The quality of life of multiple sclerosis patients in Europe
| ISRCTN | ISRCTN78466206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78466206 |
| Secondary identifying numbers | MEC-2018-1636 |
- Submission date
- 06/08/2019
- Registration date
- 13/08/2019
- Last edited
- 14/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Public
Bayle Building
Burgemeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
 ORCID ID |
0000-0002-1478-813X |
|---|---|
| Phone | +31 (0)10 408 8648 |
| l.a.visser@eshpm.eur.nl |
Study information
| Study design | Observational cross-sectional survey |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | https://optogenerapy.eu/wp-content/uploads/2019/05/EN_InformedConsent_ENGLISH-1.pdf |
| Scientific title | The quality of life of multiple sclerosis patients in Europe |
| Study acronym | QOLMSE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 07/01/2019 |
| Completion date | 01/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 182 |
| Key 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 |
| Key exclusion criteria | Patients with a co-morbidity that negatively influences their cognition (for example dementia, stroke) |
| Date of first enrolment | 26/06/2019 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- France
- Germany
- Italy
- Netherlands
- United Kingdom
Study participating centres
Burgermeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
47-83 bd de l'Hospital
Paris
75651 PARIS CEDEX 13
France
Sponsor information
University/education
Bayle Building
Burgemeester Oudlaan 50
Rotterdam
3062 PA
Netherlands
| Phone | +31 (0)10 408 8648 |
|---|---|
| l.a.visser@eshpm.eur.nl | |
"ROR" |
https://ror.org/057w15z03 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme, European Union Framework Programme for Research and Innovation
Results and Publications
| Intention to publish date | 01/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publish the quality of life and health status results of the participants in 2020-2021. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/03/2021 | 14/04/2021 | Yes | No |
Editorial Notes
14/04/2021: Publication reference added.
19/08/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/07/2020 to 01/10/2019.
2. The intention to publish date was changed from 01/07/2020 to 01/10/2020.
3. The plain English summary was updated to reflect these changes.
10/01/2020: The total final enrolment number has been added.
12/08/2019: Trial's existence confirmed by ethics committee.
