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临床试验/NCT03533049
NCT03533049已完成不适用

mHealth Family Self-Management Intervention for Parents of Transplanted Children

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2018年10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
67
试验地点
2
主要终点
Improve family coping

研究概览

简要总结

This innovative research will address a gap in the literature involving the evaluation of the impact of an individualized family-centered mHealth application to enhance daily post-discharge communication following pediatric transplant. This proposal lays the foundation for future research with myFAMI (self-management intervention) at multiple pediatric transplant centers and builds the science from which to consider post discharge monitoring and decrease cost of care in other pediatric chronic illness populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
— 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients:
  • Has undergone a heart, kidney, or liver transplant being discharged home from the hospital
  • Has two eligible family members available to answer questions about the patient
  • Family members will be eligible for participation upon meeting the following inclusion criteria:
  • is English speaking (to date the instruments being used have been validated for English speaking participants only)
  • is 18 years of age or older
  • has a pediatric family member (< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital.
  • Exclusion Criteria for the family members are:
  • presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or
  • the pediatric family member has experienced a previous transplant based on self report.
  • Participants unable to speak and read English will be excluded due to the lack of resources to develop the app and communicate via FaceTime in different languages. We will recruit family members from three types of transplant populations to allow for sufficient sample in a limited time frame for this complex pediatric surgery and high-risk population.

排除标准

  • 未提供

结局指标

主要结局

Improve family coping

时间窗: 30 days

Primary family member receiving myFAMI compared to the primary family member receiving standard post-discharge care will have improved post-discharge coping (primary outcome). Coping will be measured using the post-discharge coping difficulty scale. Post Discharge Coping Difficulty Scale (PDCDS), 10-item measure, Scale 0-10, Measures parental and family member difficulty coping with stress, recovery, self-care and management, support, and confidence, α= .84

次要结局

  • Decrease healthcare resources(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stacee Lerret

Associate Professor

Medical College of Wisconsin

研究点 (2)

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