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:
- Are CLEFT-Q scores reliable over time?
- Can CLEFT-Q detect change following surgical treatment intervention?
- What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
- What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
- Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
- What are the main expectations that patients express before a surgical intervention?
- How do patients perceive that the results after surgical interventions meet their expectations?
- Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
- How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?
Participants will
- Fill out the questionnaire CLEFT-Q twice with a two-week space.
- Before and 1 year after an operation.
- 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
- 是
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
研究点 (1)
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