Multiple SclerosisQUALVIE-SEPNCT02880553
Disability, Perceived Social Support and Quality of Life in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in Italy.
Trial summary
The World Health Organization International Classification of Functioning, Disability and Health has shown that the environment can play a major role in patients' disability, and hence in their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 23 Aug 2016to 9 Mar 2017
- 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: Patients with all forms of multiple sclerosis
Who may be able to join
- multiples sclerosis, according to McDonald's criteria
Who cannot join
- lack of French language proficiency
- severe cognitive impairment
- severe aphasia
- substance addiction
- psychiatric troubles (except for treated major depression)
- other severe neurologic or somatic disease
- pregnant or breast feeding patient
Trial locations and contacts
1 site in 1 country.
About this study
The World Health Organization International Classification of Functioning, Disability and Health has shown that the environment can play a major role in patients' disability, and hence in their quality of life. This study considers social dimensions of quality of life, particularly family as well as social and professional networks.
- 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.
statistical association between perceived social support and quality of life
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start23 Aug 2016
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michèle MONTREUIL, PhD, Study chair, Directrice du laboratoire de psychopathologie et neuropsychologie (LPN EA 2027), Université Paris 8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880553
- Sponsor's protocol ID
- RDS_2016_11
- Acronym
- QUALVIE-SEP
- Status last verified
- Jul 2017
- First submitted
- 23 Aug 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disability, Perceived Social Support and Quality of Life in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02880553
- Acronym / sponsor ID
- QUALVIE-SEP / RDS_2016_11
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
The World Health Organization International Classification of Functioning, Disability and Health has shown that the environment can play a major role in patients' disability, and hence in their quality of life. This study considers social dimensions of quality of life, particularly family as well as social and professional networks.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with all forms of multiple sclerosis
Key inclusion criteria (1 listed)
- multiples sclerosis, according to McDonald's criteria
Key exclusion criteria (7 listed)
- lack of French language proficiency
- severe cognitive impairment
- severe aphasia
- substance addiction
- psychiatric troubles (except for treated major depression)
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
statistical association between perceived social support and quality of life
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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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.
Michèle MONTREUIL, PhD study chair
Directrice du laboratoire de psychopathologie et neuropsychologie (LPN EA 2027), Université Paris 8
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 Fondation Ophtalmologique Adolphe de Rothschild at 1 site in Italy.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jul 2017. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
statistical association between perceived social support and quality of life (time frame: immediate). 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 28 Jul 2017.