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

NCT02994238 | Completed Results

• 1 other identifier: IRB 2016-698
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• 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).

  12 month follow-up assessment

• Frequency of Urgent Health Utilization

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

  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

  Over a 12 month study period

• Frequency of Asthma-related Hospitalizations

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

  the 12 month study period

Secondary Outcomes (1)

• Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire

  12 month study follow-up

Study Arms (2)

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).

Device: Remote Health Management Sensor Platform

Control

NO INTERVENTION

The control group will receive only standardized education.

Interventions

Remote Health Management Sensor Platform DEVICE

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.

Also known as: Reciprocal Labs, Propeller Health Systems

Intervention

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Deneen Vojta: lead
• Northwestern University: collaborator

Related Publications (1)

• 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.

  PMID: 33386336 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Kathy Boon- Clinical Research Associate
• Organization: Northwestern University

kathy.boon@northwestern.edu

312-503-4687

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Vice President, Research and Development, UnitedHealth Group

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: October 14, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-09