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

NCT06830213 | Not Yet Recruiting

• 1 other identifier: SBA 24/1114
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Familial Mediterranean Fever (FMF )

Keywords

Familial Mediterranean Fever; biopsychosocial; depression; social isolation; pain; sleep; functionality

Outcome Measures

Primary Outcomes (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

  3 mounths

Secondary Outcomes (5)

• Hospital Anxiety Depression Scale

  3 mounths

• Health Assessment Questionnaire

  3 mounths

• Short Form - 36

  3 mounths

• Pain Catastrophizing Scale

  3 mounths

• Fatigue Severity Scale

  3 mounths

Interventions

Questionnaire study OTHER

Questionnaire application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aysima Barlak: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean Fever; Depression; Social Isolation; Pain

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior; Social Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aysima Barlak, Licence

CONTACT

5412311754; fztasyimabarlak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)