Fatigue Investigation Using Digital Outcomes

Sponsor
Liliana Barrios
Study ID
NCT07783074
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
May 26, 2026
Status verified
Aug 2026
Primary completion
May 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
122 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Percentage of Expected Smartwatch Wear Time Recorded Over Two Months [ Time Frame: 2 months ]

Central Contacts

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