iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)

• Sponsor: Dr. Deneen Vojta (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02994238
• Collaborator: Northwestern University (Other)
• Enrollment: 252
• Arms: 2
• Actual Duration (Months): 25

Study Details

Study Description

Brief Summary

The goal of this study is to determine whether a sensor-enabled, clinically integrated, mobile health asthma program can improve asthma outcomes among 4-17 year old children with moderate-to-severe asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: Remote Health Management Sensor Platform	N/A

Detailed Description

Primary Aims:

• Assess whether asthma control in patients enrolled in the intervention arm improved in comparison to the control arm through the (ACT) measurement tool.

• Assess healthcare utilization (asthma-related ED visits and hospitalizations, asthma-related oral corticosteroid use) obtained through electronic medical record and parent report.

Secondary Aims:

Investigators will use parent-report surveys of the following psycho-social outcome measures:

• Days missed from school due to asthma; 2) pediatric asthma-related quality of life (PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE).

• Enhance parental management through improved inhaler use. The investigators will use the Propeller Sensor Platform (referenced as Remote Health Management Platform) to allow parents to track their child's ICS and SABA inhaler use daily. The Platform also will have specific educational messaging to help parents and their children achieve adherence to their prescribed plan. This constant feedback and reinforcement may lead to improved asthma control therefore reducing frequency and severity of asthma exacerbations. The investigators will also be assessing the factors associated with the feasibility and sustainability of the Propeller Sensor Platform by observing trends in utilization. Utilization and drop-off will be measured by monitoring use of the inhalers and periodic surveys of families.

• Improve management by the healthcare team. The investigators will use the Remote Health Management Platform to integrate inhaler use data into a web portal that the physician's office can access. Through the development of this interface, the Propeller Sensor Platform will be able to provide inhaler use feedback to healthcare teams.

Types of feedback:

• Emergency Management: data on inhaled corticosteroids (ICS) and short-acting beta-agonist (SABA) use

• Long-term Management: data on ICS and SABA use. This interface will include data on both ICS and SABA inhaler use. The interface will also have flags to notify the office of under or overuse of inhalers, with a protocol in place to reach out to patients. The investigators will also be assessing the factors associated with the feasibility and sustainability of the Remote Health Management Platform by the healthcare team. This will be done by weekly contact with the healthcare team, rapid cycle improvement of the web portal, and written assessments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Device: 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.; Other Names: Reciprocal Labs Propeller Health Systems
No Intervention: Control The control group will receive only standardized education.

Outcome Measures

Primary Outcome Measures

1. Asthma Control Test (ACT) [12 month follow-up assessment]

   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).

2. Frequency of Urgent Health Utilization [the 12 month study period]

   Number of Asthma-related ED visits during the 12 month study period

3. 12 Month Rate of Medication Use [Over a 12 month study period]

   Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report

4. Frequency of Asthma-related Hospitalizations [the 12 month study period]

   Number of Asthma-related Hospitalizations during the 12 month study period

Secondary Outcome Measures

1. Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire [12 month study follow-up]

   The 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• English-speaking parents

• Children 4-<17 years of age. Using both NHLBI (National Heart, Lung, and Blood Institute) guidelines and based off of a physician expert panel, the research team has limited the ages to 4-<17 years old. It has been shown to be difficult to properly diagnose individuals less than 4 years of age with asthma. Usually, they are diagnosed with reactive airway disease or bronchial virus. Individuals <17 years old was the oldest group because investigators wanted to avoid adolescence and make sure that parents have an active role in the health management of the child.

• Moderate or severe persistent asthma, defined by the National Heart, Lung, and Blood Institute. This will be done by a physician-trained research assistant who will be able to identify potential participants prior to recruitment.

• At least one asthma exacerbations that required a course of oral corticosteroids in the past year

• Prescription and utilization of an ICS inhaler for at least the past year.

• Who are seen at: Clark and Deming Resident Clinic, Lurie Children's Pulmonary Clinic, Lurie Children's Uptown Clinic, Chicago Family Asthma and Allergy Clinic or Children's Healthcare Associates

Exclusion Criteria:

• Non-English speaking parents/families

• Patients seen in the hospital who receive primary care outside of the study's clinics

• Children with any comorbid conditions, which interfere with appropriate assessment of asthma symptoms: Chronic Lung Disease, Broncho-Pulmonary Dysplasia, Cystic Fibrosis, Pulmonary Hypertension, Interstitial Lung Disease, Immunodeficiency, Bronchiectasis, Primary Ciliary Dyskinesia, Chronic Respiratory Insufficiency, Neuromuscular Weakness, Sickle Cell Lung Disease, Restrictive Lung Disease, and Tracheostomy or Ventilator-dependence

• Child-patients who are participating in any other research studies that would interfere with our ability to use and track the inhaler sensor

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dr. Deneen Vojta
• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 6, 2020
• Statistical Analysis Plan - Apr 6, 2020

More Information

Publications

None provided.

• Responsible Party: Dr. Deneen Vojta, Executive Vice President, Research and Development, UnitedHealth Group, UnitedHealth Group
• ClinicalTrials.gov Identifier: NCT02994238
• Other Study ID Numbers: IRB 2016-698
• First Posted: Dec 15, 2016
• Last Update Posted: Oct 14, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	The control group will receive only standardized education.
Period Title: Overall Study
STARTED	125	127
COMPLETED	125	127
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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.	The control group will receive only standardized education.	Total of all reporting groups
Overall Participants	125	127	252
Age (Count of Participants)
<=18 years	125 100%	127 100%	252 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	9.3 (3.2)	9.2 (3.5)	9.2 (3.3)
Sex: Female, Male (Count of Participants)
Female	44 35.2%	39 30.7%	83 32.9%
Male	70 56%	86 67.7%	156 61.9%
Race/Ethnicity, Customized (Percentage of participants) [Number]
Non-Hispanic/White %	24.0 19.2%	23.6 18.6%	47.6 18.9%
Non-Hispanic/Black %	23.2 18.6%	33.1 26.1%	56.3 22.3%
Hispanic %	40.0 32%	28.4 22.4%	68.4 27.1%
Other Race/Ethnicity %	7.2 5.8%	7.8 6.1%	15.0 6%
No Data %	5.6 4.5%	7.1 5.6%	12.7 5%
Region of Enrollment (Count of Participants)
United States	125 100%	127 100%	252 100%
Insurance Type (Percentage of participants) [Number]
Private Insurance %	40 32%	43.3 34.1%	42.8 17%
Public Insurance %	59.2 47.4%	56.7 44.6%	57.2 22.7%
ACT Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.8 (4.5)	19.6 (3.8)	19.2 (4.2)
PACQLQ (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.7 (1.3)	5.8 (1.1)	5.8 (1.2)

Outcome Measures

1. Primary Outcome

Title	Asthma Control Test (ACT)
Description	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).
Time Frame	12 month follow-up assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	The control group will receive only standardized education.
Measure Participants	125	127
Mean (Standard Error) [units on a scale]	21.8 (.4)	19.9 (.4)

2. Primary Outcome

Title	Frequency of Urgent Health Utilization
Description	Number of Asthma-related ED visits during the 12 month study period
Time Frame	the 12 month study period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	The control group will receive only standardized education.
Measure Participants	125	127
Mean (Standard Error) [events (asthma-related ED visits)]	1.0 (.1)	.6 (.1)

3. Primary Outcome

Title	12 Month Rate of Medication Use
Description	Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
Time Frame	Over a 12 month study period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	The control group will receive only standardized education.
Measure Participants	125	127
Mean (Standard Error) [OCS Prescriptions]	1.3 (.2)	.9 (.2)

4. Secondary Outcome

Title	Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
Description	The 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.
Time Frame	12 month study follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	The control group will receive only standardized education.
Measure Participants	125	127
Mean (Standard Deviation) [units on a scale]	6.3 (1.0)	6.0 (1.4)

5. Primary Outcome

Title	Frequency of Asthma-related Hospitalizations
Description	Number of Asthma-related Hospitalizations during the 12 month study period
Time Frame	the 12 month study period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	The control group will receive only standardized education.
Measure Participants	125	127
Mean (Standard Error) [Events (Asthma-related Hospitalizations)]	.4 (.1)	.1 (.06)

Adverse Events

Time Frame	12 months
Arm/Group Title	Intervention		Control
Arm/Group Description	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.		The control group will receive only standardized education.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/127 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/127 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/125 (0%)		0/127 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.