Sensor and Electronic Health Records (EHR) Integration Pilot Study

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Other: electronic diary card

Drug: Salbutamol

Device: Mobile spirometer

Device: Activity monitor

Other: CAT

Device: Device sensor

Other: ACT

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT03357341

207223

HO-17-17827 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

194 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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