Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma

NCT03648450 | Completed

• 1 other identifier: Propeller Asthma Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main hypothesis of this study is to see if children and adolescents with poorly controlled asthma will find the Propeller electronic monitoring device is feasible and acceptable, and will result in improved medication adherence and asthma control. Preliminary studies indicate that Propeller can improve medication adherence rates in children with asthma and reduce the number of days of reliever medication used. It also has been shown to reduce missed days of school and hospitalizations due to asthma exacerbations. The Propeller device is a sensor that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication. It also records use of the controller and rescue inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate picture of their adherence to treatment and severity of disease. With improved adherence, asthma control should improve, resulting in a decreased costs and use of services.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Regular device use at three months

  This will be assessed by recording the number and percentage of the children and adolescents still using Propeller at three months.

  The information will be collected at three months

Secondary Outcomes (3)

• Acceptability of the Propeller EMD as determined by the electronic Medical Devices Assessment Toolkit (AMDAT)

  Data will be captured at enrollment, one month and three months after enrollment

• Asthma Control

  ACT will be assessed at enrollment, one month and three months.

• Device use at one month

  The information will be collected at one month

Study Arms (1)

Propeller Smart Inhaler EMD

All enrolled participants will be given the Propeller Smart Inhaler electronic monitoring device to use for three months to track how often they are using their inhalers either for their regular medication or as a rescue dose.

Other: Propeller EMD

Interventions

Propeller EMD OTHER

Propeller electronic monitoring device is a sensor that fits on top of inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.

Propeller Smart Inhaler EMD

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population consists of children and adolescents 10-18 years old making an ED visit or admitted to the hospital at Connecticut Children's Medical Center for an asthma exacerbation.

You may qualify if:

• Children in the ED or inpatient setting presenting with an asthma exacerbation between 10-18 years old
• History of persistent asthma (defined as prescribed a controller medication)
• Both the child and primary caregiver/parent have access to a cell phone with an activated number
• Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Child or parent has no access to a personal cell phone.
• The child has another chronic pulmonary condition (for example, cystic fibrosis)
• Having any chronic condition that could affect the child's ability to participate in the study (examples: cancer, autism, or cerebral palsy)
• The subject has an inhaler medication besides the following, given these are the current medications compatible with the Propeller EMD.
• i. Advair HFA ii. Flovent HFA iii. QVAR HFA v. Ventolin HFA vi. ProAir HFA

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

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

Study Officials

• Glenn Flores, MD

  Connecticut Children's Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 27, 2018
• Study Start: November 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)