Investigation of the Validity, Reliability, and Responsiveness of the BETY-BQ in Myositis
ConditionMyositis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHacettepe University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Diagnosis of myositis
To be over 18 years old
Consent of the participant
Disqualifiers
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
Trial population
The study population will consist of individuals who come to the university hospital for routine controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaire study
Other interventionQuestionnaire application
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
Three monthsSecondary outcomes
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.
Time frame
Three months2
Myositis Disease Activity Assessment Tool (MDAAT)
The Myositis Disease Activity Assessment Tool (MDAAT) is a tool that assesses the disease activity of non-muscle organ systems and muscles in patients with myositis. The MDAAT combined tool includes the Myositis Disease Activity Assessment VAS (MYOACT) and the Myositis Activities Index for Therapeutic Purposes (MITAX). MYOACT is a series of physician judgments of disease activity in various organ systems using a VAS to assess the severity of disease activity. MITAX indicates disease damage from myositis, in the physician\'s opinion. For MYOACT, each organ system receives a score of 0-10, and the six non-muscular organ systems are summed to obtain an extra-muscular score of 0-60 or a total score including the muscular system ranging from 0-60. For MITAX, each question is scored 0 = not available; 1 = improvement; 2 = same; 3 = worse; 4 = new. The organ system scores are summed to obtain a total MITAX score of 0-63 or 0-54 if the muscular system is excluded.
Time frame
Three months3
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.
Time frame
Three months4
Dermatology Life Quality Index
Ten questions assess the quality of life-related to dermatological findings. The first and second questions are about symptoms and feelings, the third and fourth questions are about daily activities, the fifth and sixth questions are about leisure time activities, the seventh question is about work and school, the eighth and ninth questions are about interpersonal relationships and the tenth question is about treatment. The items are scored as 3 (quite a lot), 2 (very much), 1 (slightly), 0 (not at all), 0 (not relevant) between 0-30. A high score indicates a decrease in quality of life.
Time frame
Three monthsSponsors and contacts
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Source ClinicalTrials.gov