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

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ClinicalTrials.gov Identifier: NCT03662347
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease
Multiple Sclerosis

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.

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Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
Estimated Study Start Date : January 27, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Fatigue score: EMIF-SEP scale [ Time Frame: 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 :
  1. The quality of life: SF-36 [ Time Frame: changes between 0,1 and 2 years ]
    measured by SF-36 (36-Item Short Form Survey)

  2. The quality of life: MuSIQoL [ Time Frame: changes between 0,1 and 2 years ]
    measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)

  3. Nutritional behaviors (physical activity and sedentary lifestyle) [ Time Frame: changes between 0,1 and 2 years ]
    measured by GPAQ (Global Physical Activity Questionnaire)

  4. Psychological state (optimism, anxiety, depression) [ Time Frame: changes between 0,1 and 2 years ]
    measured by HAD (Hospital Anxiety and Depression scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).
Criteria

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).

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): NCT03662347


Contacts
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Contact: Jonathan EPSTEIN +33383859304 j.epstein@chru-nancy.fr
Contact: Andreia CARVALHO DE FREITAS +33383859305 A.CARVALHODEFREITAS@chru-nancy.fr

Locations
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France
CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine
Vandoeuvre Les Nancy, France, 54511
Contact: Jonathan EPSTEIN       j.epstein@chru-nancy.fr   
Principal Investigator: Jonathan EPSTEIN         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Jonathan EPSTEIN CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03662347    
Other Study ID Numbers: 2018-A00403-52
APJC2016/SeDIF_SEP-EPSTEIN/AS ( Other Identifier: sponsor code )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms