An observational study in Peripheral Arterial Disease, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by RenJi Hospital · Observational
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 480 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient is diagnosed with lower extremity peripheral arterial disease and no restrictions on Rutherford grading, TASC grading, GLASS grading.
Exclusion Criteria:
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.
Other: Surveys and Questionnaires
The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale
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.
Time frame: 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.
Time frame: pre-operation；1-month；3-month；6-month；12-month
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.
Time frame: pre-operation；6-month；12-month
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.
Time frame: pre-operation；1-month；3-month；6-month；12-month
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