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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Familial Mediterranean Fever (FMF )
• Intervention / Treatment: Other: Questionnaire study

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Aysima Barlak, Licence; Phone Number: 5412311754; Email: fztasyimabarlak@gmail.com

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey
      • Hacettepe University
      • Contact: Aysima Barlak, License; Phone Number: 05412311754; Email: fztaysimabarlak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 mounths
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.	3 mounths
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.	3 mounths
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.	3 mounths
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.	3 mounths

Collaborators and Investigators

• Sponsor: Aysima Barlak

Study record dates

Study Major Dates

• Study Start (Estimated): February 18, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pain; sleep; depression; functionality; biopsychosocial; social isolation; Familial Mediterranean Fever
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Skin Diseases, Genetic; Body Temperature Changes; Fever; Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases
• Other Study ID Numbers: SBA 24/1114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No