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

NCT06587724 | Recruiting

• 1 other identifier: SBA 24/533
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myositis

Keywords

myositis; biopsychosocial model; validity and reliability; BETY-BQ; muscle strenght; pain

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

  Three months

Secondary Outcomes (12)

• Hospital Anxiety Depression Scale

  Three months

• Myositis Disease Activity Assessment Tool (MDAAT)

  Three months

• Health Assessment Questionnaire

  Three months

• Dermatology Life Quality Index

  Three months

• Hand Dynamometer

  Three months

Interventions

Questionnaire study OTHER

Questionnaire application

Also known as: BETY-Biopsychosocial Questionnaire

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:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Myositis; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Orkun Tüfekçi, PT, PhD (c)

CONTACT

5319502648; orkuntf@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, PhD(c)

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)