Assessing fatigue, disease activity and progression through smartphone surveillance in multiple sclerosis

Assessing fatigue, disease activity and progression through smartphone surveillance in multiple sclerosis - APPS MS: smartphone monitoring in MS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46691

Enrollment

125

Registered

2018-06-28

Start date

2018-08-21

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

MS Multiple sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
- 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).	—

Measure

Time frame

- 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

Measure	Time frame
Quality of life Degree of physical activity/mobility Sleep	—

Countries

Netherlands

Outcome results