Clinical trial NCT05824936: Enhanced Community-Based Asthma Monitoring Through Novel Technology
Official title: Enhanced Community-Based Asthma Monitoring Through Novel Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: asthma
spirometry
telehealth
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-04-24
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma
Primary purpose: DIAGNOSTIC

Brief summary: 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?

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (Retention %)
timeFrame: 24 weeks
measure: Acceptability
timeFrame: 24 weeks
measure: Accessibility
timeFrame: 24 weeks
Secondary outcomes:
measure: Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.
timeFrame: Baseline and Week 24
measure: Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.
timeFrame: Baseline and Week 24
measure: Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
timeFrame: 24 weeks
measure: Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)
timeFrame: Baseline
measure: Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)
timeFrame: Baseline
measure: Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)
timeFrame: Baseline
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
Study officials:
References: