Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05242731 |
| Other study ID # |
MonSter75251 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2021 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Isala |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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. Careful monitoring based on effectiveness and side effects is therefore important.
The result is a high frequency of hospital visits and a great burden on the patient. This
great burden is expressed in an increase in the fatigue and cognitive problems that are
already present, so the consultation in the hospital provides less information and is less
efficient than desired.
Research has also shown, for example, that the complaints that MS patients discuss are mainly
from the last 2 weeks. Previous complaints thus remain out of the picture
The aim is to optimize care for MS patients and to improve their quality of life. The costs
will also be considered. The telemonitoring will be done by MSmonitor-Plus program with video
calling care (MPVC). The MS patients fill in specific questionnaires every 3 months in the
MSmonitor Plus. The healthcare professionals (HCP) can view the answers remotely and
coordinate the right care. If the telemonitoring shows that the patient is doing well, it can
be decided that the patient does not have to come to the hospital for a check-up.
By actively involving MS patients in the MSMonitor-Plus by filling in these questionnaires
every 3 months, the HCP get a better picture of the complaints.
All MS patients actively receiving treatment within Isala are eligible for this study. There
is randomization in which telemonitoring is compared with standard treatment. One group, the
control group (CG) (104) continues care as usual (CAU), the other group, the intervention
group (IG) (104) receives MSMonitor Plus and video calling care (MPVC).
During the research, both groups fill in research questionnaires every 3 to 6 months in an
electronic case report form (Research Manager). These questionnaires are about general
health, MS, health care consumption, autonomy, and quality of life are compared afterward.
A cost-effectiveness analysis will be made of both groups. The study will last a total of 2
years for the participating patients. Previous studies have been done with MSM, but not for a
long period.
