Validation of Electronic Version of the VascuQoL-6 Questionnaire to Assess Patient Related Outcome Measures (ePROM) After Revascularization for Lower Limb Peripheral Arterial Disease in German-speaking Part of Switzerland
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- VascuQoL-6 Score
研究概览
简要总结
Two hundred patients evaluated to undergo revascularization (elective/emergent, surgical/interventional) for lower limb PAD at the cantonal hospital of Aarau, Switzerland, will, after consenting to participate in the study, be asked to fill up both SF-36 and VascuQol-6 questionnaires while sitting in a waiting room before the procedure and during the 30 days and 1-year routine follow up. An electronic version of the questionnaires will be administered on a tablet. The primary goal is to validate the clinical use of the German electronic version of the VascuQol-6 questionnaire to assess patient-related outcomes of the performed treatment by patients with PAD.
详细描述
Lower extremity peripheral artery disease is a chronic illness that has a significant effect on the quality of life of the patients in short- as well as long-term.
Generic Instruments, such as widely used Medical Outcomes Study Short Form 36 questionnaire (SF-36) might be too insensitive to specific problems and associated comorbidities of vascular surgery patients as well as too complicated for routine use in a busy clinical setting. Therefore, the Vascular Quality of life questionnaire (VascuQoL-25) has been developed for use in the UK in 2001 at the Vascular Surgical Unit of King's College Hospital in London. To further simplify the use of the questionnaire, a lighter Version, that reduced the amount of asked questions from 25 to 6 (VascQuol-6) has been presented and found to be both valid and relevant. VascuQoL- 6 is a disease-specific questionnaire, developed to assess health-related quality of life (HRQoL) in patients with peripheral artery disease. It has been translated to 8 languages including German, and successfully validated for the use to assess in patients with peripheral artery disease in Sweden, Netherlands, Norway, Brazil and Poland.
In opinion of the investigators, a unified means to obtain relevant data concerning patient-related outcomes following treatment (endovascular or surgical) for PAD as part of existing aftercare schemes currently lacks in Switzerland. A simple tool such as VascuQoL-6 would allow collecting and objectively assessing, as well as comparing this kind of information after such procedures.
The main objective of the project is to validate the electronic version of the VascuQoL-6 for assessment of patient-related outcomes after a revascularization procedure (either surgical or interventional) for peripheral artery disease in the German-speaking part of Switzerland preoperatively, during the routine 30 days and a one-year follow-up.
Furthermore, upon the successful validation of the electronic VascuQoL-6, the investigators seek to implement the use of this easy to use, straight-forward tool in the follow-up scheme of the Swiss Vascular Registry (SwissVasc).
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
- •confirmed PAD
- •elective or emergent revascularization indicated (surgery/intervention)
- •native German speakers - no cognitive impairment
排除标准
- •not fulfilling any of the inclusion criteria
- •patients refusing to participate
结局指标
主要结局
VascuQoL-6 Score
时间窗: 1 year after revascularisation
Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions
次要结局
- Puls-plethysmography(1 year after revascularisation)
- SF-36 Score(1 year after revascularisation)
- WIfl classification(1 year after revascularisation)
- Ankle-brachial indices(1 year after revascularisation)
- Complication rates(1 year)
研究者
Andrej Isaak
Head of Vascular Surgery
Kantonsspital Aarau