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NCT03933540 · ClinicalTrials.gov registry record
Association Between Activity and PROMIS Pediatric Measures in Children With Asthma
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 105
- Enrollment target
NCT03933540: Completed study, sponsored by Duke University.
NCT03933540 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 105 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03933540 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
Study Summary
Aim: Determine the association between activity (steps taken) and PROMIS Pediatric measures in order to explore the use of pedometry data to augment PROs in research and clinical care. The investigators will evaluate the associations between activity trackers and scores on PROMIS pediatric measures in adolescents with partially controlled or uncontrolled asthma, aged 8 through 17 years. The investigators hypothesize that daily step data will be highly correlated with and responsive when measured against PROMIS Pediatric measures of Physical Activity and Physical Function-Mobility. The Asthma (not well controlled) cohort will receive Garmin Vivofit3 activity monitors in clinic/and or home and wear them continuously for 4 weeks while completing PROMIS measures, the ecological survey, and an additional asthma control survey online (from home) via the PRO-Core data collection system at the end of each of those 4 weeks. They will return the Vivofit3 in a follow up clinic/and or home visit at the end of the 4 week period. In addition, children/adolescents will complete a spirometry test at baseline and follow up clinic/home visits. Written and verbal instructions for Vivofit3 use will be provided. Trained CRAs will communicate frequently with participants, including when the monitor is received by the participant and when the monitors need to be returned. Monitor data will be uploaded to the device user account in the Garmin Connect Mobile App by the CRA upon return of the monitor. Data from device user accounts will be imported into a UNC PRO-Core study database. Asthma participants will receive $20 at each of the two clinic/and or home visits and $10 per completed survey. Measures and Analyses: Cross-sectional analyses of daily step and PROMIS Pediatric measures will be used to test convergent validity of conceptually linked measures. Results from regression models for longitudinal data analyses of PRO measures will be benchmarked against regression results from step
Primary Outcome
Average number of steps per day within a 1 week period, derived from Garmin VivoFit 3 activity monitor data
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2019-08-30 |
What the finished NCT03933540 record still lists
NCT03933540 is an observational study that tracks outcomes without assigning an intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03933540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03933540 about?
NCT03933540 is a clinical study titled "Association Between Activity and PROMIS Pediatric Measures in Children With Asthma". Aim: Determine the association between activity (steps taken) and PROMIS Pediatric measures in order to explore the use of pedometry data to augment PROs in research and clinical care. The investigators will evaluate the associations between activity trackers and scores on PROMIS pediatric measures...
What is the current status of trial NCT03933540?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2018-11-15. Estimated completion is 2019-08-30.
Who is sponsoring clinical trial NCT03933540?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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