Protocol ACHTSAM study protocol: outreach diagnostics and assessment of tolerability in severe ME/CFS—a pilot study 2026 Fricke et al

[Andy]

Abstract​

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.

Open access

 

[Utsikt]

They list a lot of tests they are going to do. I have no idea why they’d do most of them for the process of determining the right diagnosis.

There are two phases, which presumably means two separate home visits.

Phase 2a and 2b include activities with an expected total duration of 85 and 75 minutes, respectively. Both phases include a 30 minute long cognitive assessment with numerous tests.

I really don’t understand what they are trying to achieve.