At a glance
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Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study
In Brief
An observational study evaluating Mobile spirometer, Device sensor, and 5 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 194 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Mobile spirometer will be used to measure FEV1 values weekly.
Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.
Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.
Subjects will be required to wear activity monitors daily to record their physical activity.
Electronic diary card will be completed daily by subjects in COPD cohort.
Subjects will be required to complete CAT monthly.
Subjects will be required to complete ACT monthly.