Clinical trial NCT02980640: Swiss Multiple Sclerosis Registry
Official title: Swiss Multiple Sclerosis Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Treatment
Quality of Life
Symptoms
Lead sponsor: Swiss Multiple Sclerosis Registry
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Schweizerische Multiple Sklerose Gesellschaft
First posted: 2016-12-02
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All persons with Multiple Sclerosis who either live in Switzerland or who recieve MS care in Switzerland

Brief summary: The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of persons living with MS in Switzerland.

Detailed description: The Swiss Multiple Sclerosis Registry is a national, patient-centered research project with the aim to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of persons living with MS in Switzerland. The Swiss MS Registry pursues a "Citizen Science" approach, that is, persons with MS are not just study participants but also act as MS experts and are active contributors to the interdisciplinary Swiss MS Registry research network. Initiated and funded by the Swiss MS Society, the Swiss MS Registry represents a collaborative effort by numerous MS caregivers, researchers and persons with MS. It is hosted by the Epidemiology, Biostatistics and Prevention Institute at the University of Zurich.

How many MS-affected persons are living in Switzerland and how are they coping with MS in their daily lives? What is the current situation with regard to access to and use of drug and non-drug treatments for MS? These and other questions are addressed by means of semi-annual surveys. Further research activities concern the quality of life of persons with MS, mobility, personal resources and support by friends and family, work situation, mental health, clinical progression of MS, as well as alternative therapies.

Owing to a flexible study design, participants can decide between different levels of commitment (from one-time surveys to repeated, semiannual surveys and medical records review). Furthermore, study participants receive summaries of their data as charts and tables. Data collection primarily occurs via a newly designed online platform, but paper-and-pencil questionnaires are also available. As an additional incentive, the online platform includes a diary with basic capabilities for analyses and printing.

Eligibility criteria: Inclusion Criteria:

* Persons with a confirmed Multiple Sclerosis Diagnosis
* 18 years and older
* Living in Switzerland or receiving MS care in Switzerland

Exclusion Criteria:

* Younger than 18 years
* Not living in Switzerland and not receiving MS care in Switzerland

Primary outcomes:
measure: Change in Health-Related Quality of Life
timeFrame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Change in Self-Assessment of Health Status
timeFrame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Secondary outcomes:
measure: Occurrence of MS Symptoms
timeFrame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Occurrence of Adverse Drug Effects
timeFrame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Occurrence of MS Relapse
timeFrame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich; Epidemiology, Biostatistics & Prevention Institute
Study officials:
affiliation: University of Zurich
name: Milo Puhan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamm CP, Barin L, Gobbi C, Pot C, Calabrese P, Salmen A, Achtnichts L, Kesselring J, Puhan MA, von Wyl V; Swiss Multiple Sclerosis Registry (SMSR). Factors influencing patient satisfaction with the first diagnostic consultation in multiple sclerosis: a Swiss Multiple Sclerosis Registry (SMSR) study. J Neurol. 2020 Jan;267(1):153-161. doi: 10.1007/s00415-019-09563-y. Epub 2019 Oct 8.
citation: Steinemann N, Kuhle J, Calabrese P, Kesselring J, Disanto G, Merkler D, Pot C, Ajdacic-Gross V, Rodgers S, Puhan MA, von Wyl V; Swiss Multiple Sclerosis Registry. The Swiss Multiple Sclerosis Registry (SMSR): study protocol of a participatory, nationwide registry to promote epidemiological and patient-centered MS research. BMC Neurol. 2018 Aug 13;18(1):111. doi: 10.1186/s12883-018-1118-0.