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?
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
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.
Nemours Children's Health
Wilmington, Delaware, United States
Feasibility (Retention %)
Feasibility will be evaluated by calculating retention rates at week 24.
Time frame: 24 weeks
Acceptability
To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond "agree" or "strongly agree" to each item will be measured.
Time frame: 24 weeks
Accessibility
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
Time frame: 24 weeks
Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.
The asthma control test (ACT) will be completed at each study visit. This measure rates asthma symptoms from 5-25 with 5 being the lowest (poorest) asthma control and 25 being the highest (optimal) asthma control.
Time frame: Baseline and Week 24
Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.
The Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) will be completed at each study visit. This measure rates sleepiness with scores of 0-24 with 0 being the lowest degree of daytime sleepiness and 24 being the highest (sleepiest).
Time frame: Baseline and Week 24
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
The study-specific demographic and psychosocial assessment tool will be completed at the baseline visit. Descriptive and comparative statistics will be employed to characterize participant-specific demographic factors which may be associated with study completion at item-level.
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Time frame: 24 weeks
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Courses of oral steroids in the prior 6 months were calculated based on participant survey results.
Time frame: Baseline
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Number of ER visits were calculated based on survey results
Time frame: Baseline
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Hospital admissions were calculated based on survey results.
Time frame: Baseline