NCT06223217

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 480 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
OTHER	Surveys and Questionnaires	The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

1 site across 1 country: China