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NCT03898427 · ClinicalTrials.gov registry record
Scratch Behavior Under Standard of Care
A clinical trial of Atopic Dermatitis, sponsored by Boston University.
- Completed
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT03898427: Completed study of Atopic Dermatitis, sponsored by Boston University.
NCT03898427 is a study of Atopic Dermatitis that has completed, run by Boston University. The registered enrollment target is 100 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03898427, a study of Atopic Dermatitis, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.
Primary Outcome
One GENEActiv watch will be used on each hand at a sampling rate of 100 Hz to measure movement in the x, y, and z direction. The movement will be analyzed using the algorithm described by Cole et al. to differentiate between periods of wakefulness and sleep following SOC treatments.
Conditions Studied
Interventions
- DEVICE Videography
- DEVICE Wrist Actigraphy Devices
- DEVICE Polysomnography
Study Locations (1)
Massachusetts
- Evans Biomedical Research Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-04-04 |
| Est. Completion | 2020-12-15 |
What the finished NCT03898427 record still lists
NCT03898427 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 3 interventions - of which Videography is the first listed.
NCT03898427 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03898427 about?
NCT03898427 is a clinical study titled "Scratch Behavior Under Standard of Care". Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to...
What is the current status of trial NCT03898427?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2019-04-04. Estimated completion is 2020-12-15.
What conditions does trial NCT03898427 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT03898427?
The interventions under investigation include: Videography (DEVICE), Wrist Actigraphy Devices (DEVICE), Polysomnography (DEVICE).
Who is sponsoring clinical trial NCT03898427?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03898427 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03898427's enrollment target sits among peer trials
100 85th of 150 higher than 65 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
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