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

• Conditions: Multiple Sclerosis

• Registration Number: NCT03662347
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-07
• Status Verified: 2020-01
• Study Start: 2020-03-19
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-08
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

• Patient > or = 18 years old
• Patient with Multiple Sclerosis according to Mc Donald's diagnostic criteria
• Patient registered in the RelSEP registry
• Being able to fill out a questionnaire
• Person who has received complete information on the organization of the research and who has not objected to the exploitation of his data

Exclusion Criteria

• Patients no longer residing in Lorraine
• Bedridden patients
• Patients under guardianship, curatorship or safeguard of justice
• Patients with other serious pathologies with heavy treatments (eg cancer under chemotherapy or radiotherapy).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue score: EMIF-SEP scale	changes between 0,1 and 2 years	measured by EMIF-SEP scale (French version of the fatigue impact scale in multiple sclerosis): 40 items and 4 dimensions (physical, psychological, cognitive, social)

Secondary Outcome Measures

Name	Time	Method
Psychological state (optimism, anxiety, depression)	changes between 0,1 and 2 years	measured by HAD (Hospital Anxiety and Depression scale)
The quality of life: SF-36	changes between 0,1 and 2 years	measured by SF-36 (36-Item Short Form Survey)
Nutritional behaviors (physical activity and sedentary lifestyle)	changes between 0,1 and 2 years	measured by GPAQ (Global Physical Activity Questionnaire)
The quality of life: MuSIQoL	changes between 0,1 and 2 years	measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)

Trial Locations

Locations (1)

CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine; 🇫🇷 Vandoeuvre Les Nancy, France