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Device

Sensor and Electronic Health Records (EHR) Integration Pilot Study

N/A
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
+17 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: COPD cohortExperimental Treatment6 Interventions
Approximately 100 subjects with COPD identified through integrated EHR records will be enrolled.
Group II: Asthma cohortExperimental Treatment5 Interventions
Approximately 100 subjects with asthma identified through integrated EHR records will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Device sensor
2018
N/A
~200
Activity monitor
2010
N/A
~620
Mobile spirometer
2018
N/A
~200
Salbutamol
FDA approved

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,383,996 Total Patients Enrolled
Geisinger HealthPlanUNKNOWN
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,365 Total Patients Enrolled
~26 spots leftby Jan 2026
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