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Multiple SclerosisNCT06231030

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

An observational study of Multiple Sclerosis and Self Efficacy, run by Nigde Omer Halisdemir University at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis, Self Efficacy
What is being tested?
Validity, Reliability and Adaptation
How many people
176 participants
Where
3 sitesTurkey (Türkiye)
Study dates
5 Nov 2023to 5 Nov 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites
  • Hacettepe University

    Ankara, 06100

  • Gazi University

    Ankara, 06490

  • Nigde Omer Halisdemir University

    Niğde, Niğde Province, 51200

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Validity, Reliability and Adaptation
Keywords
Multiple sclerosis, Self Efficacy, Adaptation, Validity, Reliability
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Validity, Reliability and AdaptationOther

    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.

Study groups in NCT06231030
Study groupRoleWhat they receive
Multiple Sclerosis GroupMethod 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.
Receives: Other: Validity, Reliability and Adaptation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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).

    Measured: Baseline

  4. 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.

    Measured: Baseline

Secondary outcomes (3)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start5 Nov 2023
  3. Primary completion5 Nov 2025
  4. Study completion5 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
176 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231030
Sponsor's protocol ID
Gazi University-05.09.2023
Status last verified
Oct 2026
First submitted
19 Jan 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22492132
  • 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.

    PubMed 33865337
  • 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.

    PubMed 7613530
  • 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.

    PubMed 22587411

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Self Efficacy, run by Nigde Omer Halisdemir University at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231030, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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Clinical Trial NCT06231030 | AzTrials