Asthma in ChildrenEMTNCT05824936
Enhanced Community-Based Asthma Monitoring Through Novel Technology
A study testing Pilot study arm for technology-enhanced asthma intervention in people with Asthma in Children, run by Nemours Children's Clinic at 1 site in United States.
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 feasible, acceptable and accessible? 2. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Pilot study arm for technology-enhanced asthma intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital heart disease)
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Health
Wilmington, Delaware, 19803
About this study
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 feasible, acceptable and accessible?
- What factors are associated with completion of the program?
- Does the program have an effect on asthma control and daytime sleepiness?
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Pilot study arm for technology-enhanced asthma intervention
- Keywords
- asthma, spirometry, telehealth
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot study arm for technology-enhanced asthma interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot study arm for technology-enhanced asthma intervention | Experimental | All participants will be in the pilot arm for technology-enhanced intervention program. Receives: Behavioral: Pilot study arm for technology-enhanced asthma intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Retention %)
Feasibility will be evaluated by calculating retention rates at week 24.
Measured: 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.
Measured: 24 weeks
Accessibility
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
Measured: 24 weeks
Secondary outcomes (6)
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.
Measured: Baseline and Week 24
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).
Measured: Baseline and Week 24
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 demographic factors which may be associated with study completion at item-level.
Measured: 24 weeks
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)
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.
Measured: Baseline
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)
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
Measured: Baseline
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start8 Jun 2023
- Primary completion19 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Abigail Strang, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824936
- Sponsor's protocol ID
- 2002602
- Other IDs
- P20GM144270
- Acronym
- EMT
- Status last verified
- May 2025
- First submitted
- 20 Mar 2023
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Community-Based Asthma Monitoring Through Novel Technology
- ClinicalTrials.gov ID
- NCT05824936
- Acronym / sponsor ID
- EMT / 2002602
- Conditions
- Asthma in Children
- Keywords
- asthma, spirometry, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 feasible, 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma
| Arm | Type | Receives |
|---|---|---|
| Pilot study arm for technology-enhanced asthma intervention | Experimental | Behavioral: Pilot study arm for technology-enhanced asthma interventionAll participants will be in the pilot arm for technology-enhanced intervention program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital heart disease)
- Non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot study arm for technology-enhanced asthma interventionParticipants 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. | Behavioural | Pilot study arm for technology-enhanced asthma intervention |
Primary outcome
Feasibility (Retention %)
Time frame: 24 weeks
Feasibility will be evaluated by calculating retention rates at week 24.
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.
Accessibility
Time frame: 24 weeks
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
6 secondary outcomes
Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.
Time frame: Baseline and Week 24
Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.
Time frame: Baseline and Week 24
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Time frame: 24 weeks
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)
Time frame: Baseline
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)
Time frame: Baseline
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot study arm for technology-enhanced asthma intervention in people with Asthma in Children, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Retention %) (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.