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Sensor and Electronic Health Records (EHR) Integration Pilot Study

NCT ID: NCT03357341

Last Updated: 2020-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-23

Study Completion Date

2019-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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electronic health record Pilot COPD Sensor Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD cohort

Approximately 100 subjects with COPD identified through integrated EHR records will be enrolled.

Mobile spirometer

Intervention Type DEVICE

Mobile spirometer will be used to measure FEV1 values weekly.

Device sensor

Intervention Type DEVICE

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

Salbutamol

Intervention Type DRUG

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

Activity monitor

Intervention Type DEVICE

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

electronic diary card

Intervention Type OTHER

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

CAT

Intervention Type OTHER

Subjects will be required to complete CAT monthly.

Asthma cohort

Approximately 100 subjects with asthma identified through integrated EHR records will be enrolled.

Mobile spirometer

Intervention Type DEVICE

Mobile spirometer will be used to measure FEV1 values weekly.

Device sensor

Intervention Type DEVICE

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

Salbutamol

Intervention Type DRUG

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

Activity monitor

Intervention Type DEVICE

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

ACT

Intervention Type OTHER

Subjects will be required to complete ACT monthly.

Interventions

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Mobile spirometer

Mobile spirometer will be used to measure FEV1 values weekly.

Intervention Type DEVICE

Device sensor

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

Intervention Type DEVICE

Salbutamol

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

Intervention Type DRUG

Activity monitor

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

Intervention Type DEVICE

electronic diary card

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

Intervention Type OTHER

CAT

Subjects will be required to complete CAT monthly.

Intervention Type OTHER

ACT

Subjects will be required to complete ACT monthly.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

COPD cohort

* Provide signed and dated informed consent form.
* Be willing to comply with all study procedures and be available for the duration of the study.
* Age \>=40 years
* Diagnosed with COPD, defined as COPD listed on the subject's problem list and one of the following: a) At least one inpatient hospitalization with a COPD diagnosis listed as the primary or secondary diagnosis (J41.x, J42.x, J44.x \[chronic bronchitis\], J43.9 \[emphysema\] or J44.9 \[Chronic obstructive pulmonary disease, unspecified\]) in the last 12 months b) At least two outpatient encounters with a diagnosis of COPD exacerbation (J44.1), Acute bronchitis (J20.x), or bronchitis (J40) listed as the primary or secondary diagnosis, with different dates of service in the last 12 months c) At least one emergency room encounter with a COPD diagnosis (J41.x, J42.x, J44.x, J43.9, J44.9) listed as the primary or secondary diagnosis in the last 12 months d) At least two urgent care encounters with different dates of service, with a COPD diagnosis (J41.x, J42.x, J44.x, J43.9, J44.9) listed as the primary or secondary diagnosis in the last 12 months.
* At least one order for an inhaled COPD medication during the prior year.
* More than 12 months of data available in the integrated EHR data prior to date of screening.

Asthma cohort

* Provide signed and dated informed consent form.
* Be willing to comply with all study procedures and be available for the duration of the study.
* Age \>=18 years
* Diagnosed with asthma, defined as asthma listed on the subject's problem list and one of the following: a) At least one inpatient hospitalization with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months. b) At least one emergency room encounter with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months c) at least two urgent care encounters, with different dates of service, with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months d) At least three or more prescriptions or prescription refills in the past 12 months for any combination of the following: an inhaled glucocorticoid with or without a second controller (Montelukast, Theophylline, a long-acting beta agonist \[LABA\] alone) or a combination drug with a LABA and an inhaled glucocorticoid.
* More than 12 months of data available in the integrated EHR data prior to date of screening.

Exclusion Criteria

COPD cohort

* Inability/Unwillingness to use the required devices, or
* Inability to read and understand English Asthma cohort
* Inability/Unwillingness to use the required devices
* Inability to read and understand English
* Diagnosis of COPD listed on problem list
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geisinger HealthPlan

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Danville, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HO-17-17827

Identifier Type: OTHER

Identifier Source: secondary_id

207223

Identifier Type: -

Identifier Source: org_study_id