An Exploratory, Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in COPD Subjects
Completed
Conditions studied: Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease
In brief
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.
Key facts
- Study ID
- NCT03745547
- Run by
- Spire, Inc.
- People needed
- 184
- Starts
- 2018-11-20
- Expected to finish
- 2020-04-11
- Last updated by the study team
- 2021-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Spire, Inc. — San Francisco, California, United States
Full record on ClinicalTrials.gov
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