Clinical trial NCT05242731: Telemonitoring and Connected Care Applied to Multiple Sclerose
Official title: MonSter Study, Telemonitoring and Connected Care Applied to Multiple Sclerose
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, randomized control, non inferiority trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

The participant is an MS patient who is being treated within the Isala. Is 18 years of age or older Has digital skills

The caregiver is the caregiver of an MS patient Is older than 18 years

Exclusion Criteria:

The patient does not master the Dutch language. The patient has insufficient computer skills. Disabled adults are excluded from the study.

Primary outcomes:
measure: The primary endpoint is Multiple Sclerose Quality of Life (MSQuol54)
timeFrame: 2 years
Secondary outcomes:
measure: Impact on participation and autonomy (IPA)
timeFrame: 2 years
measure: Work together on health (PIH)
timeFrame: 2 years
measure: Health questionnaire (Eq5D-5L)
timeFrame: 2 years
measure: MS Self-Efficacy Scale (MSSES)
timeFrame: 2 years
measure: Medical Consumption Questionnaire (iMCQ)
timeFrame: 2 years
measure: Productivity Costs Questionnaire (iPCQ)
timeFrame: 2 years
measure: Patient satisfaction questionnaire (PTO)
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
state: Nederland
city: Maastricht
country: Netherlands
facility: University of Maastricht
state: Nederland
city: Nijmegen
country: Netherlands
facility: MS4research Institute
state: Nederland
city: Zwolle
country: Netherlands
facility: Isala
state: Nederland
Study officials:
affiliation: Isala
name: Dr E. (Esther) Zeinstra
role: STUDY_DIRECTOR
affiliation: Maastricht
name: Prof. S (Silvia) Evers
role: STUDY_DIRECTOR
References:
citation: Hoving M, Jongen PJ, Evers SMAA, Edens MA, Zeinstra EMPE. 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. BMC Neurol. 2022 Nov 12;22(1):423. doi: 10.1186/s12883-022-02948-z.