Last updated: 11/24/2020 12:10:10
Sensor and electronic health records (EHR) Integration Pilot Study
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2019-27-09
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
GSK Investigational Site
Danville, Pennsylvania, United States, 17822
Status
Study Complete
Study documents
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website