Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- the Modified version of VascuQol Scale
研究概览
简要总结
The purpose of this study is to assess the utility of the Modified version of VascuQol Scale as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.
详细描述
In the prior study, the original 25-item VascuQol Scale demonstrates the limitation of dimensional mixing. As a result, we suggest improving the original scale by integrating the five dimensions and simplifying the objects. 480 patients will be recruited to complete the Chinese version of VascuQol Scale and the modified version. Reliability, validity, responsiveness, and diagnostic accuracy for CLTI will be used to evaluate whether the modified scale could serve as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.
Study Procedures :
After signing the informed consent form, eligible patients and/or their legal guardians will complete the questionnaires.
Outcome measures:
Patient-Reported Outcomes via specific questionnaires
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-90
- •The patient is diagnosed with lower extremity peripheral arterial disease
- •The patient is willing to comply with specified follow-up evaluations at the specified times
- •The patient understands the nature of the procedure and provides written informed consent before enrolment in the study
- •Before enrolment, the guidewire has crossed the target lesion
- •No restrictions on Rutherford grading, TASC grading, GLASS grading
排除标准
- •Pregnant women or Female patients with potential childbearing
- •The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
- •Patients unwilling or refusing to sign informed consent
- •Patients with other diseases that may seriously affect the quality of life, such as tumors, severe liver disease, cardiac insufficiency, etc., or those with a life expectancy of less than 2 years
结局指标
主要结局
the Modified version of VascuQol Scale
时间窗: pre-operation；1-month；3-month；6-month；12-month
It is one of the frequently used scales to measure quality of life in patients with lower extremity arterial disease. It evaluates 5 different categories such as the symptom, social, activity, pain and emotional with a total of 25 sub-items. A 7-point Likert system is used to score this scale. It is sufficient for each item to check the corresponding boxes. In Modified version，we adjusted the questionnaire items and structure based on the the Chinese version and results of the previous reserach.
the Chinese version of VascuQol Scale
时间窗: pre-operation；1-month；3-month；6-month；12-month
It is one of the frequently used scales to measure quality of life in patients with lower extremity arterial disease. It evaluates 5 different categories such as the symptom, social, activity, pain and emotional with a total of 25 sub-items. A 7-point Likert system is used to score this scale. It is sufficient for each item to check the corresponding boxes. In Chinese version，not only did we complete cultural adaptation, but we used the emoji-based visual analogue scale to help patients fill out the scales.
次要结局
- Ankle brachial index（ABI）(pre-operation；6-month；12-month)
- EQ-5D-5L Scale(pre-operation；1-month；3-month；6-month；12-month)