Sensor and Electronic Health Records (EHR) Integration Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2019 |
| Start Date: | July 23, 2018 |
| End Date: | April 26, 2019 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study
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 from their EHR to facilitate more efficient and meaningful research with acceptable
quality. Approximately 100 subjects with asthma and 100 subjects with chronic obstructive
pulmonary disease (COPD) will be enrolled in this prospective study. The subjects will be
identified through integrated EHR records following which eligible subjects will receive
study devices and training on proper use of the devices at Baseline visit. Data will be
collected remotely from subject reports, devices and sensors over six months.
clinical study data from subjects through sensor and web/app based methods and integrating it
with data from their EHR to facilitate more efficient and meaningful research with acceptable
quality. Approximately 100 subjects with asthma and 100 subjects with chronic obstructive
pulmonary disease (COPD) will be enrolled in this prospective study. The subjects will be
identified through integrated EHR records following which eligible subjects will receive
study devices and training on proper use of the devices at Baseline visit. Data will be
collected remotely from subject reports, devices and sensors over six months.
Inclusion Criteria:
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 Criteria:
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
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