Enhanced Community-Based Asthma Monitoring Through Novel Technology (EMT)

March 6, 2024 updated by: Nemours Children's Clinic

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Health
        • Contact:
        • Principal Investigator:
          • Abigail R Strang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (Retention %)
Time Frame: 24 weeks
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)
Time Frame: 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.
24 weeks
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.
24 weeks
Accessibility
Time Frame: 24 weeks
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.
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 factors associated with study completion at item-level.
24 weeks
Explore asthma-related factors associated with successful completion of the intervention.
Time Frame: 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.
24 weeks
Explore the preliminary effectiveness of the pilot program on asthma control.
Time Frame: 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.
24 weeks
Explore the preliminary effectiveness of the pilot program on daytime sleepiness.
Time Frame: 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).
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Actual)

February 19, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002602
  • P20GM144270 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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