Takayasu ArteritisNCT06979245
Turkish Adaptation of the VascuQoL-6 Quality of Life Scale
An observational study of Takayasu Arteritis and Behcet Disease, run by Uşak University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Takayasu Arteritis, Behcet Disease, Quality of Life
- How many people
- 37 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 10 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those diagnosed with Takayasu Arteritis or Vascular Behçet's disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Pamukkale University Rheumatology Clinic and Pamukkale University Faculty of Physiotherapy and Rehabilitation
Denizli, 20160
Pamukkale University
Denizli, 20160
About this study
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 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:
Read more
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.
Read the 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
- Keywords
- Takayasu arteritis, Behcet Disease, Turkish, Validity, Reliability, Quality of life
- Medical subject headings
- Takayasu Arteritis, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Quality of Life Questionnaire-6
VascuQoL aims to assess quality of life in peripheral arterial disease, regardless of disease severity (i.e. in intermittent claudication and critical limb ischemia). It consists of 6 items. Each item has a 7-point response scale (1: worst quality of life; 7: best quality of life).
Measured: At enrollment and 1 week
Secondary outcomes (5)
Takayasu Arteritis: Kerr Criteria and Indian Takayasu's Clinical Activity Score (ITAS2010)
In Takayasu arteritis, the disease extent index (DEI.TAK) was developed in TAK as a criterion that focuses on findings related to large vessel disease rather than general characteristics of the disease. In 2010, the new version of DEI.TAK, the Indian Takayasu Clinical Activity Score-ITAS2010, was created. The 5 main items belonging to the cardiovascular (CV) system, Hypertension and Stroke, are scored as 2 points each. All other items (marked only as circles) are scored as 1 point each. In addition to the 2 points due to the presence of the first 5 items in the CV section, each murmur, claudication, loss of pulse or pulse inequality is scored as 1 point each, and the total score is determined by adding these 2 points. When calculating the acute phase response ITAS (ITAS.A), first the ITAS2010 is calculated and then the acute phase response values are scored as 1-3 points within certain intervals and added to the ITAS2010 score. The definition of active disease is > 1 point for ITAS2
Measured: At enrollment
Short Form-36
It is one of the most frequently used scales to measure quality of life, consisting of 8 subcategories: physical functionality, social functionality, role limitations due to physical complaints, role limitations due to emotional problems, mental health, energy-vitality, pain, and general health perception. Separate scores are obtained for each subscale and the scores range from 0 to 100. A score of 100 indicates good health status, and a score of 0 indicates poor health status. Its Turkish validity was carried out by Koçyiğit et al. in 1999.
Measured: At enrollment
EQ-5D-3L General Quality of Life Scale
EQ-5D-3L consists of two parts: EQ-5D-3L descriptive system and EQ-5D-3L visual analog scale (EQ-5D-3L VAS). EQ-5D-3L descriptive system total score is between -0.59 and 1. "1" indicates the best health, while negative values indicate low quality of life. EQ-5D-3L VAS is scored between "0" and "100". (0: worst imaginable health status and 100: best imaginable health status)
Measured: At enrollment
Behcet's Disease Current Activity Form (BDCAF)
This index aims to evaluate all types of involvement in Behçet's disease. BDCAF is filled out by the clinician and the evaluation is made considering the day the patient comes and the last 4 weeks. The evaluation of major organ involvements such as eye, gastrointestinal system and neurological involvement should be done by experts in their field. Active findings seen in the last 4 weeks in all systems are scored and a score between 0 and 12 is obtained.It has been stated that the BDCAF score must be 2 or above for the disease to be considered active.
Measured: At enrollment
Behçet Syndrome Activity Scale
Unlike BDCAF, it is completely filled out by the patient. Similar to BDCAF, the last 4 weeks are evaluated. It is a form consisting of a total of 10 questions that can be filled out very quickly. The first 6 questions are about mucocutaneous involvement, and the other questions ask about eye, gastrointestinal and vascular involvement. Its advantage is that it also asks how much each lesion bothers the patient. However, there is no weighting according to the types of involvement in this index as in BDCAF.
Measured: At the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Mar 2025
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Kevser Gürsan, Uşak University
- Investigators
- Bilge Basakcı Calık, Prof. Dr., Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979245
- Sponsor's protocol ID
- E-60116787-020-494225
- Status last verified
- Aug 2025
- First submitted
- 11 May 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect participant confidentiality and comply with the confidentiality commitment approved by the ethics committee, no sharing of individual-level data is planned. In addition, the ethics committee decision that approved the study covers data use with limited access only. Therefore, it may not be possible to share IPD data publicly.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06979245
- Acronym / sponsor ID
- E-60116787-020-494225
- Conditions
- Takayasu Arteritis, Behcet Disease, Quality of Life
- Keywords
- Takayasu arteritis, Behcet Disease, Turkish, Validity, Reliability, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those diagnosed with Takayasu Arteritis or Vascular Behçet's disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular Quality of Life Questionnaire-6
Time frame: At enrollment and 1 week
VascuQoL aims to assess quality of life in peripheral arterial disease, regardless of disease severity (i.e. in intermittent claudication and critical limb ischemia). It consists of 6 items. Each item has a 7-point response scale (1: worst quality of life; 7: best quality of life).
5 secondary outcomes
Takayasu Arteritis: Kerr Criteria and Indian Takayasu's Clinical Activity Score (ITAS2010)
Time frame: At enrollment
Short Form-36
Time frame: At enrollment
EQ-5D-3L General Quality of Life Scale
Time frame: At enrollment
Behcet's Disease Current Activity Form (BDCAF)
Time frame: At enrollment
Behçet Syndrome Activity Scale
Time frame: At the enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No. In order to protect participant confidentiality and comply with the confidentiality commitment approved by the ethics committee, no sharing of individual-level data is planned. In addition, the ethics committee decision that approved the study covers data use with limited access only. Therefore, it may not be possible to share IPD data publicly.
Related trials for Takayasu Arteritis
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Not yet recruiting
Long-Axial Field of View (LAFOV) [18F]FDG PET/CT Imaging in Large Vessel Vasculitis (LVV): Protocol Optimisation Study.
Large Vessel Vasculitis, Takayasu Arteritis
RecruitingObservational study
Treatment of Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement
Takayasu Arteritis With Pulmonary Artery Involvement, Percutaneous Transluminal Pulmonary Angioplasty
Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy
RecruitingPhase 4
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilge Basakcı Calık, Prof. Dr. principal investigator
Pamukkale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu Arteritis and Behcet Disease, run by Uşak University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Quality of Life Questionnaire-6 (time frame: At enrollment and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.