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

NCT ID: NCT02994238

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Remote Health Management Sensor Platform

Intervention Type: 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.

Control

The control group will receive only standardized education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Reciprocal Labs; Propeller Health Systems

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

Dr. Deneen Vojta

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Deneen Vojta

Executive Vice President, Research and Development, UnitedHealth Group

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33386336 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB 2016-698

Identifier Type: -

Identifier Source: org_study_id