Turkish Adaptation of the VascuQoL-6 Quality of Life Scale

NCT ID: NCT06979245

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-08-10

Brief Summary

Study type: Observational study Primary objective: The aim of this study was to examine the validity and reliability of the Vascular Quality of Life Questionnaire-6 (VascuQoL-6) in Turkish in individuals diagnosed with Takayasu Arteritis or Vascular Behçet's disease.

The main questions it aims to answer are:

Can VascuQoL-6 measure disease-related quality of life validly and reliably? Does the scale show significant correlations with measures such as SF-36, EQ-5D-3L, BDCAF, BSAS and ITAS-2010? There is no comparison group.

Participants will be asked to:

Contribute to the translation process of the scale into Turkish, Complete all quality of life forms in the first assessment, Participate in the test-retest analysis by re-filling VascuQoL-6 one week later.

Detailed Description

Takayasu arteritis (TA) is a rare, systemic granulomatous large vessel vasculitis that primarily affects the aorta and its branches. Although all major arteries can be affected, the descending and ascending aorta, subclavian arteries, and carotid arteries are most commonly affected. Inflammation can lead to intimal proliferation and stenosis or destruction of the vascular structure and aneurysmal degeneration. TA is a disease with profound consequences on quality of life.

Behçet's disease is a multisystemic, chronic inflammatory vasculitis characterized by skin and mucosal lesions.

The vascular involvement of Behçet's disease has characteristic features. The most important difference between Behçet's disease and other vasculitides is that venous involvement is more prevalent than arterial involvement. Many different symptoms can coexist with vascular involvement, and these symptoms require different treatments. BD characterized by vascular involvement may be a cluster different from the typical clinical setting and may differ from the typical symptomatic group in terms of treatment resistance and prognosis.

It is recommended that objective outcome measures be complemented by patient-reported outcome measures. Such measures, when integrated into daily clinical practice, are useful in clinical decision making and can also provide important information about the results of different interventions. Therefore, it is widely recommended to use disease-specific health-related quality of life instruments. Because outcome measures that focus on the specific limitations experienced by patients are made sensitive to detecting significant changes in health status in response to treatment. The Vascular Quality of Life (VascuQoL) questionnaire was developed by Morgan et al in 2001 and has been translated into 7 languages.

The aim of this study was to examine the validity and reliability of the Turkish version of the Vascular Quality of Life Questionnaire-6 in patients diagnosed with Takayasu Arteritis and Vascular Behçet's disease.

Conditions

Takayasu Arteritis; Behcet Disease; Quality of Life

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Those diagnosed with Takayasu Arteritis or Vascular Behçet's disease

The study group was diagnosed with Takayasu Arteritis or Vascular Behçet's disease by a rheumatologist.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 18-65
• Being willing to participate in the study
• Being diagnosed with Takayasu Arteritis or Vascular Behçet's disease by a rheumatologist

Exclusion Criteria

• Having another disease that will affect their physical condition
• Having a cognitive disability that will prevent them from cooperating
• Being pregnant
• Having a neurological disease (hemiplegia, Parkinson's, multiple sclerosis, vertigo, epilepsy, etc.)
• Having undergone any surgery in the last year
• Having another simultaneous rheumatic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: collaborator

Uşak University

OTHER

Sponsor Role: lead

Responsible Party

Kevser Gürsan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bilge Basakcı Calık, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University Rheumatology Clinic and Pamukkale University Faculty of Physiotherapy and Rehabilitation

Denizli, , Turkey (Türkiye)

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-60116787-020-494225

Identifier Type: -

Identifier Source: org_study_id