Clinical trial NCT03357341: Sensor and Electronic Health Records (EHR) Integration Pilot Study
Official title: Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: electronic health record
Pilot
COPD
Sensor
Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Geisinger HealthPlan
First posted: 2017-11-29
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
measure: Median Number of Steps Per Day
timeFrame: Weeks 1, 5, 9, 13, 17, 21 and 25
measure: Median Daily Activity Level Based on Vector Magnitude Counts.
timeFrame: Weeks 1, 5, 9, 13, 17, 21 and 25
measure: Patient Reported Outcome (PRO) Active Total Score
timeFrame: Weeks 2, 6, 10, 14, 18, 22 and 26
measure: PROactive Amount Domain Score
timeFrame: Weeks 2, 6, 10, 14, 18, 22 and 26
measure: PROactive Difficulty Domain Score
timeFrame: Weeks 2, 6, 10, 14, 18, 22 and 26
measure: Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
timeFrame: Weeks 1, 5, 9, 13, 17, 21 and 25
measure: Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only
timeFrame: Up to 6 months
measure: Number of Primary Care Visits for Asthma Conditions or COPD
timeFrame: Up to 6 months
measure: Number of Secondary Care Visits for Asthma Conditions or COPD
timeFrame: Up to 6 months
measure: Number of All Primary Care Visits
timeFrame: Up to 6 months
measure: Number of All Secondary Care Visits
timeFrame: Up to 6 months
measure: Number of Participants With New Prescriptions
timeFrame: Up to 6 months
measure: Number of Days in Hospital for Asthma and COPD
timeFrame: Up to 6 months
measure: Number of Participants Who Received Short-acting Beta-agonist Therapy
timeFrame: Up to 6 months
measure: Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
timeFrame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
measure: Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
timeFrame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
measure: Median Rescue Medication Use
timeFrame: Weeks 1, 5, 9, 13, 17, 21, 25
measure: Percentage of Participants With Maintenance Compliance
timeFrame: Weeks 1, 5, 9, 13, 17, 21 and 25
measure: Number of Participants Who Completed Exit Interview
timeFrame: Up to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: