Sensor and Electronic Health Records (EHR) Integration Pilot Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Two cohorts consisting of approximately 100 subjects each with COPD and asthma identified through EHR database analyses will be included.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Pulmonary Disease, Chronic Obstructive

Being tested

Mobile spirometer, Device sensor, Salbutamol, Activity monitor, electronic diary card

Keywords

electronic health record, Pilot, COPD, Sensor, Asthma

Medical subject headings

Pulmonary Disease, Chronic Obstructive, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Mobile spirometerDevice

  Mobile spirometer will be used to measure FEV1 values weekly.

• Device sensorDevice

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

• SalbutamolDrug

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

• Activity monitorDevice

  Subjects will be required to wear activity monitors daily to record their physical activity.

• electronic diary cardOther

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

• CATOther

  Subjects will be required to complete CAT monthly.

• ACTOther

  Subjects will be required to complete ACT monthly.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

   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.

   Measured: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25

2. Median Number of Steps Per Day

   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.

   Measured: Weeks 1, 5, 9, 13, 17, 21 and 25

3. Median Daily Activity Level Based on Vector Magnitude Counts.

   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.

   Measured: Weeks 1, 5, 9, 13, 17, 21 and 25

4. Patient Reported Outcome (PRO) Active Total Score

   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).

   Measured: Weeks 2, 6, 10, 14, 18, 22 and 26

5. PROactive Amount Domain Score

   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.

   Measured: Weeks 2, 6, 10, 14, 18, 22 and 26

6. PROactive Difficulty Domain Score

   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).

   Measured: Weeks 2, 6, 10, 14, 18, 22 and 26

7. Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only

   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

   Measured: Weeks 1, 5, 9, 13, 17, 21 and 25

8. Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only

   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.

   Measured: Up to 6 months

9. Number of Primary Care Visits for Asthma Conditions or COPD

   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.

   Measured: Up to 6 months

10. Number of Secondary Care Visits for Asthma Conditions or COPD

    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

    Measured: Up to 6 months

11. Number of All Primary Care Visits

    The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization

    Measured: Up to 6 months

12. Number of All Secondary Care Visits

    The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization

    Measured: Up to 6 months

13. Number of Participants With New Prescriptions

    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.

    Measured: Up to 6 months

14. Number of Days in Hospital for Asthma and COPD

    The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization

    Measured: Up to 6 months

15. Number of Participants Who Received Short-acting Beta-agonist Therapy

    Participants who received SABA were summarized using data from EHR-based healthcare utilization.

    Measured: Up to 6 months

16. Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only

    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.

    Measured: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25

17. Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only

    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.

    Measured: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25

18. Median Rescue Medication Use

    The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler.

    Measured: Weeks 1, 5, 9, 13, 17, 21, 25

19. Percentage of Participants With Maintenance Compliance

    The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler.

    Measured: Weeks 1, 5, 9, 13, 17, 21 and 25

20. Number of Participants Who Completed Exit Interview

    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.

    Measured: Up to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Nov 2017
2. Study start23 Jul 2018
3. Primary completion27 Sep 2019
4. Study completion27 Sep 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
• More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.