Enhanced Community-Based Asthma Monitoring Through Novel Technology (EMT)

Nemours Children's Health

Status: Completed

Conditions: Asthma in Children

Treatments: Behavioral: Pilot study arm for technology-enhanced asthma intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05824936

2002602

P20GM144270 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this pilot interventional study is to learn about the implementation of a home monitoring program (using remote study visits and lung function testing) in children with asthma.

The main questions to answer are:

1. Do participants find the program to be feasible, acceptable and accessible?
2. What factors are associated with completion of the program?
3. Does the program have an effect on asthma control and daytime sleepiness?

Full description

The primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically underserved children with persistent asthma in Delaware and to determine its feasibility, acceptability, and accessibility.

Additionally, the proposed study aims to explore patient and family demographic characteristics and social factors associated with successful completion of the program and to explore the preliminary effect of the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime functioning.

Enrollment: 15 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Followed by a Primary Care Practice meeting HRSA rural or medically underserved designation status
• Diagnosis of persistent asthma: on at least 1 controller/ preventative medication for asthma
• Ability to follow directions and perform study measures, including in-office spirometry at initial visit
• Access to mobile device with internet connectivity to connect to telehealth visit and mobile spirometer application

Exclusion criteria

• Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital heart disease)
• Non-English Speaking

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Pilot study arm for technology-enhanced asthma intervention

Experimental group

Description:

All participants will be in the pilot arm for technology-enhanced intervention program.

Treatment:

Behavioral: Pilot study arm for technology-enhanced asthma intervention