Evaluating the Association Between Activity and PROMIS Pediatric Measures in Children With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Average daily steps
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Average daily steps
时间窗: 1 week average, derived for each of the 4 weeks a participant wears the activity monitor for the month of study enrollment.
Average number of steps per day within a 1 week period, derived from Garmin VivoFit 3 activity monitor data
次要结局
- 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 - Fatigue(7 day recall period, taken at the end of each of the four study weeks.)
- Self-Reported Asthma Symptoms(Weekly assessment 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 - Mobility(7 day recall period, taken at the end of each of the four study weeks.)
- PROMIS Pediatric Short Form v2.0 - Peer Relationships(7 day recall period, taken at the end of each of the four study weeks.)