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临床试验/NCT05775679
NCT05775679招募中不适用

Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

Department of Plastic and Reconstructive Surgery1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
260
试验地点
1
主要终点
CLEFT-Q change scores

研究概览

简要总结

The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are:

  1. Are CLEFT-Q scores reliable over time?
  2. Can CLEFT-Q detect change following surgical treatment intervention?
  3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
  4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
  5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
  6. What are the main expectations that patients express before a surgical intervention?
  7. How do patients perceive that the results after surgical interventions meet their expectations?
  8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
  9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?

Participants will

  1. Fill out the questionnaire CLEFT-Q twice with a two-week space.
  2. Before and 1 year after an operation.
  3. Be interviewed about their experiences related to an operation or using CLEFT-Q.

Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.

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
8 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cleft lip and/or palate
  • Planned secondary surgery of the nose, lips, jaw or to improve speech
  • Can speak and read Swedish

排除标准

  • Multiple surgeries at once

结局指标

主要结局

CLEFT-Q change scores

时间窗: At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.

CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate

次要结局

  • Speech(Before surgery and after 1 year.)
  • Photograph(Before surgery and after 6 months or 1 year.)

研究者

发起方
Department of Plastic and Reconstructive Surgery
申办方类型
Network
责任方
Sponsor

研究点 (1)

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