Plain English Summary
Background and study aims
The HORIZON 2020 (H2020) Optogenerapy project aims to develop a new medical implant for the controlled release of beta interferon (IFN-β) treatment into the body for treating Multiple Sclerosis (MS) patients. By replacing standard interferon delivery with this implant the aim is to improve treatment effectiveness with fewer side effects and lower healthcare costs, improving the quality of life of MS patients. The aim of this study is to measure the current quality of life and health status of MS patients.
Who can participate?
Patients aged 18 and over with MS
What does the study involve?
The survey asks questions about participants' disease, treatment, health status and quality of life. They only have to fill in the survey once and it takes about 15-20 minutes to fill out.
What are the possible benefits and risks of participating?
There are no physical, legal or economic risks associated with participation in this study. Participants do not have to answer questions that they do not wish to answer. Participation is voluntary and can stop at any time.
Where is the study run from?
Erasmus School of Health Policy & Management at the Erasmus University Rotterdam (Netherlands)
When is the study starting and how long is it expected to run for?
January 2019 to October (updated 19/08/2020, previously: December 2019)
Who is funding the study?
European Union Horizon 2020
Who is the main contact?
L.A.Visser
l.a.visser@eshpm.eur.nl
Trial website
Contact information
Type
Public
Primary contact
Mrs Laurenske Visser
ORCID ID
http://orcid.org/0000-0002-1478-813X
Contact details
Bayle Building
Burgemeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
+31 (0)10 408 8648
l.a.visser@eshpm.eur.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
MEC-2018-1636
Study information
Scientific title
The quality of life of multiple sclerosis patients in Europe
Acronym
QOLMSE
Study hypothesis
The aim of this study is to asses the current quality of life and health status of multiple sclerosis patients in five European countries (including the United Kingdom, the Netherlands, France, Germany and Italy).
Ethics approval
Approved 28/01/2019, The Erasmus MC Medical Ethics Review Committee (Postbus 2040, 3000 CA Rotterdam, Tel: +31 (0)10 7033625 extension nr 34428; Email: metc@erasmusmc.nl), ref: MEC-2018-1636
Study design
Observational cross-sectional survey
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Internet
Trial type
Quality of life
Patient information sheet
https://optogenerapy.eu/wp-content/uploads/2019/05/EN_InformedConsent_ENGLISH-1.pdf
Condition
Multiple sclerosis
Intervention
The online questionnaire consists of questions about patient demographics, clinical characteristics, quality of life measures (using the multiple sclerosis quality of life (MSQOL)-54), health state (using the EuroQol 5 Dimensions (EQ-5D-5L)). The questionnaire will be made available in five languages (Dutch, French, English, German and Italian). Official translations of the MSQOL-54 and EQ-5D-5L will be used and the remaining questions will be translated. Patients that choose to participate in the questionnaire will only have to fill it out once.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Quality of life measured using MSQOL-54
2. Health status measured using EQ-5D-5L
Both outcomes measured at a single timepoint, when the participant fills out the questionnaire
Secondary outcome measures
Clinical and treatment characteristics, measured by questionnaire at a single timepoint, when the participant fills out the questionnaire
Overall trial start date
07/01/2019
Overall trial end date
01/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients diagnosed with clinically definite multiple sclerosis (relapsing-remitting MS, secondary progressive MS, primary progressive MS)
2. Age 18 years or older
3. No restrictions whether patients are or are not using immunomodulatory therapy, or have used other therapies in the past
4. Participants have to have access to internet and the OPTOGENERAPY website to fill in the online questionnaire
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Total final enrolment
182
Participant exclusion criteria
Patients with a co-morbidity that negatively influences their cognition (for example dementia, stroke)
Recruitment start date
26/06/2019
Recruitment end date
31/12/2019
Locations
Countries of recruitment
France, Germany, Italy, Netherlands, United Kingdom
Trial participating centre
Erasmus School of Health Policy & Management, Erasmus University Rotterdam
Bayle Building
Burgermeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
Trial participating centre
CIC Neurosciences, Institut de Cerveau et de la Moelle epiniere ICM
Hospital Petie-Salpetriere
47-83 bd de l'Hospital
Paris
75651 PARIS CEDEX 13
France
Sponsor information
Organisation
Erasmus School of Health Policy & Management
Sponsor details
Bayle Building
Burgemeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
+31 (0)10 408 8648
l.a.visser@eshpm.eur.nl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Horizon 2020 grant agreement No 720694.
Alternative name(s)
European Union Framework Programme for Research and Innovation, EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
Publish the quality of life and health status results of the participants in 2020-2021.
IPD sharing statement
The trial data will only be used by the researchers within the same research field at the Erasmus University Rotterdam for patient confidentiality reasons. The research data be made available (for example to check on scientific integrity) to a person outside the research group, only if truly necessary.
Intention to publish date
01/10/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list