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
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- 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.
- 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
- 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
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
|Contact: Neema Moraveji, PhDemail@example.com|
|United States, California|
|San Francisco, California, United States, 94110|
|Contact: Neema Morajevi, PhD 833-658-5700|
|Principal Investigator:||Neema Morajevi, PhD||Spire, Inc.|