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Familial Mediterranean Fever (FMF )NCT06830213

Investigation of the Validity, Reliability and Responsiveness of the BETY-BQ in FMF

An observational study of Familial Mediterranean Fever (FMF ), run by Aysima Barlak at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

FMF is associated with many different clinical entities. The disease appears to be associated with many diseases and/or syndromes with common features of genetic predisposition, immune dysfunction and autoinflammation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Familial Mediterranean Fever (FMF )
What is being tested?
Questionnaire study
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Feb 2025to 30 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will consist of individuals who come to the university hospital for routine controls.

Who may be able to join

  • Having a diagnosis of Familial Mediterranean Fever
  • Being literate
  • Being 18 years of age or older
  • Having read and signed the informed consent

Who cannot join

  • History of major psychiatric illness
  • Malignant disease
  • History of peripheral vascular disease or neuropathy
  • Not volunteering for the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aysima Barlak, Licence contact

5412311754

fztasyimabarlak@gmail.com

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, Altındağ

    Aysima Barlak, License, 05412311754, fztaysimabarlak@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Validity, Reliability and Responsiveness of the BETY-Biopsychosocial Questionnaire in Familial Mediterranean Fever

FMF is associated with many different clinical entities. The disease appears to be associated with many diseases and/or syndromes with common features of genetic predisposition, immune dysfunction and autoinflammation. Pericardial inflammation, cardiovascular conditions such as ischaemic heart disease, other rheumatic diseases such as ankylosing spondylitis (AS), vasculitis, especially Behçet's disease, malignancy and infertility are often associated with FMF. Early detection of these associations makes it possible to improve the management and prognosis of patients with FMF.

The chronic nature of the disease, as in other chronic diseases, includes problems such as pain, fatigue, sleep problems, loss of function, anxiety, depression and social isolation. This complex structure is accompanied by a picture in which inflammatory processes are triggered.

Read more

When the literature is examined, it is emphasised that chronic diseases with multifaceted symptoms require evaluation and methods that include all these biopsychosocial features. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasised that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide an assessment from a holistic perspective in chronic diseases.

Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. The parameters that constitute the innovation are detailed under four headings: function-oriented core stabilisation exercises, information management in pain, information management in mood, and information management in sexuality. This method has a unique scale that offers biopsychosocial assessment. The Cognitive Exercise Therapy Approach - Biopsychosocial Questionnaire (BETY-BQ) was created by receiving feedback from individuals with rheumatism who participated in BETY exercise training 3 days a week for many years, expressing the improvement characteristics they experienced by participating in exercise sessions. The BETY-BQ evaluates the individual biopsychosocially with six sub-headings: pain, functionality-fatigue, emotion-state, sociability, sexuality and sleep.

The validity, reliability and sensitivity of the BETY-BQ have been demonstrated in many rheumatic diseases such as rheumatoid arthritis, fibromyalgia, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, knee osteoarthritis, primary Sjögren's syndrome. Currently, it is clear that there is a need for scales that offer biopsychosocial assessment for individuals diagnosed with rheumatism, where biopsychosocial approaches are recommended in EULAR recommendations. BETY-BQ is included in the EULAR library as a biopsychosocial status measurement tool. This study will investigate the validity, reliability and responsiveness of the BETY-BQ, a biopsychosocial assessment tool, in individuals diagnosed with Familial Mediterranean Fever.

Being tested
Questionnaire study
Keywords
Familial Mediterranean Fever, biopsychosocial, depression, social isolation, pain, sleep, functionality
Medical subject headings
Familial Mediterranean Fever, Depression, Social Isolation, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire studyOther

    Questionnaire application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BETY-Biopsychosocial Questionnaire

    The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status

    Measured: 3 mounths

Secondary outcomes (5)
  1. Hospital Anxiety Depression Scale

    It consists of 14 items, 7 of which assess anxiety, and the other 7 determine depression. Each item is scored between 0-3, and the total is scored between 0-21. High scores indicate poor anxiety and depression levels.

    Measured: 3 mounths

  2. Health Assessment Questionnaire

    The Health Assessment Questionnaire evaluates the functionality of the individual using eight parameters and 20 items. The parameters are classified as dressing, standing, eating, walking, hygiene, reaching, grasping, and other activities. Each item is scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with a lot of difficulty), and 3 (unable to do at all). The total score is between 0-3, with a high score indicating low functionality.

    Measured: 3 mounths

  3. Short Form - 36

    The SF-36 is a patient-orientated assessment scale created in the United States of America that allows for general health screening. Each sub-parameter is scored between 0 and 100 points and a high score indicates good health status. The SF-36 scale has 8 sub-parameters including general health perception, physical function, social function, pain, mental health, role difficulties due to physical causes, role difficulties due to emotional causes and vitality and includes 11 questions with a total of 36 items.

    Measured: 3 mounths

  4. Pain Catastrophizing Scale

    This scale, developed by Sullivan et al. serves to measure the extent to which individuals catastrophise pain and the exaggerated negative mental reaction they show to current or anticipated painful experience. The scale consists of 13 items. Each item is scored as never=0, slightly=1, moderately=2, greatly=3 and always=4. A high total score indicates a high degree of catastrophising of pain.

    Measured: 3 mounths

  5. Fatigue Severity Scale

    It is a scale that evaluates fatigue and consists of 9 questions. Each item is scored between 0 and 7. The total score is divided by 9, and if the average is <4, no fatigue is assessed, and if ≥4, fatigue is assessed.

    Measured: 3 mounths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start18 Feb 2025 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06830213
Sponsor's protocol ID
SBA 24/1114
Status last verified
Dec 2024
First submitted
11 Feb 2025
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Familial Mediterranean Fever (FMF ), run by Aysima Barlak at 1 site 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aysima Barlak, Licence (5412311754, fztasyimabarlak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BETY-Biopsychosocial Questionnaire (time frame: 3 mounths). 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 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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