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Sensor and Electronic Health Records (EHR) Integration Pilot Study

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ClinicalTrials.gov Identifier: NCT03357341
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Geisinger HealthPlan
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Device: Mobile spirometer Device: Device sensor Drug: Salbutamol Device: Activity monitor Other: electronic diary card Other: CAT Other: ACT

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : April 26, 2019
Estimated Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
COPD cohort
Approximately 100 subjects with COPD identified through integrated EHR records will be enrolled.
Device: Mobile spirometer
Mobile spirometer will be used to measure FEV1 values weekly.

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

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

Device: Activity monitor
Subjects will be required to wear activity monitors daily to record their physical activity.

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

Other: CAT
Subjects will be required to complete CAT monthly.

Asthma cohort
Approximately 100 subjects with asthma identified through integrated EHR records will be enrolled.
Device: Mobile spirometer
Mobile spirometer will be used to measure FEV1 values weekly.

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

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

Device: Activity monitor
Subjects will be required to wear activity monitors daily to record their physical activity.

Other: ACT
Subjects will be required to complete ACT monthly.




Primary Outcome Measures :
  1. Change from baseline in forced expiratory volume in one second (FEV1) [ Time Frame: Up to 6 months ]
    FEV1 will be measured using a mobile spirometry device.

  2. Mean number of steps per day [ Time Frame: Up to 6 months ]
    The physical activity will be assessed by a physical activity monitor.

  3. Mean daily activity level based on vector magnitude units (VMUs) [ Time Frame: Up to 6 months ]
    The physical activity will be assessed by a physical activity monitor.

  4. Patient reported outcome (PRO)active total score [ Time Frame: Up to 6 months ]
    Subject reported physical activity will be analyzed based on PROactive total scores using the clinical visit version of PROactive Physical Activity in COPD (C-PPAC).

  5. PROactive difficulty domain score [ Time Frame: Up to 6 months ]
    PROactive difficulty domain score will be summarized using C-PPAC.

  6. Number of subjects with COPD exacerbations as determined by evaluating respiratory symptoms (E-RS) in COPD-COPD cohort [ Time Frame: Up to 6 months ]
    The E-RS: COPD scale is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS utilizes the 11 respiratory symptom items contained in the 14-item Exacerbations of Chronic pulmonary disease Tool (EXACT).

  7. Mean number of primary care visits- COPD cohort [ Time Frame: Up to 6 months ]
    The mean number of primary care visits for COPD conditions will be summarized using data from EHR-based healthcare utilization.

  8. Mean number of primary care visits-asthma cohort [ Time Frame: Up to 6 months ]
    The mean number of primary care visits for asthma conditions will be summarized using data from EHR-based healthcare utilization.

  9. Mean number of secondary care visits-COPD cohort [ Time Frame: Up to 6 months ]
    The mean number of secondary care visits (that is, inpatient, urgent care and emergency department [ED] visits) for COPD conditions will be summarized using data from EHR-based healthcare utilization.

  10. Mean number of secondary care visits-asthma cohort [ Time Frame: Up to 6 months ]
    The mean number of secondary care visits (that is, inpatient, urgent care and ED visits) for asthma conditions will be summarized using data from EHR-based healthcare utilization.

  11. Mean number of all primary care visits [ Time Frame: Up to 6 months ]
    The mean number of all primary care visits will be summarized using data from EHR-based healthcare utilization.

  12. Mean number of all secondary care visits [ Time Frame: Up to 6 months ]
    The mean number of all secondary care visits (that is, inpatient, urgent care and ED visits) will be summarized using data from EHR-based healthcare utilization.

  13. Number of subjects with new prescriptions-COPD cohort [ Time Frame: Up to 6 months ]
    New treatments prescribed for COPD will be summarized using data from EHR-based healthcare utilization.

  14. Number of subjects with new prescriptions-asthma cohort [ Time Frame: Up to 6 months ]
    New treatments prescribed for asthma will be summarized using data from EHR-based healthcare utilization.

  15. Number of days in hospital-COPD cohort [ Time Frame: Up to 6 months ]
    The number of days for which the subject was hospitalized for COPD will be summarized using data from EHR-based healthcare utilization.

  16. Number of days in hospital-asthma cohort [ Time Frame: Up to 6 months ]
    The number of days for which the subject was hospitalized for asthma will be summarized using data from EHR-based healthcare utilization.

  17. Number of albuterol inhalers prescribed-COPD cohort [ Time Frame: Up to 6 months ]
    The total number of albuterol inhalers (adjusted to equivalence of 200 actuations) prescribed for subjects with COPD will be summarized.

  18. Number of albuterol inhalers prescribed-asthma cohort [ Time Frame: Up to 6 months ]
    The total number of albuterol inhalers (adjusted to equivalence of 200 actuations) prescribed for subjects with asthma will be summarized.

  19. Mean change from baseline in COPD assessment test (CAT) score-COPD cohort [ Time Frame: Up to 6 months ]
    The subject reported outcomes will be evaluated on the basis of CAT scores and will be collected via electronic platform.

  20. Mean change from baseline in asthma control test (ACT) score-asthma cohort [ Time Frame: Up to 6 months ]
    The subject reported outcomes will be evaluated on the basis of ACT scores and will be collected via electronic platform.

  21. Number of subjects with rescue medication use [ Time Frame: Up to 6 months ]
    The use of rescue medication by subjects will be monitored by attaching a sensor to rescue inhaler.

  22. Number of subjects using maintenance therapy [ Time Frame: Up to 6 months ]
    The use of maintenance therapy by subjects will be monitored by attaching a sensor to maintenance inhaler.

  23. Number of feedbacks obtained through exit interview [ Time Frame: At 6 months ]
    An exit interview will be conducted by Geisinger personnel to obtain relevant feedback from subjects regarding the study, study devices and electronic PRO platform.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two cohorts consisting of approximately 100 subjects each with COPD and asthma identified through EHR database analyses will be included.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357341


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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United States, Pennsylvania
GSK Investigational Site Recruiting
Danville, Pennsylvania, United States, 17822
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Geisinger HealthPlan
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03357341     History of Changes
Other Study ID Numbers: 207223
HO-17-17827 ( Other Identifier: Track HO identifier )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by GlaxoSmithKline:
electronic health record
Pilot
COPD
Sensor
Asthma

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action