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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 : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Tracking Information
First Submitted Date September 4, 2018
First Posted Date September 7, 2018
Last Update Posted Date July 8, 2020
Actual Study Start Date March 19, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2018)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 6, 2018)
  • The quality of life: SF-36 [ Time Frame: changes between 0,1 and 2 years ]
    measured by SF-36 (36-Item Short Form Survey)
  • The quality of life: MuSIQoL [ Time Frame: changes between 0,1 and 2 years ]
    measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)
  • Nutritional behaviors (physical activity and sedentary lifestyle) [ Time Frame: changes between 0,1 and 2 years ]
    measured by GPAQ (Global Physical Activity Questionnaire)
  • Psychological state (optimism, anxiety, depression) [ Time Frame: changes between 0,1 and 2 years ]
    measured by HAD (Hospital Anxiety and Depression scale)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
Official Title Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 6, 2018)
2100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jonathan EPSTEIN +33383859304 j.epstein@chru-nancy.fr
Contact: Andreia CARVALHO DE FREITAS +33383859305 A.CARVALHODEFREITAS@chru-nancy.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03662347
Other Study ID Numbers 2018-A00403-52
APJC2016/SeDIF_SEP-EPSTEIN/AS ( Other Identifier: sponsor code )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan EPSTEIN CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine
PRS Account Central Hospital, Nancy, France
Verification Date January 2020