German translation, cultural adaption and validation of the Unidimensional Self-Efficacy scale for Multiple Sclerosis and validation of the Neurological Fatigue Index for Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN14843579
• Lead Sponsor: Medical University of Innsbruck

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31434775 protocol (added 23/08/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33865337/ USE-MS results (added 19/04/2021) 2022 Results article in https://doi.org/10.1055/a-1903-4483 in German (added 13/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-02
• Study Completion: 2020-07-31
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 322

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified