Trial Outcomes & Findings for iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children) (NCT NCT02994238)
NCT ID: NCT02994238
Last Updated: 2021-10-14
Results Overview
Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
12 month follow-up assessment
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
Intervention
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
The control group will receive only standardized education.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
127
|
|
Overall Study
COMPLETED
|
125
|
127
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
some patients did not choose to identify sex as either male or female
Baseline characteristics by cohort
| Measure |
Intervention
n=125 Participants
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
n=127 Participants
The control group will receive only standardized education.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
125 Participants
n=125 Participants
|
127 Participants
n=127 Participants
|
252 Participants
n=252 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=125 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=252 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=125 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=252 Participants
|
|
Age, Continuous
|
9.3 Years
STANDARD_DEVIATION 3.2 • n=125 Participants
|
9.2 Years
STANDARD_DEVIATION 3.5 • n=127 Participants
|
9.2 Years
STANDARD_DEVIATION 3.3 • n=252 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=114 Participants • some patients did not choose to identify sex as either male or female
|
39 Participants
n=125 Participants • some patients did not choose to identify sex as either male or female
|
83 Participants
n=239 Participants • some patients did not choose to identify sex as either male or female
|
|
Sex: Female, Male
Male
|
70 Participants
n=114 Participants • some patients did not choose to identify sex as either male or female
|
86 Participants
n=125 Participants • some patients did not choose to identify sex as either male or female
|
156 Participants
n=239 Participants • some patients did not choose to identify sex as either male or female
|
|
Race/Ethnicity, Customized
Non-Hispanic/White %
|
24.0 Percentage of participants
n=125 Participants
|
23.6 Percentage of participants
n=127 Participants
|
47.6 Percentage of participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Black %
|
23.2 Percentage of participants
n=125 Participants
|
33.1 Percentage of participants
n=127 Participants
|
56.3 Percentage of participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Hispanic %
|
40.0 Percentage of participants
n=125 Participants
|
28.4 Percentage of participants
n=127 Participants
|
68.4 Percentage of participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Other Race/Ethnicity %
|
7.2 Percentage of participants
n=125 Participants
|
7.8 Percentage of participants
n=127 Participants
|
15.0 Percentage of participants
n=252 Participants
|
|
Race/Ethnicity, Customized
No Data %
|
5.6 Percentage of participants
n=125 Participants
|
7.1 Percentage of participants
n=127 Participants
|
12.7 Percentage of participants
n=252 Participants
|
|
Region of Enrollment
United States
|
125 Participants
n=125 Participants
|
127 Participants
n=127 Participants
|
252 Participants
n=252 Participants
|
|
Insurance Type
Private Insurance %
|
40 Percentage of participants
n=125 Participants
|
43.3 Percentage of participants
n=127 Participants
|
42.8 Percentage of participants
n=252 Participants
|
|
Insurance Type
Public Insurance %
|
59.2 Percentage of participants
n=125 Participants
|
56.7 Percentage of participants
n=127 Participants
|
57.2 Percentage of participants
n=252 Participants
|
|
ACT Score
|
18.8 units on a scale
STANDARD_DEVIATION 4.5 • n=125 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 3.8 • n=127 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 4.2 • n=252 Participants
|
|
PACQLQ
|
5.7 units on a scale
STANDARD_DEVIATION 1.3 • n=125 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.1 • n=127 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.2 • n=252 Participants
|
PRIMARY outcome
Timeframe: 12 month follow-up assessmentInvestigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).
Outcome measures
| Measure |
Intervention
n=125 Participants
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
n=127 Participants
The control group will receive only standardized education.
|
|---|---|---|
|
Asthma Control Test (ACT)
|
21.8 units on a scale
Standard Error .4
|
19.9 units on a scale
Standard Error .4
|
PRIMARY outcome
Timeframe: the 12 month study periodNumber of Asthma-related ED visits during the 12 month study period
Outcome measures
| Measure |
Intervention
n=125 Participants
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
n=127 Participants
The control group will receive only standardized education.
|
|---|---|---|
|
Frequency of Urgent Health Utilization
|
1.0 events (asthma-related ED visits)
Standard Error .1
|
.6 events (asthma-related ED visits)
Standard Error .1
|
PRIMARY outcome
Timeframe: Over a 12 month study periodNumber of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
Outcome measures
| Measure |
Intervention
n=125 Participants
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
n=127 Participants
The control group will receive only standardized education.
|
|---|---|---|
|
12 Month Rate of Medication Use
|
1.3 OCS Prescriptions
Standard Error .2
|
.9 OCS Prescriptions
Standard Error .2
|
PRIMARY outcome
Timeframe: the 12 month study periodNumber of Asthma-related Hospitalizations during the 12 month study period
Outcome measures
| Measure |
Intervention
n=125 Participants
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
n=127 Participants
The control group will receive only standardized education.
|
|---|---|---|
|
Frequency of Asthma-related Hospitalizations
|
.4 Events (Asthma-related Hospitalizations)
Standard Error .1
|
.1 Events (Asthma-related Hospitalizations)
Standard Error .06
|
SECONDARY outcome
Timeframe: 12 month study follow-upThe Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.
Outcome measures
| Measure |
Intervention
n=125 Participants
The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
|
Control
n=127 Participants
The control group will receive only standardized education.
|
|---|---|---|
|
Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
|
6.3 units on a scale
Standard Deviation 1.0
|
6.0 units on a scale
Standard Deviation 1.4
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Kathy Boon- Clinical Research Associate
Northwestern University
Phone: 312-503-4687
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place