Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| First People's Hospital of Hangzhou | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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
Participant numbers:
480 patients will be recruited
Data management:
Data will be collected directly from the patients. All paper patient records will be kept in locked filing cabinet. Electronic files will be saved on password protected folder
Oversight :
i) Data will be collected in a electric database; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) If it is a computerized document, it will be kept on the center's information server with access control by password.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment group | Patients who undergoing endoluminal treatment for lower extremity peripheral arterial disease will complete the Modified version of the VascuQoL scale, the Chinese version of the VascuQoL scale, EQ-5D-5L Scale and the ABI test according to follow-up plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys and Questionnaires | Other | The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Modified version of VascuQol Scale | 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. | pre-operation;1-month;3-month;6-month;12-month |
| the Chinese version of VascuQol Scale | 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. | pre-operation;1-month;3-month;6-month;12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle brachial index(ABI) | The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABPI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. | pre-operation;6-month;12-month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The patient is diagnosed with lower extremity peripheral arterial disease and no restrictions on Rutherford grading, TASC grading, GLASS grading.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingpu Zhu | Contact | +86-17520505530 | a8600809@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
| Huashan Hospital | OTHER |
| Hospital of Chengdu University of TCM | UNKNOWN |
Not provided
Not provided
Not provided
| EQ-5D-5L Scale | EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. | pre-operation;1-month;3-month;6-month;12-month |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |