Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS) Turkish Adaptation

NCT ID: NCT06231030

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2025-11-05

Brief Summary

Multiple Sclerosis (MS) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. Despite functional limitations and unpredictable disease course, individuals with MS are aimed to maintain different levels of independence according to the level of disability. It is aimed to develop interventions that aim to increase self-efficacy levels and participation in daily life in individuals with this diagnosis. The "Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)" is a self-efficacy scale developed specifically for individuals with MS and answered based on patient declaration. The aim of this study is to adapt the "USE-MS" scale into Turkish and to establish its validity and reliability.

Detailed Description

Multiple Sclerosis (MS) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. Despite functional limitations and unpredictable disease course, individuals with MS are aimed to maintain different levels of independence according to the level of disability. It is aimed to develop interventions that aim to increase self-efficacy levels and participation in daily life in individuals with this diagnosis. The "Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)" is a self-efficacy scale developed specifically for individuals with MS and answered based on patient declaration. The scale, which consists of 12 questions in total, includes the assessment of the extent to which patients consider themselves competent during the performance of various tasks or activities. The aim of this study is to adapt the "USE-MS" scale into Turkish and to establish its validity and reliability. The study data will be collected multicenter and will be obtained from individuals diagnosed with MS who applied to Niğde Ömer Halisdemir University Training and Research Hospital Neurology Outpatient Clinic and Hacettepe University, Faculty of Medicine, Department of Neurology and referred to Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Necessary permissions were obtained from all institutions and the scale developers. After the purpose and method of the study were explained to the participants in detail, individuals who voluntarily agreed to participate in the study will be included. The questionnaires and scales to be used in the study will be administered by face-to-face interview method 2 times in total with 2 weeks intervals. Patients' self-efficacy will be assessed with the USE-MS scale and General Self Efficacy (GSE) questionnaires, their quality of life will be assessed with the Multiple Sclerosis International Quality of Life Questionnaire (Multiple Sclerosis Quality of Life-MuSiQoL) and their fatigue will be assessed with the Neurological Fatique Inventory Multiple Sclerosis (NFI-MS). The serial approach method will be used to translate the original NFI-MS questionnaire into Turkish. In order to determine the comprehensibility of the translated text, the Turkish version of the NFI-MS will be administered to 20 individuals with MS and the parts that are not understood will be revised. Since at least 5-10 times the number of items in the questionnaire should be included for factor analysis, the final version of the questionnaire will be applied to individuals diagnosed with MS with at least 60-120 participants. Cronbach's Alpha Reliability coefficient will be used to determine the internal consistency of the questionnaire and Rasch analysis will be applied for internal construct validity analysis.

Conditions

Multiple Sclerosis; Self Efficacy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple Sclerosis Group

Method Description Study data will be collected multicenter. It will be obtained from individuals diagnosed with MS who applied to Niğde Ömer Halisdemir University Training and Research Hospital Neurology Polyclinic and Hacettepe University, Faculty of Medicine, Department of Neurology and referred to Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

Validity, Reliability and Adaptation

Intervention Type: OTHER

Expanded Disability Status Scale (EDSS) will be applied by a neurologist to determine the disability level of the individuals included in the study. In addition to the USE-MS scale, the GSE questionnaire, MuSiQoL and NFI-MS will be administered by an expert physiotherapist. The questionnaires and scales to be used in the study will be administered by face-to-face interview method twice in total with two weeks intervals. In addition to the USE-MS scale, the GSE questionnaire, MuSiQoL and NFI-MS will be applied. The questionnaires and scales to be used in the study will be administered by face-to-face interview method 2 times in total with a 2-week interval.

Interventions

Validity, Reliability and Adaptation

Expanded Disability Status Scale (EDSS) will be applied by a neurologist to determine the disability level of the individuals included in the study. In addition to the USE-MS scale, the GSE questionnaire, MuSiQoL and NFI-MS will be administered by an expert physiotherapist. The questionnaires and scales to be used in the study will be administered by face-to-face interview method twice in total with two weeks intervals. In addition to the USE-MS scale, the GSE questionnaire, MuSiQoL and NFI-MS will be applied. The questionnaires and scales to be used in the study will be administered by face-to-face interview method 2 times in total with a 2-week interval.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with MS by a neurologist,
• Understands and speaks Turkish,
• Individuals who score 18 points or above on the mini-mental status assessment (MMSA) will be included.

Exclusion Criteria

• Dementia, hearing and/or vision loss,
• Illiterate patients will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: collaborator

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Asli Celik

Lecturer, PT. MSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlke KESER, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

Nigde Omer Halisdemir University

Niğde, Niğde Province, Turkey (Türkiye)

Site Status: RECRUITING

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Gazi University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Aslı ÇELİK, MSc.

Role: CONTACT

fztaslicelik@gmail.com

+90388 311 21 05 ext. 2093

Facility Contacts

Aslı Çelik, MSc.

Role: primary

fztaslicelik@gmail.com

090388 311 21 05 ext. 2093

Meryem Aslı Tuncer, Prof. Dr.

Role: primary

akurne@hacettepe.edu.tr

+90 312 305 1809

İlke KESER, Prof. Dr

Role: primary

ilkekeser@gazi.edu.tr

090 312 216 26 51

References

Young CA, Mills RJ, Woolmore J, Hawkins CP, Tennant A. The unidimensional self-efficacy scale for MS (USE-MS): developing a patient based and patient reported outcome. Mult Scler. 2012 Sep;18(9):1326-33. doi: 10.1177/1352458512436592. Epub 2012 Apr 5.

Reference Type: BACKGROUND

PMID: 22492132 (View on PubMed)

Seebacher B, Mills RJ, Reindl M, Zamarian L, Kircher S, Brenneis C, Ehling R, Deisenhammer F. German translation, cultural adaptation and validation of the unidimensional self-efficacy scale for multiple sclerosis. BMC Neurol. 2021 Apr 17;21(1):163. doi: 10.1186/s12883-021-02183-y.

Reference Type: BACKGROUND

PMID: 33865337 (View on PubMed)

Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

Reference Type: BACKGROUND

PMID: 7613530 (View on PubMed)

Mills RJ, Pallant JF, Koufali M, Sharma A, Day S, Tennant A, Young CA. Validation of the Neurological Fatigue Index for stroke (NFI-Stroke). Health Qual Life Outcomes. 2012 May 15;10:51. doi: 10.1186/1477-7525-10-51.

Reference Type: BACKGROUND

PMID: 22587411 (View on PubMed)

Other Identifiers

Gazi University-05.09.2023

Identifier Type: -

Identifier Source: org_study_id