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

NCT06223217 | Recruiting DMC

• 1 other identifier: VQL Study
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Ankle brachial index（ABI）

  pre-operation；6-month；12-month

• EQ-5D-5L Scale

  pre-operation；1-month；3-month；6-month；12-month

Study Arms (1)

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.

Other: Surveys and Questionnaires

Interventions

Surveys and Questionnaires OTHER

The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale

Experiment group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient is diagnosed with lower extremity peripheral arterial disease and no restrictions on Rutherford grading, TASC grading, GLASS grading.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead
• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• First People's Hospital of Hangzhou: collaborator
• Huashan Hospital: collaborator
• Hospital of Chengdu University of TCM: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jingpu Zhu

CONTACT

+86-17520505530; a8600809@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: October 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CN (1)