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

NCT ID: NCT06587724

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire study

Questionnaire application

Intervention Type OTHER

Other Intervention Names

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BETY-Biopsychosocial Questionnaire

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Orkun Tüfekçi

Principal Investigator, PT, PhD(c)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Orkun Tüfekçi, PT, PhD (c)

Role: CONTACT

5319502648

Facility Contacts

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Orkun Tüfekçi, PT, PhD(c)

Role: primary

+90 312 305 25 25

Other Identifiers

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SBA 24/533

Identifier Type: -

Identifier Source: org_study_id

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