Last updated: 11/24/2020 12:10:10

Sensor and electronic health records (EHR) Integration Pilot Study

GSK study ID
207223
See study documents
Clinicaltrials.gov ID
NCT03357341
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study
Trial description: 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 purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from baseline in forced expiratory volume in one second (FEV1)

Timeframe: Up to 6 months

Mean number of steps per day

Timeframe: Up to 6 months

Mean daily activity level based on vector magnitude units (VMUs)

Timeframe: Up to 6 months

Patient reported outcome (PRO)active total score

Timeframe: Up to 6 months

PROactive difficulty domain score

Timeframe: Up to 6 months

Number of subjects with COPD exacerbations as determined by evaluating respiratory symptoms (E-RS) in COPD-COPD cohort

Timeframe: Up to 6 months

Mean number of primary care visits- COPD cohort

Timeframe: Up to 6 months

Mean number of primary care visits-asthma cohort

Timeframe: Up to 6 months

Mean number of secondary care visits-COPD cohort

Timeframe: Up to 6 months

Mean number of secondary care visits-asthma cohort

Timeframe: Up to 6 months

Mean number of all primary care visits

Timeframe: Up to 6 months

Mean number of all secondary care visits

Timeframe: Up to 6 months

Number of subjects with new prescriptions-COPD cohort

Timeframe: Up to 6 months

Number of subjects with new prescriptions-asthma cohort

Timeframe: Up to 6 months

Number of days in hospital-COPD cohort

Timeframe: Up to 6 months

Number of days in hospital-asthma cohort

Timeframe: Up to 6 months

Number of albuterol inhalers prescribed-COPD cohort

Timeframe: Up to 6 months

Number of albuterol inhalers prescribed-asthma cohort

Timeframe: Up to 6 months

Mean change from baseline in COPD assessment test (CAT) score-COPD cohort

Timeframe: Up to 6 months

Mean change from baseline in asthma control test (ACT) score-asthma cohort

Timeframe: Up to 6 months

Number of subjects with rescue medication use

Timeframe: Up to 6 months

Number of subjects using maintenance therapy

Timeframe: Up to 6 months

Number of feedbacks obtained through exit interview

Timeframe: At 6 months

Secondary outcomes:
Not applicable
Interventions:
  • Device: Mobile spirometer
  • Device: Device sensor
  • Drug: Salbutamol
  • Device: Activity monitor
  • Other: electronic diary card
  • Other: CAT
  • Other: ACT
    • Enrollment:
    194
    Primary completion date:
    2019-27-09
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    danirixin
    Collaborators
    Geisinger HealthPlan
    Study date(s)
    July 2018 to September 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • COPD cohort
    • Provide signed and dated informed consent form.
    • COPD cohort
    • Inability/Unwillingness to use the required devices, or
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Danville, Pennsylvania, United States, 17822
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2019-27-09
    Actual study completion date
    2019-27-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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