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临床试验/NCT02610946
NCT02610946Unknown不适用

Do Technology Apps Improve Compliance in Adolescent Renal Transplant Recipients?

Stanford University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Compliance

研究概览

简要总结

The purpose of this study is to empower adolescent renal transplant recipients to fully understand their medical condition as well as to help them acquire the skills to maintain a healthy allograft well into adulthood. It is hoped that introducing technological applications (apps) will assist adolescents in managing medications, clinic appointments, lab appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise frequency. The investigators aim to improve adolescent post-renal transplant outcomes (increase medication adherence, lower clinic and laboratory no-show rate, lower blood pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of allograft rejection, decrease hospitalizations) as well as reduce cost.

详细描述

The research team as well and principal investigator will identify and verify patient eligibility. Patients who are unable to speak or converse via sign language will be excluded. All participants will need to provide informed written consent.

For recruitment and informed consent, the expected benefits, risks, and uncertainties will be discussed with participants and their families. Participants will be offered enrollment in either the randomized trial or a concurrent observational cohort, which may be more feasible for families who live further away and have alternative insurance plans (Kaiser). The results of the concurrent observational cohort can be reported at a later time.

Enrollment will begin in April 2015 and end in April 2016. This is to ensure that patients who may miss an appointment can still be recruited in the following months.

Baseline variables will be collected prior to randomization including questionnaire and baseline characteristics such as age, creatinine, weight, height, BMI, urine protein-to-creatinine ratio, donor specific antibody levels, and blood pressure will be recorded. Blood draws will be done per standard of care only and blood samples will not be stored for research purposes. Computer-generated random treatment assignments will be made based on permuted blocks (randomly generated blocks of 3).

The experimental arm will have all participants attend monthly renal transplant adolescent clinic where the participant will undergo a 25-question baseline questionnaire focusing on the participant's current knowledge of own medical condition, medications, medication dosage, insurance coverage, daily fluid goal, blood pressure goal, voiding schedule, etc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent patients between 12 and 18 years of age with kidney transplants seen at Lucile Packard Children's Hospital for their transplant care at least every 3 months.

排除标准

  • Non-English speaking,
  • significant cognitive delays,
  • seen in clinic less often than every 3 months.

结局指标

主要结局

Compliance

时间窗: 1 year

Ability to adhere to medical recommendations of transplant care assessed by presence or absence of antibody-mediated rejection based on donor-specific antibody levels.

次要结局

  • Readiness to transition(1 year)

研究者

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

Ha Tran

Principle Investigator

Stanford University

研究点 (2)

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