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Fatigue Investigation Using Digital Outcomes (FIDO) - An Exploratory Project

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

This study investigates objective methods to measure and monitor fatigue in patients with post-COVID-19 condition (long COVID) and multiple sclerosis (MS), and includes a group of healthy volunteers for comparison. Fatigue is a common and debilitating symptom of both conditions, but current assessment methods rely mainly on questionnaires, which can be limited by subjectivity and recall bias. The study uses a smartphone application (the FIDO app) together with wearable devices to continuously collect data on fatigue and its fluctuations during daily life, in order to evaluate the potential of digital, objective measures compared to standard assessments. Participation lasts approximately eight weeks and includes two in-person clinic visits along with a continuous data collection phase. At the initial visit, participants complete baseline assessments and questionnaires and are introduced to the study's digital tools. During the following weeks, participants wear two wearable devices continuously (24 hours a day) and use the FIDO app to complete short daily tasks (approximately 7 minutes every two days) and brief questionnaires (approximately 5 minutes per day). All participants collect a stool sample at home at weeks 4 and 8 for gut microbiome analysis, and complete the Fatigue Scale for Motor and Cognitive Functions at week 4. At the final study visit, participants repeat a subset of the baseline assessments, provide feedback on the digital technology used, and return the study devices.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Confirmed diagnosis of MS (by neurologist) or Long COVID (by medical doctor).

• Smartphone ownership.

• Provide written informed consent.

• Fluent in German or English.

• Smartphone ownership.

• Provide written informed consent.

• Fluent in German or English.

Locations
Other Locations
Switzerland
Neurozentrum Basel Messeturm
RECRUITING
Basel
Bellevue Medical Group - Neurozentrum Seefeld
RECRUITING
Zurich
Bellevue Medical Group - Neurozentrum Sternen / Neurozentrum Bellevue
RECRUITING
Zurich
Klinik Lengg AG
RECRUITING
Zurich
NeuroPraxis Zürich GmbH
RECRUITING
Zurich
University of Zurich
RECRUITING
Zurich
Contact Information
Primary
Liliana Barrios, Dr. sc. ETH Zürich
fido@dsi.uzh.ch
+41774141174
Time Frame
Start Date: 2026-05-26
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 122
Treatments
Multiple Sclerosis
Participants with a clinically confirmed diagnosis of multiple sclerosis (MS). This group is monitored using two wearable devices and the FIDO smartphone application over two months.~At the initial visit this cohort completes demographic questions and the following assessments: the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Hospital Anxiety and Depression Scale (HADS), COMPASS-31, and the Multiple Sclerosis Impact Scale (MSIS-29). The MSIS-29 is administered to this cohort only.
Long COVID
Participants with a clinically confirmed diagnosis of post-COVID-19 condition (Long COVID). This group is monitored using two wearable devices and the FIDO smartphone application over two months.~At the initial visit this cohort completes demographic questions and the following assessments: the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Munich Berlin Symptom Questionnaire (MBSQ), the Bell Disability Scale, the Hospital Anxiety and Depression Scale (HADS), and COMPASS-31. The MBSQ and Bell Disability Scale are administered to this cohort only, and characterise symptom severity and functional impairment.
Healthy controls
This group is monitored using two wearable devices and the FIDO smartphone application over two months. At the initial visit this cohort completes demographic questions and the following assessments: the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Hospital Anxiety and Depression Scale (HADS), and COMPASS-31.
Sponsors
Leads: Liliana Barrios
Collaborators: ETH Zurich (Switzerland), Insel Gruppe AG, University Hospital Bern, University of Zurich, Innosuisse - Swiss Innovation Agency, Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland

This content was sourced from clinicaltrials.gov