Sensor and Electronic Health Records (EHR) Integration Pilot Study

November 23, 2020 updated by: GlaxoSmithKline

Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Time Frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Participants were given a hand-held spirometer with instructions on its proper use. Baseline (Week 1) measurement was taken in clinic and the participants were instructed to perform home spirometry on a weekly basis for the remainder of the study. The spirometry use was linked to the Propeller Health application on the iPad, which provided visual cues for the spirometry and sent the data to the central database after completion of the session. Change from Baseline was calculated as the value at specified time point minus Baseline value. Change from Baseline in FEV1 at 4-weekly intervals is presented.
Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Median Number of Steps Per Day
Time Frame: Weeks 1, 5, 9, 13, 17, 21 and 25
The physical activity was captured using a waist-worn accelerometer. A valid day was defined as a day where the activity monitor detected that it was worn for at least 8 hours during that day. Data for three or more valid days were required to generate data for weekly step counts.
Weeks 1, 5, 9, 13, 17, 21 and 25
Median Daily Activity Level Based on Vector Magnitude Counts.
Time Frame: Weeks 1, 5, 9, 13, 17, 21 and 25
The physical activity was captured using a waist-worn accelerometer. Vector magnitude in counts are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity.
Weeks 1, 5, 9, 13, 17, 21 and 25
Patient Reported Outcome (PRO) Active Total Score
Time Frame: Weeks 2, 6, 10, 14, 18, 22 and 26
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of PRO was used, and was offered via the participant's electronic PRO application every 28 days. This version of PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'amount' domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute [VMU/min] and steps per day). The 'difficulty' domain is covered by 10 items. Each domain score is based on the simple addition of items (scale ranging from 0 to 15 for amount domain and 0 to 40 for difficulty domain), and then scaled from 0 to 100. 'Total Score' is calculated as the sum of the two domains (amount and difficulty) divided by two, thus scored from 0 (worse) to 100 (much better).
Weeks 2, 6, 10, 14, 18, 22 and 26
PROactive Amount Domain Score
Time Frame: Weeks 2, 6, 10, 14, 18, 22 and 26
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains (amount and difficulty). The amount domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute [VMU/min] and steps per day). Amount domain score is based on the simple addition of items (scale ranging from 0 to 15) and then scaled from 0 to 100.
Weeks 2, 6, 10, 14, 18, 22 and 26
PROactive Difficulty Domain Score
Time Frame: Weeks 2, 6, 10, 14, 18, 22 and 26
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'difficulty' domain is covered by 10 items. The difficulty domain score is based on the simple addition of items (0 to 40), which is then scaled from 0 (worse) to 100 (much better).
Weeks 2, 6, 10, 14, 18, 22 and 26
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Time Frame: Weeks 1, 5, 9, 13, 17, 21 and 25
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). For the COPD cohort specifically, the daily EXACT was offered each evening. The domains included: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score was derived by summing the 11-item scores and ranged between 0-40 with higher values indicating severe respiratory symptoms. Scores for the week were summarized for each COPD participant where they completed the questionnaire on three or more days during the study week
Weeks 1, 5, 9, 13, 17, 21 and 25
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only
Time Frame: Up to 6 months
EXACT is a 14-item diary that measures respiratory symptoms and function. The total score for EXACT ranges from 0-100, higher scores indicate more severe symptoms. EXACT events are considered worsening of symptom scores above the individual's Baseline value over multiple consecutive days.
Up to 6 months
Number of Primary Care Visits for Asthma Conditions or COPD
Time Frame: Up to 6 months
The number of primary care visits (including ambulatory, home and phone) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization.
Up to 6 months
Number of Secondary Care Visits for Asthma Conditions or COPD
Time Frame: Up to 6 months
The number of secondary care visits (that is, inpatient hospitalization and emergency department [ED]) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization
Up to 6 months
Number of All Primary Care Visits
Time Frame: Up to 6 months
The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization
Up to 6 months
Number of All Secondary Care Visits
Time Frame: Up to 6 months
The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization
Up to 6 months
Number of Participants With New Prescriptions
Time Frame: Up to 6 months
New treatments that were prescribed for respiratory-related conditions (Short-acting beta-agonists [SABA], Inhaled corticosteroid (ICS)/long-acting beta-agonist [LABA] combinations, Oral corticosteroids [OCS], Leukotriene modifiers [LEUK], ICS, Long-acting muscarinic antagonists [LAMA], SABA/short-acting muscarinic antagonist [SAMA] combinations, Anti-cholinergics [a-CHOL], LABA/LAMA, ICS/LABA/LAMA, Phosphodiesterase type 4 inhibitors [PDE4], Anti-immunoglobulin E [a-IgE], LABA, and Interleukin-5 inhibitors [IL-5]) were summarized using data from EHR-based healthcare utilization. Some participants may have received prescriptions in more than one medication category.
Up to 6 months
Number of Days in Hospital for Asthma and COPD
Time Frame: Up to 6 months
The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization
Up to 6 months
Number of Participants Who Received Short-acting Beta-agonist Therapy
Time Frame: Up to 6 months
Participants who received SABA were summarized using data from EHR-based healthcare utilization.
Up to 6 months
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Time Frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment). Total score was calculated by summing the non-missing scores on the eight items and ranged from 0-40. Higher scores indicated greater disease impact. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Time Frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale (1 to 5). Total score was calculated as the sum of scores from 5 questions and ranged from 5 to 25. Higher scores indicated better control of asthma. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Median Rescue Medication Use
Time Frame: Weeks 1, 5, 9, 13, 17, 21, 25
The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler.
Weeks 1, 5, 9, 13, 17, 21, 25
Percentage of Participants With Maintenance Compliance
Time Frame: Weeks 1, 5, 9, 13, 17, 21 and 25
The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler.
Weeks 1, 5, 9, 13, 17, 21 and 25
Number of Participants Who Completed Exit Interview
Time Frame: Up to 6 Months
An exit interview were conducted to obtain relevant feedback from participants regarding the study, study devices and electronic PRO platform. Exit surveys were triggered via the study-supplied iPad to each participant when they completed (or withdrew from) the study.
Up to 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Geisinger HealthPlan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 207223
  • HO-17-17827 (Other Identifier: Track HO identifier)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Mobile spirometer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings