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临床试验/NCT01237847
NCT01237847Unknown不适用

A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease

Rosalind Franklin University of Medicine and Science2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Adherence

研究概览

简要总结

This project will test if a phone intervention can improve the medicine-taking behavior of teens with IBD. The investigators will study teens who are taking medicine by mouth. The investigators will test if two phone calls that help teens solve problems with their IBD medicine help to increase how often teens take their medicine. The study will also see if there is any extra benefit of more sessions (four compared to two). The investigators will ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and speak English. They must also take an IBD medication by mouth and have a parent who also wants to be in the study. Teens who agree to be in the study will fill out forms at the beginning (participant week 0), middle (participant week 12), and end of the study (participant week 20). After assessment 1, they will be randomly assigned to either receive 2 phone calls or a wait list group (participant weeks 6-10). After that, they will complete a second assessment. After the second assessment, teens who got the 2 phone calls right will be re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who were in the wait list group will get two phone sessions (participant weeks 14-18). After that, there will be a final assessment (participant week 20). The investigators expect the phone intervention sessions to reduce barriers to medicine taking, improve medicine taking, and improve teen quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patient age 11-18 years
  • patient English speaking
  • patient legal guardian willing to participate
  • patient on oral IBD maintenance medication for 3 months or longer

排除标准

  • history of significant parent-reported cognitive or developmental delay

结局指标

主要结局

Adherence

时间窗: beginning at baseline - week 20

participants will use MEMS bottles to capture adherence data from participant week 0 - participant week 20. Additionally, adherence interviews and pill counts will be conducted at participant week 0, 12, and 20.

次要结局

  • Quality of Life(at baseline, week 12, and week 20)
  • Adherence barriers(at baseline, week 12, and week 20)

研究者

研究点 (2)

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