跳至主要内容
临床试验/NCT01370746
NCT01370746已完成不适用

Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)

National Institute of Allergy and Infectious Diseases (NIAID)15 个研究点 分布在 1 个国家目标入组 502 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
502
试验地点
15
主要终点
Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients

研究概览

简要总结

In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine.

详细描述

Adhering to treatment regimens after solid organ transplantation is critical for the prevention of complications, including acute and chronic organ rejection. It is important to recognize the perceived barriers to following treatment regimens and identify ways to address these barriers early in the course of treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subject and/or guardian must be able to understand and provide informed consent/assent in English or Spanish
  • Male or female primary solid organ transplant patients 0-21 years of age
  • Recipients at least 1 month post-transplant hospital discharge

排除标准

  • Inability or unwillingness of a participant or parent/guardian to give informed consent or comply with study protocol
  • Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the questionnaires
  • Re-transplant recipient
  • Multi-organ transplant recipient

结局指标

主要结局

Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients

时间窗: 1 month post transplant

Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)

Change in perceived barriers to adherence from baseline to follow-up

时间窗: 12 months post transplant

Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (15)

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