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临床试验/NCT03898258
NCT03898258已完成不适用

Evaluation of the German Short-Form Qualiveen Questionnaire

Swiss Paraplegic Research, Nottwil1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
total score

研究概览

简要总结

Two questionnaires (Qualiveen full version and Qualiveen short-form (SF)), the project information and the consent form will be sent to individuals who are scheduled for an annual control at the urological out-patient clinic of the Swiss Paraplegic Centre and who fulfill the inclusion criteria. The patients will be asked to complete the two questionnaires and to bring the completed questionnaires and the signed consent form to the annual control at the Swiss Paraplegic Centre. Participants who have consented and completed the two questionnaires will receive the two questionnaires a second time 14 days later.

The primary objective of this project is to validate the German version of the SF Qualiveen questionnaire. The secondary objective is to evaluate the measurement properties of the German SF Qualiveen questionnaire in comparison with the full version.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
  • •age ≥ 18 years

排除标准

  • •no informed consent as documented by signature
  • •history of concomitant neurological or psychological illness
  • •history of cognitive impairment
  • •insufficient German language skills

结局指标

主要结局

total score

时间窗: baseline

Total score of the Qualiveen questionnaire is the arithmetic mean of the four sub-scores. The sub-scores are assessed using a five-point Likert scale (minimum score 0, maximum score 4). The total score indicates how much quality of life is affected by bladder problems. The higher the score the more quality of life is affected.

次要结局

  • bother with limitations score(baseline)
  • change in frequency of limitations score(baseline; 14 days)
  • fears score(baseline)
  • change in fears score(baseline; 14 days)
  • change in feelings score(baseline; 14 days)
  • frequency of limitations score(baseline)
  • change in bother with limitations score(baseline; 14 days)
  • feelings score(baseline)

研究者

发起方
Swiss Paraplegic Research, Nottwil
申办方类型
Network
责任方
Sponsor

研究点 (1)

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