Status:
COMPLETED
Sensor and Electronic Health Records (EHR) Integration Pilot Study
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Geisinger HealthPlan
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18+ years
Brief Summary
This is a pilot study that will evaluate the feasibility of collecting increasing amounts of clinical study data from subjects through sensor and web/app based methods and integrating it with data fro...
Eligibility Criteria
Inclusion
- COPD cohort
- Provide signed and dated informed consent form.
- Be willing to comply with all study procedures and be available for the duration of the study.
- Age \>=40 years
- Diagnosed with COPD, defined as COPD listed on the subject's problem list and one of the following: a) At least one inpatient hospitalization with a COPD diagnosis listed as the primary or secondary diagnosis (J41.x, J42.x, J44.x \[chronic bronchitis\], J43.9 \[emphysema\] or J44.9 \[Chronic obstructive pulmonary disease, unspecified\]) in the last 12 months b) At least two outpatient encounters with a diagnosis of COPD exacerbation (J44.1), Acute bronchitis (J20.x), or bronchitis (J40) listed as the primary or secondary diagnosis, with different dates of service in the last 12 months c) At least one emergency room encounter with a COPD diagnosis (J41.x, J42.x, J44.x, J43.9, J44.9) listed as the primary or secondary diagnosis in the last 12 months d) At least two urgent care encounters with different dates of service, with a COPD diagnosis (J41.x, J42.x, J44.x, J43.9, J44.9) listed as the primary or secondary diagnosis in the last 12 months.
- At least one order for an inhaled COPD medication during the prior year.
- More than 12 months of data available in the integrated EHR data prior to date of screening.
- Asthma cohort
- Provide signed and dated informed consent form.
- Be willing to comply with all study procedures and be available for the duration of the study.
- Age \>=18 years
- Diagnosed with asthma, defined as asthma listed on the subject's problem list and one of the following: a) At least one inpatient hospitalization with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months. b) At least one emergency room encounter with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months c) at least two urgent care encounters, with different dates of service, with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months d) At least three or more prescriptions or prescription refills in the past 12 months for any combination of the following: an inhaled glucocorticoid with or without a second controller (Montelukast, Theophylline, a long-acting beta agonist \[LABA\] alone) or a combination drug with a LABA and an inhaled glucocorticoid.
- More than 12 months of data available in the integrated EHR data prior to date of screening.
Exclusion
- COPD cohort
- Inability/Unwillingness to use the required devices, or
- Inability to read and understand English Asthma cohort
- Inability/Unwillingness to use the required devices
- Inability to read and understand English
- Diagnosis of COPD listed on problem list
Key Trial Info
Start Date :
July 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 27 2019
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03357341
Start Date
July 23 2018
End Date
September 27 2019
Last Update
November 24 2020
Active Locations (1)
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1
GSK Investigational Site
Danville, Pennsylvania, United States, 17822