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Completed

NCT Number: NCT05824936

Enhanced Community-Based Asthma Monitoring Through Novel Technology

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?

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Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Health

Wilmington, Delaware, 19803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilot study arm for technology-enhanced asthma intervention

Behavioral

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.

Primary outcomes

  1. Feasibility (Retention %)

    Time frame: 24 weeks

    Feasibility will be evaluated by calculating retention rates at week 24.

  2. Acceptability

    Time frame: 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.

  3. Accessibility

    Time frame: 24 weeks

    The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.

Secondary outcomes

  1. Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.

    Time frame: Baseline and Week 24

    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.

  2. Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.

    Time frame: Baseline and Week 24

    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).

  3. Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.

    Time frame: 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 demographic factors which may be associated with study completion at item-level.

  4. Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)

    Time frame: Baseline

    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.

  5. Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)

    Time frame: Baseline

    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

  6. Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Acronym: EMT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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