Telemonitoring and Connected Care Applied to Multiple Sclerose

NCT05242731 | Unknown DMC

• 1 other identifier: MonSter75251
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is Multiple Sclerose Quality of Life (MSQuol54)

  The primary endpoint (MSQoL-54) at which the value of telemonitoring is determined is t=2 years.The 2 composite summary scores are the MSQOL-54 Physical Health Composite Score and the MSQOL-54 Mental Health Composite Score, The highest range is 100, de lowest 0. The lower the outcome (0) the better the quality of life. The higher the outcome (100), the worse the quality of life.

  2 years

Secondary Outcomes (7)

• Impact on participation and autonomy (IPA)

  2 years

• Work together on health (PIH)

  2 years

• Health questionnaire (Eq5D-5L)

  2 years

• MS Self-Efficacy Scale (MSSES)

  2 years

• Medical Consumption Questionnaire (iMCQ)

  2 years

Study Arms (2)

Study group

ACTIVE COMPARATOR

Studygroup: Working with MSmonitor and video calling. Complete research questionnaires every 3 months in the Case Report Form, Researchmanager.

Device: MSmonitor, a self-management/education program with e-health interventions; Device: Video calling program "Better-close"; Device: Researchmanager program

Controlgroup

ACTIVE COMPARATOR

Became care as usual (CAU), not working with MSmonitor or video calling. Complete research questionnaires every 3 months in the Case Report Form, researchmanager.

Device: Researchmanager program

Interventions

MSmonitor, a self-management/education program with e-health interventions DEVICE

A self-management/education program with e-health interventions

Study group

Video calling program "Better-close" DEVICE

Video calling program.

Study group

Researchmanager program DEVICE

Case Report Form, Datamanagement program

Controlgroup; Study group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Because there are more women with MS than men (70% female - 30% male)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Isala: lead

Study Sites (4)

University Medical Center Groningen

Groningen, Nederland, 9713AV, Netherlands

Location

University of Maastricht

Maastricht, Nederland, 6200MD, Netherlands

Location

MS4research Institute

Nijmegen, Nederland, 6522KJ, Netherlands

Location

Isala

Zwolle, Nederland, 7943KA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36371162 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr E. (Esther) Zeinstra

  Isala

  STUDY DIRECTOR

• Prof. S (Silvia) Evers

  Maastricht

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Single center, randomized control, non inferiority trial

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 16, 2022
• Study Start: April 29, 2021
• Primary Completion: April 29, 2024
• Study Completion: December 31, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

NL (4)