Clinical trial NCT06587724: Investigation of the Validity, Reliability, and Responsiveness of the BETY-BQ in Myositis
Official title: Investigation of the Validity, Reliability, and Responsiveness of the BETY-Biopsychosocial Questionnaire in Individuals Diagnosed with Myositis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myositis
Keywords: myositis
biopsychosocial model
validity and reliability
BETY-BQ
muscle strenght
pain
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals who come to the university hospital for routine controls.

Brief summary: Individuals diagnosed with myositis have skin, joint, and visceral organ involvement together with proximal muscle weakness, impaired physical function, sexual function, and quality of life also affect individuals psychosocially. Increased anxiety-depression-anxiety problems are observed in individuals, and many factors contributing to these conditions are reported. Therefore, while holistic evaluation of individuals, including these factors, gains importance, more information on how the quality of life changes during the disease is required. There is a need for tools to evaluate these characteristics in individuals disease management and treatment process.

The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed in patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of the improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically evaluates many biopsychosocial characteristics of the individual, such as pain, coping skills, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that holistically evaluate the symptoms mentioned in myositis disease. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic disease, it aimed to examine its validation in this disease group.

This study, which the investigators planned to contribute to this field, aims to investigate BETY-BQ\^s validity, reliability, and responsiveness in individuals diagnosed with myositis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of myositis
* To be over 18 years old
* Consent of the participant

Exclusion Criteria:

* Uncontrolled/other clinically significant disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.) individuals with a diagnosis,
* Pregnant individuals,
* Individuals with malignancy

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire
timeFrame: Three months
Secondary outcomes:
measure: Hospital Anxiety Depression Scale
timeFrame: Three months
measure: Myositis Disease Activity Assessment Tool (MDAAT)
timeFrame: Three months
measure: Health Assessment Questionnaire
timeFrame: Three months
measure: Dermatology Life Quality Index
timeFrame: Three months
measure: Hand Dynamometer
timeFrame: Three months
measure: Timed Up and Go Test
timeFrame: Three months
measure: 30 Seconds Sit to Stand Sest
timeFrame: Three months
measure: 10-Metre Walk Test
timeFrame: Three months
measure: Short Form-36
timeFrame: Three months
measure: Visual Analogue Scale
timeFrame: Three months
measure: Manual Muscle Test-8
timeFrame: Three months
measure: Stair Climb Test
timeFrame: Three months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: