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NCT05242731: MonSter

Telemonitoring and Connected Care Applied to Multiple Sclerose

Status unknown NA Last updated 10 October 2023
What this trial tests

NA trial testing MSmonitor, a self-management/education program with e-health interventions in Multiple Sclerosis in 208 participants. Status unknown.

Timeline
29 April 2021
Primary endpoint
29 April 2024
31 December 2025

Quick facts

Lead sponsorIsala
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment208
Start date29 April 2021
Primary completion29 April 2024
Estimated completion31 December 2025
Sites4 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Isala — full company profile →

Who can join

18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators designed a new care concept based on a multi-modal version of the MSmonitor program, the 'MSmonitor-Plus and Video Calling Care' (MPVC). MPVC combines the self-management and education program MSmonitor with video consultations by using specific questionnaires designed for high-frequency/intensive self-assessments of MS patients. 'The overall objective of this study is to assess the feasibility and (cost)-effectiveness of MPVC compared to Care as Usual (CAU). An RCT with two parallel groups will be conducted to compare the MPVC with a CAU in MS patients and their caregivers. In this study, 208 MS patients will be included with follow-up measurements for two years (at baseline and every three months). After randomization, 104 patients will be assigned to MPVC and 104 patients to CAU. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. MSmonitor-plus program and video calling care (MPVC) for multidisciplinary care and self-management in multiple sclerosis: study protocol of a single-center randomized, parallel-group, open label, non-inferiority trial.
    Hoving M, Jongen PJ, Evers SMAA, Edens MA, et al · · 2022 · PMID 36371162 · DOI 10.1186/s12883-022-02948-z

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Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

Other Isala trials

Trials by the same sponsor.

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Data sources for this page

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