Association Between Activity and PROMIS Pediatric Measures in Children With Asthma

NCT03933540 | Completed

• 1 other identifier: Pro00100297
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Patient Reported Outcome Measures; Activity Monitors; Pedometry; PROMIS; Health Measurement

Outcome Measures

Primary Outcomes (1)

• Average daily steps

  Average number of steps per day within a 1 week period, derived from Garmin VivoFit 3 activity monitor data

  1 week average, derived for each of the 4 weeks a participant wears the activity monitor for the month of study enrollment.

Secondary Outcomes (7)

• Self-Reported Asthma Symptoms

  Weekly assessment taken at the end of each of the four study weeks.

• PROMIS Pediatric Short Form v2.0 - Asthma Impact

  7 day recall period, taken at the end of each of the four study weeks

• PROMIS Pediatric Short Form v2.0 - Anxiety

  7 day recall period, taken at the end of each of the four study weeks.

• PROMIS Pediatric Short Form v2.0 - Depressive Symptoms

  7 day recall period, taken at the end of each of the four study weeks.

• PROMIS Pediatric Short Form v2.0 - Fatigue

  7 day recall period, taken at the end of each of the four study weeks.

Study Arms (1)

Pediatric Asthma Patients

Participants are ages 8 years through 17 years and have partially controlled or uncontrolled asthma. No intervention is included in this study.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study sample (N=100) comprises 50 children between the ages of 8 and 12 and 50 children between the ages of 13 and 17 who have uncontrolled or partly-controlled asthma.

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

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator
• Boston Children's Hospital: collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Univerity of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Hernandez ML, Lucas N, Mann C, Lin L, Burbank AJ, Brown J, Sims M, Ivins S, Cunningham A, Maciag MC, Akar-Ghibril N, Bennett AV, Phipatanakul W, Reeve BB. Association of step count with PROMIS pediatric health-related quality of life measures in children and adolescents with persistent asthma. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2492-2494. doi: 10.1016/j.jaip.2021.01.046. Epub 2021 Feb 16. No abstract available.

  PMID: 33601050 DERIVED

Study Officials

• Bryce Reeve, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 1, 2019
• Study Start: November 15, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 18 months after data collection is complete. No end date.
• Access Criteria: Anyone can access the data via the Harvard Dataverse for any type of analyses.

Locations

US (2)