Trial Outcomes & Findings for Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma (NCT NCT02517047)

Last Updated: 2018-06-07

Results Overview

Total number participants who took their medication as planned will be measured. This will include measuring the number of participants with medication compliance who take their medications as planned based on the data from the monitoring device.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	CareTRx Device Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app. CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CareTRx Device n=26 Participants Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app. CareTRx: CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.
Age, Categorical <=18 years	26 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=113 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants
Age, Continuous	9.1 years n=113 Participants
Sex: Female, Male Female	10 Participants n=113 Participants
Sex: Female, Male Male	16 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	12 Participants n=113 Participants
Race (NIH/OMB) White	11 Participants n=113 Participants
Race (NIH/OMB) More than one race	3 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Region of Enrollment United States	26 Participants n=113 Participants
Asthma control test	20.6 units on a scale STANDARD_DEVIATION 3.5 • n=113 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	CareTRx Device n=24 Participants All eligible participants will receive CareTRx device for control inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app. All data in the table represent values collected during the study and no placeholder values were used.
Number of Participants With Daily Medication Compliance	24 Participants

PRIMARY outcome

Timeframe: 12 weeks

Total number participants with rescue inhaler use throughout the course of the study.

Outcome measures

Outcome measures
Measure	CareTRx Device n=24 Participants All eligible participants will receive CareTRx device for control inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app. All data in the table represent values collected during the study and no placeholder values were used.
Number of Participants With Rescue Inhaler Use	24 Participants

SECONDARY outcome

Timeframe: 12 weeks

Asthma symptom control as a measure of effectiveness of self-management behavior on asthma control, measured by Asthma Control Test (ACT). Asthma control test is a survey used to evaluate asthma control in patients. It includes 5 multiple questions that ask about how much of the time patient was having asthma symptoms. The higher the score the better asthma control. Lower scores especially less than 19 represent poor asthma control. each question has 5 answers. The total score is the sum of all the scores from 5 questions. the maximum score on the test is 25 which is excellent asthma control and the lowest is 0 which defines extremely poor asthma control.

Outcome measures

Outcome measures
Measure	CareTRx Device n=24 Participants All eligible participants will receive CareTRx device for control inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app. All data in the table represent values collected during the study and no placeholder values were used.
Asthma Symptoms	21.6 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline

Forced expiratory volume measured in liters is the volume of air which can be forcibly exhaled from the lungs in the first second of a forced expiration and helps with evaluation of asthma control. FEV1 was only measure at baseline to assess the participants asthma status at baseline.

Outcome measures

Outcome measures
Measure	CareTRx Device n=24 Participants All eligible participants will receive CareTRx device for control inhaler as well as the application downloaded to their Android phone. CareTRx is a novel monitoring device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide information to patients and providers around medication adherence and disease control in pediatric asthma. The information will then be loaded to phone app. All data in the table represent values collected during the study and no placeholder values were used.
Forced Expiratory Volume	1.56 liters Standard Deviation 0.62

Adverse Events

CareTRx Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wanda Phipatanakul

Boston Children's Hospital

Phone: 6173556117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place