Feasibility, Usability, and Validation of the Woddle Smart Changing Pad for Infant Monitoring Post-Hospital Discharge: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Data sync success rate
研究概览
简要总结
This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge. The study also compares infant weight measurements obtained using the Woddle scale with those from standard clinical reference scales to assess accuracy and reliability.
详细描述
Infants discharged from the hospital or NICU, particularly those born preterm or with low birth weight, are at increased risk for feeding difficulties, growth faltering, dehydration, and unplanned readmission. Standard follow-up care relies on scheduled in-office weight checks and caregiver self-report, which may not capture early warning signs. The Woddle Smart Changing Pad integrates a precision weight scale with diaper event, feeding, and sleep tracking into a single connected platform; a paired mobile application allows caregivers to record and view infant health data, and a provider dashboard allows clinicians to remotely monitor trends. In this single-arm, 12-week pilot, caregiver-infant dyads used the device at home while participating providers monitored data via the dashboard. The study assessed caregiver adherence, caregiver and provider usability, agreement between device and clinic reference weights, and descriptive secondary outcomes including weight trajectory, healthcare utilization, and caregiver- and provider-reported experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at gestational age 23-0 to 42-0 weeks
- •Discharged from NICU or couplet/newborn care within 45 days prior to planned enrollment
- •Clinical indication for post-discharge growth or feeding follow-up, or documentation of a qualifying ICD-10/P-code (perinatal/growth-related, feeding/nutrition, growth/weight monitoring, or follow-up/well-newborn codes)
- •Twins/triplets permitted (one device shared per family)
- •INCLUSION CRITERIA (CAREGIVER)
- •Age ≥ 18 years
- •Primary language English, Spanish, or Chinese
- •Access to a smartphone compatible with the study app and home Wi-Fi/data plan
- •Willing and able to complete study tasks over 12 weeks of home monitoring
排除标准
- •Rehospitalized within 7 days prior to planned enrollment
- •Conditions making participation inappropriate or unsafe in the opinion of the treating clinician or investigator
- •Enrolled in another interventional study that conflicts with device monitoring or study endpoints
- •EXCLUSION CRITERIA (CAREGIVER)
- •Declines or is unable to provide informed consent
- •Unable or unwilling to operate the device/app after training and reasonable technical support
- •Unwilling to allow collection of study data or provider/staff access to relevant clinical event data
结局指标
主要结局
Data sync success rate
时间窗: 12 weeks.
Proportion of expected device-to-dashboard data syncs successfully received
Caregiver adherence
时间窗: 12 weeks.
Proportion of study days (of 84) with valid device use.
Agreement between device and clinic reference weight
时间窗: Baseline, Week 6, and Week 12.
Mean bias, Bland-Altman limits of agreement, and intraclass correlation coefficient (ICC) between paired device and clinic scale weights.
Caregiver System Usability Scale (SUS) score
时间窗: Week 6 and Week 12.
10-item, 5-point Likert usability scale (range 0-100).
次要结局
- Infant weight gain trajectory(12 weeks)
- Nadir weight(12 weeks)
- Healthcare utilization(12 weeks.)
- Caregiver confidence and stress(Baseline vs. Week 12.)
- Provider usability and satisfaction(Week 12.)
- Provider actions triggered by remote data(12 weeks.)
研究者
Stan Kachnowski
Chair of the Healthcare Innovation Technology Laboratory
Healthcare Innovation Technology Lab