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临床试验/NCT05056493
NCT05056493已完成不适用

Caremap: A Digital Personal Health Record for Complex Care Coordination

Duke University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey

研究概览

简要总结

This study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Investigators plan to enroll up to 40 participants from Duke University for this study. The study is sponsored by Duke's Institute for Health Innovation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey

时间窗: Baseline, 3 months, 6 months

For participants who are adult patients with complex health needs, the PROMIS Global Health Survey is a 10-item patient-reported survey that gathers patient perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).

Implementation feasibility as measured by feasibility intervention measure (FIM)

时间窗: 6 months

The feasibility intervention measure is a 4 item survey using a 5-level Likert scale (1=completely disagree; 5=completely agree).

Change in parent report of their child's health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey

时间窗: Baseline, 3 months, 6 months

For participants who are parents of children with complex health needs, the PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.

Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed

时间窗: Weekly, up to 6 months

Technical feasibility will be defined as proportion of requests for transfer of patient-level data between the electronic health record (EHR) and the app that were successfully completed.

Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)

时间窗: Baseline, 6 months

The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).

次要结局

  • Changes in adoption as measured by quantitative measurement of app engagement by provider(Monthly, up to 6 months)
  • Mobile app usability as measured by the System Usability Scale (SUS)(6 months)
  • Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)(Baseline, 6 months)
  • Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver(Weekly, up to 6 months)
  • Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)(Weekly for 6 months)
  • Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters(Baseline, 6 months)
  • Changes in adoption as measured by quantitative measurement of app prescription by provider(Monthly, up to 6 months)
  • Adaptations made by families and providers during real-world use as measured by survey(Monthly, up to 6 months)
  • Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)(Baseline, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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