Sensor and Electronic Health Records (EHR) Integration Pilot Study

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 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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

Mobile spirometer

Mobile spirometer will be used to measure FEV1 values weekly.

DEVICE

Device sensor

Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.

DRUG

Salbutamol

Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.

DEVICE

Activity monitor

Subjects will be required to wear activity monitors daily to record their physical activity.

OTHER

electronic diary card

Electronic diary card will be completed daily by subjects in COPD cohort.

OTHER

CAT

Subjects will be required to complete CAT monthly.

OTHER

ACT

Subjects will be required to complete ACT monthly.

Sponsors & Collaborators

• Geisinger HealthPlan

  collaborator INDUSTRY

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-23

Primary Completion

2019-09-27

Completion

2019-09-27

FDA Device

Yes

Countries

• United States

Study Locations