Clinical trial NCT06979245: Turkish Adaptation of the VascuQoL-6 Quality of Life Scale
Official title: Validity and Reliability in Turkish of Vascular Quality of Life Questionnaire-6 in Patients Diagnosed With Takayasu Arteritis and Vascular Behçet's Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Takayasu Arteritis
Behcet Disease
Quality of Life
Keywords: Takayasu arteritis
Behcet Disease
Turkish
Validity
Reliability
Quality of life
Lead sponsor: Uşak University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2025-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those diagnosed with Takayasu Arteritis or Vascular Behçet's disease

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.

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

Primary outcomes:
measure: Vascular Quality of Life Questionnaire-6
timeFrame: At enrollment and 1 week
Secondary outcomes:
measure: Takayasu Arteritis: Kerr Criteria and Indian Takayasu's Clinical Activity Score (ITAS2010)
timeFrame: At enrollment
measure: Short Form-36
timeFrame: At enrollment
measure: EQ-5D-3L General Quality of Life Scale
timeFrame: At enrollment
measure: Behcet's Disease Current Activity Form (BDCAF)
timeFrame: At enrollment
measure: Behçet Syndrome Activity Scale
timeFrame: At the enrollment
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Rheumatology Clinic and Pamukkale University Faculty of Physiotherapy and Rehabilitation
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Bilge Basakcı Calık, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: