Enhanced Community-Based Asthma Monitoring Through Novel Technology

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2024-03-01

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pilot study arm for technology-enhanced asthma intervention

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

Group Type EXPERIMENTAL

Pilot study arm for technology-enhanced asthma intervention

Intervention Type BEHAVIORAL

Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.

Interventions

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Pilot study arm for technology-enhanced asthma intervention

Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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