Hoving, M. http://orcid.org/0000-0003-2781-8139
Jongen, P. J.
Evers, S. M. A. A.
Edens, M. A.
Zeinstra, E. M. P. E.
Funding for this research was provided by:
National Multiple Sclerosis Foundation (OZ2020-001)
Innovatie en wetenschapsfonds Isala (20.015)
Article History
Received: 1 September 2022
Accepted: 28 October 2022
First Online: 12 November 2022
Declarations
:
: All participants consent to participate in the study by signing an informed consent.Depending on the assessment of an HCP or investigator, a patient or caregiver may stop participating in the study. The reason will be filled out in the eCRF and in the Electronic Patient File.A participant may discontinue at any time, without giving a reason.At the start of the study, participants are informed that completing the questionnaires in the eCRF will require a maximum of 30 minutes (at baseline and after 1 year). In the explanatory e-mail with link to the questionnaires a note will be added stating that the completion of the questionnaires can be spread over 3 consecutive days. The participant can also stop in between, as the answers are saved.The use of MPVC may have different effects on patients, both positive - such as promoting self-efficacy, autonomy and shared decision-making, resulting in improved quality of life - and negative – such as confronting symptoms, disabling conditions and limitations.On February 16, 2022 the trial was retrospectively registered on Clinical Trials.gov, Trial registration number: NCT05242731.On February 08, 2021 the protocol was approved by the Medical Ethics Committee (METC) of Isala Hospital Zwolle, reference number 201137. On March 23, 2021, the protocol was approved by Isala’s Board of Directors.This study will be monitored according to Good Clinical Practice guidelines.
: Not applicable.
: The author(s) declared no potential conflicts of interest with respect to the research.Dr. P.J. Jongen had received honoraria from Bayer Netherlands for consultancy activities. Dr. E.M.P.E. Zeinstra has received honoraria in connection with studies, teaching, and advisory boards from: Biogen, Genzyme, Merck, Novartis, Roche and Teva.