APPS MS: smartphone monitoring in MS

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27724

Enrollment

125

Registered

2018-06-12

Start date

2018-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Multiple sclerosis (MS)

Interventions

None listed

Eligibility

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 and clinical outcomes (FSS, Fatigue Severity Scale; CIS20R, Checklist Individual Strength; and MFIS, Modified Fatigue Impact Scale). - Disease activity: mobile application metrics (NeuroKeys and Mijn Kwik) and clinical outcomes (occurrence of MS relapse, MRI-lesions). - Disease progression: mobile application metrics and clinical outcomes (EDSS, Expanded Disability Status Scale; MSFC, Multiple Sclerosis Functional Composite; BICAMS, Brief International Cognitive Assessment for MS; MRI; OCT, Optical Coherence Tomography).	—

Measure

Time frame

- Fatigue: mobile application metrics and clinical outcomes (FSS, Fatigue Severity Scale; CIS20R, Checklist Individual Strength; and MFIS, Modified Fatigue Impact Scale). - Disease activity: mobile application metrics (NeuroKeys and Mijn Kwik) and clinical outcomes (occurrence of MS relapse, MRI-lesions). - Disease progression: mobile application metrics and clinical outcomes (EDSS, Expanded Disability Status Scale; MSFC, Multiple Sclerosis Functional Composite; BICAMS, Brief International Cognitive Assessment for MS; MRI; OCT, Optical Coherence Tomography).

—

Secondary

Measure	Time frame
- Quality of life (MSIS-29, Multiple Sclerosis Imapct Scale; SF-36, Short Form Health Survey).	—

Contacts

Public ContactK.H. Lam

De Boelelaan 1117

k.lam1@amsterdamumc.nl+31204440717

Outcome results