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Swiss Multiple Sclerosis Registry (SMSR)

This study is currently recruiting participants.
Verified November 2016 by Swiss Multiple Sclerosis Registry
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980640
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Schweizerische Multiple Sklerose Gesellschaft
Information provided by (Responsible Party):
Swiss Multiple Sclerosis Registry
  Purpose
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.

Condition
Multiple Sclerosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 25 Years
Official Title: Swiss Multiple Sclerosis Registry

Resource links provided by NLM:


Further study details as provided by Swiss Multiple Sclerosis Registry:

Primary Outcome Measures:
  • Change in Health-Related Quality of Life [ Time Frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Assessment via EQ-5D

  • Change in Self-Assessment of Health Status [ Time Frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Assessment via Visual Analogue Scale


Secondary Outcome Measures:
  • Occurrence of MS Symptoms [ Time Frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Self-report of new and recurrent MS symptoms

  • Occurrence of Adverse Drug Effects [ Time Frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Self-report of unwanted drug side effects

  • Occurrence of MS Relapse [ Time Frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Self-report of MS relapse(s)


Estimated Enrollment: 10000
Study Start Date: June 2016
Estimated Study Completion Date: June 2041
Estimated Primary Completion Date: June 2041 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All persons with Multiple Sclerosis who either live in Switzerland or who recieve MS care in Switzerland
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980640


Contacts
Contact: Milo Puhan, MD PhD ++41 (0)44 634 4610 miloalan.puhan@uzh.ch
Contact: Viktor von Wyl, PhD ++41 (0)44 634 6380 viktor.vonwyl@uzh.ch

Locations
Switzerland
University of Zurich; Epidemiology, Biostatistics & Prevention Institute Recruiting
Zurich, Switzerland, 8001
Contact: Viktor von Wyl, PhD    ++41 (0)44 634 6380    viktor.vonwyl@uzh.ch   
Contact: Milo Puhan, MD PhD    ++41 (0)44 634 4610    miloalan.puhan@uzh.ch   
Sponsors and Collaborators
Swiss Multiple Sclerosis Registry
University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Schweizerische Multiple Sklerose Gesellschaft
Investigators
Principal Investigator: Milo Puhan, MD PhD University of Zurich
  More Information

Additional Information:
Responsible Party: Swiss Multiple Sclerosis Registry
ClinicalTrials.gov Identifier: NCT02980640     History of Changes
Other Study ID Numbers: PB_2016-00894
First Submitted: November 23, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pseudonimized data are shared with other researchers upon approval of a project proposal. Guidelines describing submission and approval process are in place.

Keywords provided by Swiss Multiple Sclerosis Registry:
Multiple Sclerosis
Treatment
Quality of Life
Symptoms

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases