Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient Quality of Life (QOL)
研究概览
简要总结
The investigators have developed a tool to facilitate self-management for children with medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages parents daily in ongoing monitoring of common, crosscutting acute symptoms, including respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain, and seizure status. The MyChildCMC app also guides parents to recognize early warning signs for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations).
Parent comments during the development of the MyChildCMC application revealed that the tool had potential in helping them manage their child's chronic conditions. This study will be the first to explore if online home monitoring using online technology is feasible, scalable, and can lead to improved CMC outcomes. This pilot trial for the MyChildCMC app was designed to determine preliminary impact by comparing outcomes (child QOL, child emergency department and hospital admissions, and parent/caregiver satisfaction with care) between the intervention and control groups. If successful, our approach will be a model for improving CMC care and reducing costs for families and children with medical complexity. Future MyChildCMC trials will integrate care coordination and a more robust alert system to help facilitate care and follow-up for patients.
详细描述
Aim: Investigators will assess the impact of the MyChildCMC app by comparing the following outcomes for the child and caregiver:
- Child Quality of Life (QOL)
- Child Emergency Department (ED) and hospital admissions
- Number of hospital days
- Parent/Caregiver satisfaction with care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with complex medical conditions* ages 1 through 20 years with their primary caregiver (primary person caring for the child) who:
- •have been seen at Primary Children's Hospital within 365 days,
- •own a smartphone or a tablet computer with Internet access, and
- •are English speaking *Physician diagnosis was used to determine CMC diagnosis
排除标准
- •Critically ill children in imminent death
- •Non-English speakers
结局指标
主要结局
Patient Quality of Life (QOL)
时间窗: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention
Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two study Groups, using the Ellzey et. al.'s QOL survey questionnaire for children with complex medical conditions, which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. The total QOL score was reported and standardized to 100 points, with scores ranging from 20 (the lowest QOL) to 100 (the highest QOL). Higher QOL scores represent a better outcome.
次要结局
- Patient Emergency Department (ED)/Hospitalization(Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention)
- Number of Hospital Days(3-month pre and 3-month post study start)
- Parent/Caregiver Satisfaction With Care(Collected once at study end (3 months))
研究者
Flory Nkoy
Research Professor
University of Utah