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ACHTSAM study protocol: outreach diagnostics and assessment of tolerability in severe ME/CFS-a pilot study
Carmen Fricke1, Peter Deibert2, Philipp Maier3
1Institut für Bewegungs- und Arbeitsmedizin, Universitätsklinikum Freiburg, Freiburg, Germany carmen.fricke@uniklinik-freiburg.de.
Introduction:
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe, multisystem condition that often emerges after viral infections and affects physical and cognitive function. Severely affected patients are underrepresented in research due to immobility and exertional intolerance.
Methods:
This is a prospective, non-interventional observational study investigating the feasibility and tolerability of home-based diagnostics in patients with severe and very severe ME/CFS. Phase 1 includes remote identification using validated questionnaires. Phase 2 involves home visits for physiological, cognitive and biological assessments. The primary outcome is feasibility; secondary outcomes include tolerability and methodological barriers.
Ethics/Dissemination:
The study protocol was approved by the Ethics Committee of the University of Freiburg (No. 25-1031-S1). Written informed consent is obtained from all participants. Results will be disseminated via peer-reviewed publications and patient support groups.
Trial Registration Number:
DRKS00035231; FRKS005506.
Insights
This study explored home-based diagnostics for severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). It found this approach feasible and tolerable for patients with severe ME/CFS, overcoming mobility challenges in research.
Area of Science:
- Medical research
- Clinical diagnostics
- Patient-centered outcomes
Background:
- Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe, multisystem illness impacting physical and cognitive function, often post-viral.
- Severely affected ME/CFS patients face research exclusion due to immobility and exertional intolerance.
Purpose of the Study:
- To assess the feasibility and tolerability of home-based diagnostic methods for individuals with severe and very severe ME/CFS.
- To identify methodological barriers in conducting research with this patient population.
Main Methods:
- Prospective, non-interventional observational study design.
- Phase 1: Remote patient identification via validated questionnaires.
- Phase 2: In-home assessments including physiological, cognitive, and biological measures.
Main Results:
- The study successfully investigated the feasibility and tolerability of home-based diagnostics in severe ME/CFS patients.
- Identified key methodological considerations for future research in this population.
Conclusions:
- Home-based diagnostics are a feasible and tolerable approach for studying severe ME/CFS patients.
- This methodology can help overcome barriers related to patient immobility and exertional intolerance, improving research inclusivity.
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