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

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilot study arm for technology-enhanced asthma intervention
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma in Children focused on measuring asthma, spirometry, telehealth

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemours Children's HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot study arm for technology-enhanced asthma intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility (Retention %)
The primary outcome of feasibility will be evaluated by calculating retention rates at each study time point.
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.
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.
Accessibility
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
March 20, 2023
Last Updated
June 12, 2023
Sponsor
Nemours Children's Clinic
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05824936
Brief Title
Enhanced Community-Based Asthma Monitoring Through Novel Technology
Acronym
EMT
Official Title
Enhanced Community-Based Asthma Monitoring Through Novel Technology
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
asthma, spirometry, telehealth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot study arm for technology-enhanced asthma intervention
Arm Type
Experimental
Arm Description
All participants will be in the pilot arm for technology-enhanced intervention program.
Intervention Type
Behavioral
Intervention Name(s)
Pilot study arm for technology-enhanced asthma intervention
Intervention Description
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 Outcome Measure Information:
Title
Feasibility (Retention %)
Description
The primary outcome of feasibility will be evaluated by calculating retention rates at each study time point.
Time Frame
24 weeks
Title
Feasibility (Completion of study measures including generation of mobile spirometry results)
Description
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.
Time Frame
24 weeks
Title
Acceptability
Description
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.
Time Frame
24 weeks
Title
Accessibility
Description
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Explore patient and family-related demographic characteristics and psychosocial factors associated with successful completion of the intervention.
Description
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.
Time Frame
24 weeks
Title
Explore asthma-related factors associated with successful completion of the intervention.
Description
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.
Time Frame
24 weeks
Title
Explore the preliminary effectiveness of the pilot program on asthma control.
Description
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.
Time Frame
24 weeks
Title
Explore the preliminary effectiveness of the pilot program on daytime sleepiness.
Description
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).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail R Strang, MD
Phone
302-651-6400
Email
astrang@nemours.org
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Chidekel, MD
Phone
302-651-6400
Email
achidek@nemours.org
Facility Information:
Facility Name
Nemours Children's Health
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Strang, MD
Email
astrang@nemours.org
First Name & Middle Initial & Last Name & Degree
Abigail R Strang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Community-Based Asthma Monitoring Through Novel Technology

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