NCT03662347

Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,100 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fatigue is the most common symptom and the most disabling symptom of Multiple Sclerosis, and its inefficient management can be a source of multiple consultations (increase in health costs) and a reduction in productivity (work stoppages). Hence the need to define the most effective therapeutic strategy to reduce fatigue in Multiple Sclerosis. One of the aims of this project is to provide clinical indicators that can serve as evaluation criteria for determining the most effective fatigue management strategy in Multiple Sclerosis. The primary objective of the study is to determine the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptomatic State (PASS) for fatigue in Multiple Sclerosis. The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

Detailed description

Two-year patient follow-up is planned with data collection at 0, 12 and 24 months. In addition to data already collected as part of the establishment and monitoring of the ReLSEP registry, more specific data for this study will be collected at 0, 12 and 24 months by self-questionnaires sent to patients' homes.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2020-03-19
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2018-09-07
• Last updated: 2020-07-08

Locations

1 site across 1 country: France