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

Recruiting

Conditions: MS
Multiple sclerosis
10012303

Registration Number: NL-OMON54476

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 210

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in the Multiple Sclerosis Self-Efficacy Scale Control score<br /><br>between patients in the intervention group and patients in the control group.</p><br>

Secondary Outcome Measures

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