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An intervention study on the effect of digital self-monitoring-based management of relapsing and remitting multiple sclerosis on self-efficacy, clinical outcomes and cost-effectiveness

An intervention study on the effect of digital self-monitoring-based management of relapsing and remitting multiple sclerosis on self-efficacy, clinical outcomes and cost-effectiveness - Multiple sclerosis self-monitoring (MSSM)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54476
Enrollment
210
Registered
2022-06-09
Start date
2022-08-15
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple sclerosis

Interventions

One group receives the MS sherpa application (~6 min/week self monitoring through a questionnaire, walking test and cognition test) in addition to standard care and the other group receives standard

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. A minimum age of 18 years. 2. Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria. 3. Have a length of disease duration of >=12 months, from date of MS diagnosis. 4. Have clinical disease activity (reported relapses) and/or radiological disease activity (new/enlarged T2 lesions or contrast-enhancing lesions) within the past 12 months. 5. Willing and able to install and use MS sherpa on own smartphone with Android (version 4.4 or higher) or iOS (version 9 or higher) operating system. 6. Willing to stay for treatment with the same hospital during the year of study. 7. Willing to follow the rules of conduct as described in Appendix A during the year of study.

Exclusion criteria

Exclusion criteria: 1. EDSS of > 6.5 at baseline screening. 2. Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa on the smartphone, as judged by the investigator. 3. Concomitant use of health monitoring apps or devices for MS during the study. 4. Concomitant participation in another intervention trial in MS.

Design outcomes

Primary

MeasureTime frame
The difference in the Multiple Sclerosis Self-Efficacy Scale Control score between patients in the intervention group and patients in the control group.

Secondary

MeasureTime frame
- To evaluate the degree to which MS sherpa reduces the uncertainty in the clinical decision-making process, with regards to start/switch/discontinuation of disease-modifying therapies, use/non-use of paraclinical tests, scheduling of follow-up consultations, and referral to specialized MS caregivers, and the degree to which MS sherpa reduces disease activity and progression. - To evaluate the effect on quality of life and cost-effectiveness of the MS sherpa app compared to care as usual without MS sherpa. - To investigate the experiences, needs and wishes of users (MS patients and healthcare providers) of the MS sherpa intervention, which can lead to the development of empirically informed guidelines for the successful adoption of self-monitoring-based disease management in the MS healthcare ecosystem.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)