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NCT03357341 · ClinicalTrials.gov registry record
Sensor and Electronic Health Records (EHR) Integration Pilot Study
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 194
- Enrollment target
NCT03357341: Completed study, sponsored by GlaxoSmithKline.
NCT03357341 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 194 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03357341 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 194 participants
- Enrollment target
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.
Primary Outcome
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Participants were given a hand-held spirometer with instructions on its proper use. Baseline (Week 1) measurement was taken in clinic and the participants were instructed to perform home spirometry on a weekly basis for the remainder of the study. The spirometry use was linked to the Propeller Health application o
Interventions
- DRUG Salbutamol
- DEVICE Activity monitor
- DEVICE Mobile spirometer
- DEVICE Device sensor
- OTHER electronic diary card
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2019-09-27 |
What the finished NCT03357341 record still lists
NCT03357341 is an observational study that tracks outcomes without assigning an intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Salbutamol is the first listed.
NCT03357341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03357341 about?
NCT03357341 is a clinical study titled "Sensor and Electronic Health Records (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. Approximat...
What is the current status of trial NCT03357341?
This trial is currently completed. The enrollment target is 194 participants. The study started on 2018-07-23. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT03357341?
The interventions under investigation include: Salbutamol (DRUG), Activity monitor (DEVICE), Mobile spirometer (DEVICE), Device sensor (DEVICE), electronic diary card (OTHER).
Who is sponsoring clinical trial NCT03357341?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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