Enhanced Community-Based Asthma Monitoring Through Novel Technology

Asthma in Children Clinical Trial

— EMT  

Official title:

Enhanced Community-Based Asthma Monitoring Through Novel Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824936
• Other study ID #: 2002602
• Secondary ID: P20GM144270
• Status: Completed
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Nemours Children's Health	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (Retention %)	The primary outcome of feasibility will be evaluated by calculating retention rates at each study time point.	24 weeks
Primary	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
Primary	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
Primary	Accessibility	The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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