AsthmaiTRACCNCT02994238

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

A study testing Remote Health Management Sensor Platform in people with Asthma, run by Dr. Deneen Vojta.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 4 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: Remote Health Management Sensor Platform
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: No sites listed yet
Study dates: Dec 2016to 31 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

About this study

Read the 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.

Conditions: Asthma
Being tested: Remote Health Management Sensor Platform
Medical subject headings: Asthma

What participants receive

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

Remote Health Management Sensor PlatformDevice
Also called Reciprocal Labs, Propeller Health Systems
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.

Study groups in NCT02994238
Study group	Role	What they receive
Intervention	Experimental	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). Receives: Device: Remote Health Management Sensor Platform
Control	No intervention	The control group will receive only standardized education.

What is being measured

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

Asthma Control Test (ACT)
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).
Measured: 12 month follow-up assessment
Frequency of Urgent Health Utilization
Number of Asthma-related ED visits during the 12 month study period
Measured: the 12 month study period
12 Month Rate of Medication Use
Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
Measured: Over a 12 month study period
Frequency of Asthma-related Hospitalizations
Number of Asthma-related Hospitalizations during the 12 month study period
Measured: the 12 month study period

Secondary outcomes (1)

Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
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.
Measured: 12 month study follow-up

Timeline

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

Dec 201631 Dec 2018

First posted15 Dec 2016 (estimated)
Study startDec 2016
Primary completionDec 2018
Study completion31 Dec 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
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.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02994238
Sponsor's protocol ID: IRB 2016-698
Acronym: iTRACC
Status last verified: Sep 2021
First submitted: 4 Nov 2016
Last updated: 14 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gupta RS, Fierstein JL, Boon KL, Kanaley MK, Bozen A, Kan K, Vojta D, Warren CM. Sensor-Based Electronic Monitoring for Asthma: A Randomized Controlled Trial. Pediatrics. 2021 Jan;147(1):e20201330. doi: 10.1542/peds.2020-1330.
PubMed 33386336

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
ClinicalTrials.gov ID: NCT02994238
Acronym / sponsor ID: iTRACC / IRB 2016-698
Conditions: Asthma
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Dr. Deneen VojtaIndustry (pharma, biotech, devices)
Collaborators: Northwestern University
Study start: Dec 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 15 Dec 2016 (estimated)
Results: Posted 24 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Device: Remote Health Management Sensor PlatformThe 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).
Control	No intervention	–The control group will receive only standardized education.

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Remote Health Management Sensor PlatformAlso: Reciprocal Labs, Propeller Health SystemsThe 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.	Device	Intervention

Primary outcome

Asthma Control Test (ACT)
Time frame: 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).
Frequency of Urgent Health Utilization
Time frame: the 12 month study period
Number of Asthma-related ED visits during the 12 month study period
12 Month Rate of Medication Use
Time frame: Over a 12 month study period
Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
Frequency of Asthma-related Hospitalizations
Time frame: the 12 month study period
Number of Asthma-related Hospitalizations during the 12 month study period

1 secondary outcome

Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
Time frame: 12 month study follow-up

Results and safety

Results posted to the registry on 24 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	125	125
Control	127	127

Primary outcome: Asthma Control Test (ACT)

Time frame: 12 month follow-up assessment. Mean (Standard Error). Unit: units on a scale

Measure	Intervention n = 125	Control n = 127
Value	21.8 (.4)	19.9 (.4)

Primary outcome: Frequency of Urgent Health Utilization

Time frame: the 12 month study period. Mean (Standard Error). Unit: events (asthma-related ED visits)

Measure	Intervention n = 125	Control n = 127
Value	1.0 (.1)	.6 (.1)

Primary outcome: 12 Month Rate of Medication Use

Time frame: Over a 12 month study period. Mean (Standard Error). Unit: OCS Prescriptions

Measure	Intervention n = 125	Control n = 127
Value	1.3 (.2)	.9 (.2)

Primary outcome: Frequency of Asthma-related Hospitalizations

Time frame: the 12 month study period. Mean (Standard Error). Unit: Events (Asthma-related Hospitalizations)

Measure	Intervention n = 125	Control n = 127
Value	.4 (.1)	.1 (.06)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 125 (0%)	0 of 125 (0%)	0 of 125
Control	0 of 127 (0%)	0 of 127 (0%)	0 of 127

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33386336Gupta RS, Fierstein JL, Boon KL, Kanaley MK, Bozen A, Kan K, Vojta D, Warren CM. Sensor-Based Electronic Monitoring for Asthma: A Randomized Controlled Trial. Pediatrics. 2021 Jan;147(1):e20201330. doi: 10.1542/peds.2020-1330.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
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Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Remote Health Management Sensor Platform in people with Asthma, run by Dr. Deneen Vojta.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control Test (ACT) (time frame: 12 month follow-up assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02994238, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.