhD 833-658-5700 study@spire.io

Locations
United States, California
Spire, Inc. Recruiting
San Francisco, California, United States, 94110
Contact: Neema Morajevi, PhD    833-658-5700      
Sponsors and Collaborators
Spire, Inc.
Investigators
Principal Investigator: Neema Morajevi, PhD Spire, Inc.

Responsible Party: Spire, Inc.
ClinicalTrials.gov Identifier: NCT03745547     History of Changes
Other Study ID Numbers: SP/C/007
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be available to other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases