Multiple SclerosisSeDiF_SEPNCT03662347
Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
An observational study of Multiple Sclerosis, run by Central Hospital, Nancy, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine
Vandœuvre-lès-Nancy, 54511
Jonathan EPSTEIN, j.epstein@chru-nancy.fr
Jonathan EPSTEIN
About this study
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.
Read more
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).
Read the 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
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: changes between 0,1 and 2 years
Secondary outcomes (4)
The quality of life: SF-36
measured by SF-36 (36-Item Short Form Survey)
Measured: changes between 0,1 and 2 years
The quality of life: MuSIQoL
measured by MuSIQoL (Multiple Sclerosis International Quality of Life Questionnaire)
Measured: changes between 0,1 and 2 years
Nutritional behaviors (physical activity and sedentary lifestyle)
measured by GPAQ (Global Physical Activity Questionnaire)
Measured: changes between 0,1 and 2 years
Psychological state (optimism, anxiety, depression)
measured by HAD (Hospital Anxiety and Depression scale)
Measured: changes between 0,1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start19 Mar 2020
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan EPSTEIN, Principal investigator, CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662347
- Sponsor's protocol ID
- 2018-A00403-52
- Other IDs
- APJC2016/SeDIF_SEP-EPSTEIN/AS
- Acronym
- SeDiF_SEP
- Status last verified
- Jan 2020
- First submitted
- 4 Sep 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)
- ClinicalTrials.gov ID
- NCT03662347
- Acronym / sponsor ID
- SeDiF_SEP / 2018-A00403-52
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
The quality of life: SF-36
Time frame: changes between 0,1 and 2 years
The quality of life: MuSIQoL
Time frame: changes between 0,1 and 2 years
Nutritional behaviors (physical activity and sedentary lifestyle)
Time frame: changes between 0,1 and 2 years
Psychological state (optimism, anxiety, depression)
Time frame: changes between 0,1 and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan EPSTEIN principal investigator
CIC 1433 Epidémiologie Clinique Inserm, CHRU de Nancy, Université de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan EPSTEIN (+33383859304, j.epstein@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue score: EMIF-SEP scale (time frame: changes between 0,1 and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.