Enhanced Community-Based Asthma Monitoring Through Novel Technology

NCT05824936 | Completed Results DMC

• 2 other identifiers: 2002602P20GM144270
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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. 1.Do participants find the program to be feasible, acceptable and accessible?
2. 2.What factors are associated with completion of the program?
3. 3.Does the program have an effect on asthma control and daytime sleepiness?

Conditions

Asthma in Children

Keywords

asthma; spirometry; telehealth

Outcome Measures

Primary Outcomes (3)

• Feasibility (Retention %)

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

  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 Outcomes (6)

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

  Baseline and Week 24

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

  Baseline and Week 24

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

  24 weeks

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

  Baseline

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

  Baseline

Study Arms (1)

Pilot study arm for technology-enhanced asthma intervention

EXPERIMENTAL

All participants will be in the pilot arm for technology-enhanced intervention program.

Behavioral: Pilot study arm for technology-enhanced asthma intervention

Interventions

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.

Pilot study arm for technology-enhanced asthma intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Abigail Strang
• Organization: Nemours Children's Hospital

astrang@nemours.org

3026516400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI/MD

Model Details: 15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 24, 2023
• Study Start: June 8, 2023
• Primary Completion: February 19, 2024
• Study Completion: March 1, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)