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

January 29, 2024 updated by: Asli Celik, Nigde Omer Halisdemir University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Hacettepe University
        • Contact:
        • Sub-Investigator:
          • Meryem Aslı TUNCER, Prof. Dr.
      • Ankara, Turkey, 06490
        • Recruiting
        • Gazi University
        • Principal Investigator:
          • İlke KESER, Prof. Dr.
        • Sub-Investigator:
          • Filiz KARDİYEN, Assoc. Prof.
        • Contact:
    • Niğde
      • Nigde, Niğde, Turkey, 51200
        • Recruiting
        • Nigde Omer Halisdemir University
        • Principal Investigator:
          • Aslı ÇELİK, MSc.
        • Sub-Investigator:
          • Dilek İŞCAN, Assist. Prof
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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)
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE)
Time Frame: Baseline
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
Expanded Disability Status Scale (EDSS)
Time Frame: Baseline
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
Interview Form
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Collaborators

Hacettepe University
Gazi University

Investigators

  • Study Director: İlke KESER, Prof. Dr., Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2023

Primary Completion (Estimated)

November 5, 2025

Study Completion (Estimated)

November 5, 2025

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University-05.09.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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