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Association Between Activity and PROMIS Pediatric Measures in Children With Asthma

NCT03933540 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2019-09-10

No results posted yet for this 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 data, to ascertain responsiveness. The investigators will use descriptive statistics to understand patterns by condition; the investigators will analyze data in aggregate and test whether disease group (covariate) is associated with outcomes. Analyses will control for demographics, mental health, and ecologic factors such as sports participation and season/weather.

Risk/Safety issues: This is a minimal risk study. Participants may be at risk for skin irritation due to continual monitor wear. Additionally, there is always a risk of breach of confidentiality associated with all research.

Conditions

  • Pediatric Asthma

Sponsors & Collaborators

Principal Investigators

  • Bryce Reeve, PhD · Duke University

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2019-08-30
Completion
2019-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933540 on ClinicalTrials.gov