Multiple SclerosisECOPASEPNCT02592265
Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden
An observational study of Multiple Sclerosis and Physical Disability, run by Lille Catholic University.
Trial summary
The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Physical Disability, Economic Burden
- How many people
- 233 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jun 2016
- 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: At least 230 patients in secondary and tertiary centers (8) affiliated to the regional supportive care network (GSEP) in north of France.
Who may be able to join
- Participant aged 18 or more
- Confirmed MS diagnosis (McDonald 2005)
- Defined type of MS according classification of Lublin and Reingold
Who cannot join
- Subject living in an institution
- Severe cognitive dysfunction preventing to answer questionnaire
- Subject already included in other clinical study (phase 1 to 3)
About this study
Official title: Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden and Social Participation.
The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. To the investigators' knowledge, there is currently no data including intangible costs related to caregivers and calculating the overall economic cost of Multiple Sclerosis, particularly, in France.
Read the detailed description
The goal of this study is to evaluate prospectively the economic burden of Multiple Sclerosis (MS) in France by calculating direct costs (medical and non-medical) and indirect costs and by estimating consequences of MS on utility (QALY) of patients and caregivers in a societal perspective.
- Conditions
- Multiple Sclerosis, Physical Disability, Economic Burden, Social Interaction, Capability, Quality of Life
- Medical subject headings
- Multiple Sclerosis, Financial Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual average total health care cost of the Multiple Sclerosis by patient
Global cost of Multiple Sclerosis considering direct medical and non-medical costs as well as the indirect and intangible costs associated to the patient-caregiver
Measured: 1 year
Secondary outcomes (4)
Score of social participation
Correlation between the score of social participation and health care costs of the disease will be determined
Measured: 1 year
Validity of life quality measurement EQ-5D
The EQ-5D index is a generic measure of health status that provides a simple descriptive profile and a single index value that can be used in the clinical and economic evaluation of health care
Measured: 1 year
Utilities measured by the Short Form-6D (SF-6D)
The SF-6D is a utility index based on a descriptive system composed of 11 items from six dimensions of the SF-36: physical functioning, role limitations, social functioning, pain, mental functioning and vitality.
Measured: 1 year
QALY
Health related quality in life will be measured as Quality adjusted life years (QALY)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionAug 2015
- Study completionJun 2016
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Lille, Région Nord-Pas de Calais, France, La Ligue Française Contre la Sclérose en Plaques, Novartis
- Responsible party
- Sponsor
- Investigators
- Arnaud KWIATKOWSKI, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de LilleAmélie LANSIAUX, Study director, Groupement des Hôpitaux de l'Institut Catholique de LilleGroupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592265
- Sponsor's protocol ID
- RC-P0018
- Acronym
- ECOPASEP
- Status last verified
- Sep 2024
- First submitted
- 11 Oct 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden and Social Participation.
- ClinicalTrials.gov ID
- NCT02592265
- Acronym / sponsor ID
- ECOPASEP / RC-P0018
- Conditions
- Multiple Sclerosis, Physical Disability, Economic Burden, Social Interaction, Capability, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Université de Lille, Région Nord-Pas de Calais, France, La Ligue Française Contre la Sclérose en Plaques, Novartis
- Study start
- Oct 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Oct 2015 (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 objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. To the investigators' knowledge, there is currently no data including intangible costs related to caregivers and calculating the overall economic cost of Multiple Sclerosis, particularly, in France.
Detailed description
The goal of this study is to evaluate prospectively the economic burden of Multiple Sclerosis (MS) in France by calculating direct costs (medical and non-medical) and indirect costs and by estimating consequences of MS on utility (QALY) of patients and caregivers in a societal perspective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 230 patients in secondary and tertiary centers (8) affiliated to the regional supportive care network (GSEP) in north of France.
Key inclusion criteria (3 listed)
- Participant aged 18 or more
- Confirmed MS diagnosis (McDonald 2005)
- Defined type of MS according classification of Lublin and Reingold
Key exclusion criteria (3 listed)
- Subject living in an institution
- Severe cognitive dysfunction preventing to answer questionnaire
- Subject already included in other clinical study (phase 1 to 3)
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
Annual average total health care cost of the Multiple Sclerosis by patient
Time frame: 1 year
Global cost of Multiple Sclerosis considering direct medical and non-medical costs as well as the indirect and intangible costs associated to the patient-caregiver
4 secondary outcomes
Score of social participation
Time frame: 1 year
Validity of life quality measurement EQ-5D
Time frame: 1 year
Utilities measured by the Short Form-6D (SF-6D)
Time frame: 1 year
QALY
Time frame: 1 year
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 19 Sep 2024.
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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.
Arnaud KWIATKOWSKI principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
Amélie LANSIAUX study director
Groupement des Hôpitaux de l'Institut Catholique de LilleGroupement des Hôpitaux de l'Institut Catholique de Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Physical Disability, run by Lille Catholic University.
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 3 inclusion and 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Annual average total health care cost of the Multiple Sclerosis by patient (time frame: 1 year). 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 19 Sep 2024.