- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06223217
Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jingpu Zhu
- Phone Number: +86-17520505530
- Email: a8600809@163.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China
- Recruiting
- RenJi Hospital
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Contact:
- Jingpu Zhu
- Phone Number: +86-17520505530
- Email: a8600809@163.com
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Principal Investigator:
- Lan Zhang, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Modified version of VascuQol Scale
Time Frame: 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.
|
pre-operation;1-month;3-month;6-month;12-month
|
the Chinese version of VascuQol Scale
Time Frame: 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.
|
pre-operation;1-month;3-month;6-month;12-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle brachial index(ABI)
Time Frame: pre-operation;6-month;12-month
|
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.
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pre-operation;6-month;12-month
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EQ-5D-5L Scale
Time Frame: pre-operation;1-month;3-month;6-month;12-month
|
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
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VQL Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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