Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Surveys and Questionnaires
  The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale

Первичные конечные точки

• the Modified version of VascuQol Scale [Срок оценки: pre-operation；1-month；3-month；6-month；12-month]
• the Chinese version of VascuQol Scale [Срок оценки: pre-operation；1-month；3-month；6-month；12-month]

Вторичные конечные точки (2)

• Ankle brachial index（ABI） [Срок оценки: pre-operation；6-month；12-month]
• EQ-5D-5L Scale [Срок оценки: pre-operation；1-month；3-month；6-month；12-month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06223217 · VQL Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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