Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
This study will consist of two phases and will take place at Innsbruck Medical University, Clinical Department of Neurology, Austria and the Karl Landsteiner Institute for Interdisciplinary Research a
Sponsors
Medical University of Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People with any MS phenotype according to the currently valid version of the McDonald’s criteria (Thompson et al., 2018, Polman et al., 2011) at the time of diagnosis 2. Aged 18 years or over 3. Any ethnicity 4. Disability score on the Expanded Disability Status Scale (EDSS (Kurtzke, 1983)) 0 to 9.0 5. Very good German language skills
Exclusion criteria
Exclusion criteria: 1. Concomitant diseases which may affect subjective self-efficacy ratings (e.g. malignant diseases, other neurological or psychiatric disorders, depression, bipolar disorder, dementia etc) 2. Known pregnancy 3. Relapse of MS within the last two months 4. Any change of medication within the last four weeks prior to the study 5. A relapse between testings 1 and 2 during phase 2 would lead to the exclusion from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/04/2020: Phase 1 (data collected at one timepoint [baseline]): Face validity and content validity of the German 12-item Unidimensional Self-Efficacy scale for Multiple Sclerosis (USE-MS) measured by a semi-structured interview (Qualitative Content Analysis) at baseline Phase 2 (data collected at two timepoints: test 1 [T1] and test 2 [T2] 2-14 days after T1): 1. Internal consistency reliability of the German USE-MS assessed by Cronbach’s alpha at T1 and T2 2. Test-retest reliability of the German USE-MS assessed by intraclass-correlation coefficients at T1 and T2 3. Convergent validity of the German USE-MS measured by correlations with the General Self-Efficacy Scale and the short version of the Resilience Scale at T1 and T2 4. Convergent validity of the German USE-MS measured by correlations with the Multiple Sclerosis International Quality of Life questionnaire at T1 and T2 5. Divergent validity of the German USE-MS measured by correlations with the Hospital Anxiety and Depression Scale at T1 and T2 6. Divergent validity of the German USE-MS measured by correlations with the Neurological Fatigue Index at T1 and T2. These correlational analyses will be performed not before the validation of the NFI-MS using Rasch analysis has been completed. For the Rasch analysis of the NFI-MS, the same criteria will apply as for the USE-MS. Should the fatigue scale not be found sufficiently valid, the results will be deleted and changes to the study record will be made. 7. Category threshold order of the German USE-MS assessed by the Partial Credit Polytomous Model at T1 and T2 8. Local independence of the German USE-MS assessed by correlations of the item standardised residuals at T1 and T2 9. Unidimensionality of the German USE-MS evaluated by Principal Component Analysis at T1 and T2 10. Invariance across groups (gender, age, disability, disease duration, immunomodulatory drugs) , that is absence of differential item functioning of th | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 (data collected at one timepoint [baseline]): Cultural adaption of the German USE-MS for German speaking people with multiple sclerosis living in Austria, measured by a semi-structured interview (Qualitative Content Analysis) Phases 1 and 2 (data collected at baseline [phase 1] and at T1 [phase 2] by four members of the research team (three neurologists and one physiotherapist) from patients’ charts): 1. Demographic data (gender: female, male; age) 2. MS disease specific data (Expanded Disability Status Scale (EDSS) (Kurtzke, 1983) (0-4.0; 4.5-6.5; 7.0; 7.5; 8.0-9.0) 3. Disease duration 4. MS phenotype: 4.1. Relapsing-remitting 4.2. Primary progressive 4.3. Secondary progressive (Lublin and Reingold, 1996) 5. Use of disease modifying treatment (DMT): 5.1. No DMTs 5.2. Low effective DMTs: interferon-b 1a, interferon-b 1a, interferon-b 1b, pegylated interferon-b 1a, glatiramer acetate, dimethyl fumarate, teriflunomide, azathioprin, intravenous immunoglobulins 5.3. High effective DMTs: alemtuzumab, cladribine, fingolimod, natalizumab, ocrelizumab, cyclophosphamide, mitoxantrone, rituximab (Montalban et al., 2018, Diener and Weimar, 2012/2017)) Phase 2 (data collected at two timepoints: test 1 [T1] and test 2 [T2] 2-14 days after T1): 1. MS specific self-efficacy measured by the newly translated German version of the USE-MS 2. General self-efficacy measured by the validated German version (Schwarzer and Jerusalem, 1999) of the 10-item General Self-Efficacy Scale (GSE) (Schwarzer and Jerusalem, 1995) 3. Resilience measured by the validated German version (Schumacher et al., 2004) of the 13-item Resilience Scale (RS-13) (Leppert et al., 2008), which is based on the original English 25-item Resilience Scale (Wagnild and Young, 1993) 4. MS specific health-related quality of life measured by the validated German version (Flachenecker et al., 2011) of the 31-item Multiple Sclerosis International Quality of Life (MusiQol) questionnaire (Simeoni et al., 2008) 5. Anxi | — |
Countries
Austria
Contacts
Public ContactBarbara Seebacher
Outcome results
None listed