NCT06979245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

May 11, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

Takayasu arteritisBehcet DiseaseTurkishValidityReliabilityQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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).

    At enrollment and 1 week

Secondary Outcomes (5)

  • Takayasu Arteritis: Kerr Criteria and Indian Takayasu's Clinical Activity Score (ITAS2010)

    At enrollment

  • Short Form-36

    At enrollment

  • EQ-5D-3L General Quality of Life Scale

    At enrollment

  • Behcet's Disease Current Activity Form (BDCAF)

    At enrollment

  • Behçet Syndrome Activity Scale

    At the enrollment

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Those diagnosed with Takayasu Arteritis or Vascular Behçet's disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Denizli, 20160, Turkey (Türkiye)

Location

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Takayasu ArteritisBehcet Syndrome

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesMouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, Genetic

Study Officials

  • Bilge Basakcı Calık, Prof. Dr.

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2025

First Posted

May 18, 2025

Study Start

March 1, 2025

Primary Completion

August 10, 2025

Study Completion

August 10, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations