Association Between Activity and PROMIS Pediatric Measures in Children With Asthma
Condition: Pediatric Asthma
MeSH terms: Asthma
Study type: Observational

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.
    

Detailed description: 
      Purpose of the study:

      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 knowledge gained in this study could have direct clinical benefits, such as it will allow
      us to determine the association between steps taken (pedometer data) and PROMIS Pediatric
      measures in order to explore the use of pedometry data to augment PROs in future research and
      clinical care or to serve as a proxy measure for patients who are not able to self-report due
      to limitations in language, literacy, cognition or health status. Based on prior work with
      other PRO measures 18-20, the investigators expect that increased daily and weekly step
      numbers will reflect better overall health status. Pedometry may prove to be a useful proxy
      for health status in future research studies when adolescents are too ill to self-report
      using PROMIS or other traditional PROs.

      Background and Significance:

      Patient Reported Outcome (PRO) measures provide the opportunity to more fully gauge response
      to disease and therapy, providing actionable health information to take treatment to a more
      personalized level. For PRO measures to be widely adopted for use in either clinical trials 1
      or by health care providers, there must be substantial evidence for the reliability and
      validity of the PRO measure in the specific population. One of the most essential aspects of
      the appropriateness of a PRO measure is documentation of the responsiveness of the PRO
      measure, which indicates the ability of the PRO measure to detect change over time when it is
      expected.

      The PROMIS® measures represent a robust set of questionnaires for capturing the patient's
      experience and have undergone extensive psychometric evaluation. However, PRO measures are
      subjective and depend on a variety of patient level variables, including the patient's
      cognition, literacy, language, or health status. Additionally, some situations exist in which
      children or their parents may not be able to self-report symptoms using PROs due to language
      barriers, literacy level, or disease activity (too fatigued, etc.). Objectively reported
      steps, collected via pedometer wear, may be a way to augment the data that the investigators
      get from PRO measures and to bypass some patient level variables that can affect PRO data.

      Pedometers have been shown to be suitable for assessing step activity in children age 6 years
      and up. A 7-day monitoring period using pedometers provided an accurate estimate of normal
      physical activity in children and adolescents. Prior research in children has shown
      correlations between physical activity and psychosocial indicators,4 physical health,5 and
      cognitive function6; however, there is a deficiency of knowledge related to physical activity
      in children with chronic illnesses, such as cancer, rheumatic disease, and asthma,
      association with daily steps, and impacts on health outcomes.

      A review of several small pilot studies of physical activity monitoring in adult patients
      with cancer found physical activity, particularly the number of daily "steps", varied
      considerably across phases of disease and treatment type, including healthy controls,
      surgical resection with curative intent, and palliative chemotherapy and palliative
      radiation.7 Low fitness and decreased exercise capacity have been demonstrated in children
      with cancer,8 JIA9, 10 and SLE.11 Children with moderate to severe asthma have been shown to
      get less physical activity than their healthy peers.14, 15 More specifically, children with
      asthma tend to participate in less moderate to high intensity activity16 and to take fewer
      daily steps16, though there appears to be little difference in sedentary time for children
      with asthma and healthy controls.15, 16 However, uncertainties remain regarding the
      relationships between daily activity levels, disease activity, and relevant domains including
      physical function, pain interference, fatigue, anxiety and depression.

      Design & procedures:

      This is a single arm, observational study of 100 patients with partly controlled or
      uncontrolled asthma. The primary purpose of this study is to 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 anticipate 12
      months of participant accruals.

      Subjects will participate in two clinic/and or home visits and complete electronic surveys
      from home at three time points. During the clinic/home visits on Day 0 and Day 28 (+/- 2
      days), participants will complete the GINA checklist, a medication review, a spirometry test,
      have BMI obtained, and complete the Child Asthma Control Test (if 11 years old or younger) or
      the Asthma Control Test (if 12 years or older). On Day 0, parents will also complete a
      demographics form and the child participant will recieve their Vivofit3 monitor. The Vivofit3
      will be worn 24 hours a day for 4 weeks. At Day 28, CRA's will sync the data from the
      Vivofit3 monitor to the participants study specific user account in the Garmin Connect Mobile
      app.

      In between Days 0 and 28 participants will complete three sets of electronic surveys.
      Participants will complete their first set of surveys after 7 full days of VivoFit3 wear
      (study Day 7), and every 7 days after that (Study days 14, 21, and 28) by clicking on a link
      in the survey email that will take them to the PRO-Core data collection system. They may
      complete these surveys from home or anywhere they would like where they have internet access.
      The Day 28 survey will be completed in clinic/and or home.

      The Subject 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. The
      University of North Carolina (UNC) will accrue 30 children in each age group and the Boston
      site will accrue 20 participants in each age group. Duke is the data coordinating center for
      this study and will not be recruiting patients.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Patient Reported Outcome Measures; Activity Monitors; Pedometry; PROMIS; Health Measurement