to develop and explore measuring methods using conventional smartphones to quantify fatigue, disease activity, and short term and long progression in a day-to-day setting in patients with MS. Key research questions: - Are the NeuroKeys and MS Sherpa…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Fatigue: mobile application metrics (NeuroKeys and MS sherpa) and clinical
outcomes (FSS, Fatigue Severity Scale; CIS20R, Checklist Individual Strength;
and MFIS, Modified Fatigue Impact Scale).
- Disease activity: mobile application metrics (NeuroKeys and MS Sherpa) and
clinical outcomes (occurrence of MS relapse, new or enlarging T2 lesions, T1
gadolinium (Gd)-enhancing lesions).
- Disease progression: mobile application metrics (NeuroKeys and MS Sherpa) and
clinical outcomes (EDSS, Expanded Disability
Status Scale; MSFC, Multiple Sclerosis Functional Composite; BICAMS, Brief
International Cognitive Assessment for MS; AMSQ, Arm function in Multiple
Sclerosis Questionnaire; retinal nerve fibre layer and ganglion cell
layer-inner plexiform layer thickness, brain volume).
Secondary outcome
Quality of life
Degree of physical activity/mobility
Sleep
Background summary
The frequency of clinical visits in the current care for pwMS is limited and
current methods of monitoring clinical outcomes, such as fatigue, disease
activity and disease course, might not capture important clinical events. For
example, limitations include high subjectivity and the obtrusive nature in
which fatigue is currently assessed. Day-to-day digital self-monitoring might
provide useful for clinical use.
Study objective
to develop and explore measuring methods using conventional smartphones to
quantify fatigue, disease activity, and short term and long progression in a
day-to-day setting in patients with MS. Key research questions:
- Are the NeuroKeys and MS Sherpa mobile applications valid, reliable and
responsive in measuring fatigue?
- Is it possible to measure and predict disease activity and disease
progression with the data collected through either or both mobile applications
on both the short and long term?
Study design
Prospective observational cohort study
Study burden and risks
The burden of participation consists of 6 clinical visits of 2 hours each at
the Amsterdam UMC (physical tests and examinations, cognitive tests, magnetic
resonance imaging, and optical coherence tomography), questionnaires at home (7
times 1 hour), and performing tasks on the mobile phone (5 minutes a week).
Aside from intravenous injection of gadolinium, no invasive procedures will be
performed. The risks are the same as during standard clinical practice. There
is no direct benefit for the participants.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 65 years.
- Diagnosis of MS (revised McDonald 2017 criteria)
- Regular usage of a smartphone with iOS 10 (or higher) or Android 5.0 (or
higher), front-facing camera, and minimal screen size of 3.7 inches or 9.4
centimeters.
Exclusion criteria
- EDSS 7.5 or higher at baseline screening.
- Clinical or radiological disease activity or changes in disease modifying
drugs two months prior to baseline screening.
- Clinically relevant visual disturbances
- Confirmed (history of) relevant mood disorders, and symptoms of the mood
disorder at baseline screening
- Co-morbid sleeping disorders
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 | NL63705.029.17 |