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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote Health Management Sensor Platform
Sponsored by
Dr. Deneen Vojta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm 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).

    The control group will receive only standardized education.

    Outcomes

    Primary Outcome Measures

    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).
    Frequency of Urgent Health Utilization
    Number of Asthma-related ED visits during 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
    Frequency of Asthma-related Hospitalizations
    Number of Asthma-related Hospitalizations during the 12 month study period

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 4, 2016
    Last Updated
    September 20, 2021
    Sponsor
    Dr. Deneen Vojta
    Collaborators
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02994238
    Brief Title
    iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
    Acronym
    iTRACC
    Official Title
    iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. Deneen Vojta
    Collaborators
    Northwestern University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    252 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group will receive only standardized education.
    Intervention Type
    Device
    Intervention Name(s)
    Remote Health Management Sensor Platform
    Other Intervention Name(s)
    Reciprocal Labs, Propeller Health Systems
    Intervention Description
    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.
    Primary Outcome Measure Information:
    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
    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
    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
    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
    Secondary Outcome Measure Information:
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33386336
    Citation
    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. Erratum In: Pediatrics. 2021 Mar 31;:
    Results Reference
    derived

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

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