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NCT03734861 · ClinicalTrials.gov registry record · NA
The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
A NA study of Asthma, sponsored by Connecticut Children's Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT03734861 is a NA study of Asthma that has completed, run by Connecticut Children's Medical Center. The registered enrollment target is 75 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03734861, a NA study of Asthma, has completed, sponsored by Connecticut Children's Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change. This trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.
Conditions Studied
Interventions
- OTHER Standard of Care
- DEVICE BreatheSmart System
Study Locations (1)
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2020-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03734861
The ClinicalTrials.gov registry entry for NCT03734861 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The listed sponsor is Connecticut Children's Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT03734861 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT03734861 about?
NCT03734861 is a clinical study titled "The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.". Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to m...
What is the current status of trial NCT03734861?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2018-03-01. Estimated completion is 2020-08-31.
What conditions does trial NCT03734861 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT03734861?
The interventions under investigation include: Standard of Care (OTHER), BreatheSmart System (DEVICE).
Who is sponsoring clinical trial NCT03734861?
This trial is sponsored by Connecticut Children's Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03734861 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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