MS Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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