跳至主要内容
临床试验/NCT06231030
NCT06231030招募中不适用

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

Nigde Omer Halisdemir University3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
3
主要终点
Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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 .

Neurologic Fatigue Inventory-Multiple Sclerosis (NYI-MS)

时间窗: 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.

General Self-Efficacy Scale

时间窗: 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.

Multiple Sclerosis Quality of Life-MuSiQoL

时间窗: 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).

次要结局

  • Mini Mental State Examination (MMSE)(Baseline)
  • Expanded Disability Status Scale (EDSS)(Baseline)
  • Interview Form(Baseline)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asli Celik

Lecturer, PT. MSc.

Nigde Omer Halisdemir University

研究点 (3)

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