Enhanced Community-Based Asthma Monitoring Through Novel Technology

Not Applicable

Completed

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

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 feasibile, 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pilot study arm for technology-enhanced asthma intervention	Pilot study arm for technology-enhanced asthma intervention	All participants will be in the pilot arm for technology-enhanced intervention program.

Primary Outcome Measures

Name	Time	Method
Feasibility (Retention %)	24 weeks	The primary outcome of feasibility will be evaluated by calculating retention rates at each study time point.
Acceptability	24 weeks	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.
Accessibility	24 weeks	The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
Feasibility (Completion of study measures including generation of mobile spirometry results)	24 weeks	The percentage (%) of participants who are successful at completing all study measures, including generation of mobile study results at each study time point will be calculated.

Secondary Outcome Measures

Name	Time	Method
Explore patient and family-related demographic characteristics and psychosocial factors associated with successful completion of the intervention.	24 weeks	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 factors associated with study completion at item-level.
Explore the preliminary effectiveness of the pilot program on asthma control.	24 weeks	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.
Explore asthma-related factors associated with successful completion of the intervention.	24 weeks	The study-specific asthma history questionnaire will be completed at study visits. Descriptive and comparative statistics will be employed to characterize participant-specific asthma factors associated with study completion at item-level.
Explore the preliminary effectiveness of the pilot program on daytime sleepiness.	24 weeks	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).

Locations (1): Nemours Children's Health
🇺🇸
Wilmington, Delaware, United States