Enhanced Community-Based Asthma Monitoring Through Novel Technology

Study Overview
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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: Do participants find the program to be feasibile, acceptable and accessible? What factors are associated with completion of the program? Does the program have an effect on asthma control and daytime sleepiness?

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.

Official Title
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Enhanced Community-Based Asthma Monitoring Through Novel Technology

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: Pilot study arm for technology-enhanced asthma intervention


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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot study arm for technology-enhanced asthma intervention<br>All participants will be in the pilot arm for technology-enhanced intervention program. | Behavioral: Pilot study arm for technology-enhanced asthma intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Retention %) | The primary outcome of feasibility will be evaluated by calculating retention rates at each study time point. | 24 weeks | 
| Feasibility (Completion of study measures including generation of mobile spirometry results) | 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. | 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. | 24 weeks | 
| Accessibility | The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 factors associated with study completion at item-level. | 24 weeks | 
| Explore asthma-related factors associated with successful completion of the intervention. | 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. | 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. | 24 weeks | 
| 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). | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, spirometry, telehealth