MonSter Study, Telemonitoring and Connected Care Applied to Multiple Sclerose
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.
Multiple sclerosis (MS) is the most common neurological disorder (1:500-1000) in young adults. It has a profound impact on all aspects of human functioning. The clinical picture is comprehensive fatigue and often cognitive problems that negatively influenced the quality of life, but also the consultations in the hospital. MS is not curable. In recent years new treatments have become available. These are more effective (can slow down or even stop MS) but also have more side effects and are more expensive.
The researchers plan that April 29, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in December 31, 2025.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05242731.
