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

Multiple Sclerosis Clinical Trial

— SeDiF_SEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03662347
• Other study ID #: 2018-A00403-52
• Secondary ID: APJC2016/SeDIF_S
• Status: Recruiting
• Start date: March 19, 2020
• Est. completion date: March 2022

Study information

• Verified date: January 2020
• Source: Central Hospital, Nancy, France
• Contact: Jonathan EPSTEIN
• Phone: +33383859304
• Email: j.epstein[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
France	CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue score: EMIF-SEP scale	measured by EMIF-SEP scale (French version of the fatigue impact scale in multiple sclerosis): 40 items and 4 dimensions (physical, psychological, cognitive, social)	changes between 0,1 and 2 years
Secondary	The quality of life: SF-36	measured by SF-36 (36-Item Short Form Survey)	changes between 0,1 and 2 years
Secondary	The quality of life: MuSIQoL	measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)	changes between 0,1 and 2 years
Secondary	Nutritional behaviors (physical activity and sedentary lifestyle)	measured by GPAQ (Global Physical Activity Questionnaire)	changes between 0,1 and 2 years
Secondary	Psychological state (optimism, anxiety, depression)	measured by HAD (Hospital Anxiety and Depression scale)	changes between 0,1 and 2 years