To evaluate the effect of digital self-monitoring-based management of relapsing and remitting multiple sclerosis on self-efficacy, clinical outcome measures and cost-effectiveness
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in the Multiple Sclerosis Self-Efficacy Scale Control score
between patients in the intervention group and patients in the control group.
Secondary outcome
- 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.
Background summary
Increasingly, the value of digital self-monitoring through smartphone apps and
smart wearables is acknowledged for empowering patients to self-manage chronic
conditions by providing insight and a sense of control over disease, thereby
enhancing patients' autonomy and control self-efficacy (the degree in which a
person is confident to complete tasks and reach goals in specific situations).
We will investigate if the control self-efficacy of multiple sclerosis (MS)
patients is improved and if treatment decisions are made earlier if the MS
sherpa smartphone application is used in addition to standard care.
Study objective
To evaluate the effect of digital self-monitoring-based management of relapsing
and remitting multiple sclerosis on self-efficacy, clinical outcome measures
and cost-effectiveness
Study design
Multicenter, prospective, randomized controlled trial (RCT).
Intervention
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 care.
Study burden and risks
The burden consists of expenditure of time by the participant during the study
follow-up of one year: this is 4,5 hours for the controlgroup and 9,5 hours for
the interventiongroup. For each regular visit with their treating physian
patients will be asked to fill in additional questionnaires. This will take an
extra 35 minutes for each extra visit. Patients in the intervention group can
participate in interviews or a focus group. The interviews cosist of a series
of three interviews of 45-60 minutes each. The focus group is a one time event,
which will take approximately 2 hours. Potential risks are only applicable for
participants in the interventiongroup, who are at risk that decisions in the
clinical decisionmaking process are based on 'false-positive' and/or
'false-negative' results of the MS sherpa measurements. This risk, however, is
small since the MS sherpa app will be used in conjuction to standard clinical
instruments.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75687.029.22 |