NCT03357341

Sensor and Electronic Health Records (EHR) Integration Pilot Study

Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-09-27
• Completion: 2019-09-27
• First posted: 2017-11-29
• Last updated: 2020-11-24
• Results posted: 2020-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study