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

Multiple Sclerosis Clinical Trial

Official title:

Adaptation, Validity and Reliability of "Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)" in Turkish

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231030
• Other study ID #: Gazi University-05.09.2023
• Status: Recruiting
• Start date: November 5, 2023
• Est. completion date: November 5, 2025

Study information

• Verified date: January 2024
• Source: Nigde Omer Halisdemir University
• Contact: Asli ÇELIK, MSc.
• Phone: +90388 311 21 05
• Email: fztaslicelik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 5, 2025
• Est. primary completion date: November 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Self Efficacy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara
Turkey	Hacettepe University	Ankara
Turkey	Nigde Omer Halisdemir University	Nigde	Nigde

Sponsors (3)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University	Gazi University, Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)	It is a patient-reported self-efficacy assessment scale specific for MS patients. The original scale has been shown to be reliable and valid for self-efficacy assessment in individuals with MS. Total scoring is obtained by summing all 12 items, but items 5, 7-9 and 11 are reverse scored. USE-MS 0: Strongly disagree, 1: Disagree, 2: Undecided, 3: Agree, 4: Strongly agree on a 5-point Likert scale. The higher the score, the better the self-efficacy beliefs of individuals .	Baseline
Primary	General Self-Efficacy Scale	General Self-Efficacy Scale (GSE) has been 20 items. In 1981, it was revised and the number of items was reduced to 10. The questions in the scale are scored according to the answer given as 1: Not at all suitable for me, 2: Somewhat suitable for me, 3: Mostly suitable for me and 4: Completely suitable for me. The total score of the scale varies between 10-40 points. The higher the score, the better the self-efficacy beliefs of individuals.	Baseline
Primary	Multiple Sclerosis Quality of Life-MuSiQoL	The original version consists of 74 questions and there is also a short form consisting of 31 questions. MuSiQoL consists of a total of 9 subgroups including activities of daily living, psychological status, findings, friendships, family relationships, emotional and sexual life, acceptance, coping with the disease and satisfaction with health services. During the assessments, individuals are asked to answer by taking into account their situation in the last 4 weeks. They are asked to mark the option that best expresses themselves from the options of never (0: Never), rarely (1: Occasionally), sometimes (2: Some), frequently (3: Very) and always (4: Very much).	Baseline
Primary	Neurologic Fatigue Inventory-Multiple Sclerosis (NYI-MS)	It is a 23-item questionnaire. It has four sub-dimensions. These are physical (8 items), cognitive (4 items), recovery with diurnal sleep or rest (6 items) and abnormal nocturnal sleep and sleepiness (5 items). The questions in the questionnaire are scored as 0= Strongly disagree, 1= Disagree, 2= Agree, 3= Strongly agree. Each of the four subscales is calculated separately. However, a total scoring is not made by adding them all together. A high score indicates that the fatigue of the patients is high.	Baseline
Secondary	Mini Mental State Examination (MMSE)	MMSE will be used to evaluate cognitive functions. The mini mental test is categorized under 5 main headings. It consists of 11 items including orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). It is evaluated over 30 points in total. A score between 24-30 points is defined as normal, 18-23 points as mild dementia, and 17 points and below as severe dementia. The average administration time of the test is 10 minutes. Patients scoring 18 and above will be included in the study.	Baseline
Secondary	Expanded Disability Status Scale (EDSS)	The EDSS score varies between 0 and 10, and as the score increases, neurologic impairment and disability status increase in patients. While 0 is the result of neurologic evaluation obtained in a normal examination, 10 is considered as death due to MS. However, while the EDSS functions as an ambulation index in moderate and severe disability, it has been found to be highly inadequate in assessing cognitive or upper extremity functions.	Baseline
Secondary	Interview Form	All evaluations will be performed by face-to-face interview method. Individual characteristics of the patients (gender, age, height, body weight, marital status, education level, dominant extremity, smoking and alcohol consumption habits, use and type of assistive device, how many years they have been using the assistive device) and disease-related information (diagnosis year-duration, MS type, EDSS score, frequency of attacks, date of the most recent attack, medical history, family history, medications used, previous surgeries) will be questioned.	Baseline