Condition category
Nervous System Diseases
Date applied
06/08/2019
Date assigned
13/08/2019
Last edited
13/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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

https://optogenerapy.eu/ms-patients-survey

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

01/07/2020

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

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

01/07/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/08/2019: Trial's existence confirmed by ethics committee.