Technology-enabled Patient Support System for Self-management of Pediatric Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Health-related quality of life (CFQ-R scores)
研究概览
简要总结
This project will test a technology-enabled patient support system (PSS) as a self-management tool for children with CF and their family caregivers.
详细描述
The goal of this study is to refine and test a technology-enabled patient support system (PSS) as a tool for self-management of pediatric CF. The PSS includes two components: 1) patient-facing: an app with customizable dashboards for tracking patient-generated outcome measures and providing personally relevant decision-making support; and 2) clinic-based: clinical patient management and technical support. Using a one-group pretest-posttest design, we will evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs). Study hypothesis: Among pediatric CF patients treated at the UAB CF Center, the use of technology-aided PSS over 6 months will improve health-related quality of life (primary outcome) as well as patient satisfaction, patient activation, and shared decision-making (secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Cystic Fibrosis -
排除标准
- 未提供
结局指标
主要结局
Health-related quality of life (CFQ-R scores)
时间窗: 6 months
The primary outcome is difference in CFQ-R scores between pre/post intervention. The CFQ-R consists of 9 QOL domains (physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions) and 3 symptom scales (weight, respiratory, and digestion). Items for each CFQ-R domain are summed to generate a domain score ranging from 0 to 100, with higher scores indicating better QOL.
次要结局
- Shared decision-making (CollaboRate scores)(6 months)
- Patient/caregiver satisfaction (PACIC scores)(6 months)
- Patient/caregiver activation (PAM scores)(6 months)
研究者
Gabriela R Oates
Assistant Professor, Principal Investigator
University of Alabama at Birmingham