Association Between Activity and PROMIS Pediatric Measures in Children With Asthma

Completed

Conditions studied: Pediatric Asthma

In brief

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.

Key facts

Study ID: NCT03933540
Run by: Duke University
People needed: 105
Starts: 2018-11-15
Expected to finish: 2019-08-30
Last updated by the study team: 2019-09-10

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 8 to < 18 years
Patient meets one of the following criteria at the time of screening:
FEV1 (Forced expiratory volume) less than 80% predicted, or
One or more exacerbations requiring systemic steroids in the last year, or
Partly controlled or uncontrolled asthma, using the GINA 2016 guidelines for asthma diagnosis and management
Ability to read and understand English.
Provide informed written assent and receive informed written consent from parent.
Ability and willingness to participate in all study activities, including completion of online surveys and wearing an activity monitor on the wrist for four weeks.
Ability and willingness to participate in a follow up visit in the clinic/and or home 26 - 30 days after the initial clinic/and or home visit.
Access to a smart phone, computer, tablet, or other device with internet access that is capable of supporting survey completion via the PRO-Core website.

You may not qualify if…

Clinically significant cognitive or memory impairment in the opinion of clinical or research staff
A child or adolescent who is under the legal custody of a state or a subdivision of the state.
Comorbid conditions that could confound results such as chronic heart disease, cystic fibrosis, VCD, etc., as determined by site investigator

Where it is running

Boston Children's Hospital — Boston, Massachusetts, United States
Univerity of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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