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

NCT06231030 | Unknown DMC

• 1 other identifier: Gazi University-05.09.2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Sclerosis; Self Efficacy

Keywords

Multiple sclerosis; Self Efficacy; Adaptation; Validity; Reliability

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Mini Mental State Examination (MMSE)

  Baseline

• Expanded Disability Status Scale (EDSS)

  Baseline

• Interview Form

  Baseline

Study Arms (1)

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.

Other: Validity, Reliability and Adaptation

Interventions

Validity, Reliability and Adaptation 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.

Multiple Sclerosis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic or Hacettepe University Faculty of Medicine Neurology Department or who are referred to Gazi University Department of Physiotherapy and Rehabilitation will be included in this study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• Gazi University: collaborator
• Hacettepe University: collaborator

Study Sites (3)

Nigde Omer Halisdemir University

Niğde, Niğde Province, 51200, Turkey (Türkiye)

RECRUITING

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Gazi University

Ankara, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 22492132 BACKGROUND

• 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.

  PMID: 33865337 BACKGROUND

• 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.

  PMID: 7613530 BACKGROUND

• 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.

  PMID: 22587411 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• İlke KESER, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Aslı ÇELİK, MSc.

CONTACT

+90388 311 21 05; fztaslicelik@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT. MSc.

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: November 5, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)