Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT05861492
Eligibility Criteria:
Inclusion Criteria:
Physicians:
* Established physicians with specialization in general internal medicine (GP).
* Regular consultation of patients with a complaint of a not yet explained fatigue (between 1 every 2 weeks and 5 per week)
Patients:
* 18 to 80 years old
* Male or female
* Fatigue of not yet explained origin
* The reason for encounter had to be fatigue (as a main symptom) of not yet explained origin, which had lasted for at least 2 weeks, but no longer than 2 years before inclusion.
* Subject (or legally acceptable representative) had provided the appropriate written informed consent. Subject had to provide written informed consent before any study-specific procedures were performed.
Exclusion Criteria:
Physicians:
* Works in/or is related to an iron center (a medical center known to be primarily inclined to prescribing intravenous iron supplements in cases of fatigue)
* Known as being experienced in fatigue or CFS (more than five patients per week) Specialized in psychosomatic medicine (in Switzerland: "Fähigkeitsausweis SAPPM / Attestation ASMPP")
* Physicians having a sub-specialty (other than internists working as GPs in a private practice)
* Participation in the feasibility evaluation (excl. for utilization study)
Patients:
* Subject had known pre-existing anemia
* Subject with previous treatment of fatigue by a medical doctor during the last 3 months
* Subject had any pre-known disease, which is responsible for patient's fatigue with a high probability, according to GP's judgement (e.g., CHF, CKD, IBD, RA, MS, Cancer, etc...).
* Subject was known to take any drugs, which could be responsible for inducing fatigue symptoms, according to GP's judgement (e.g., antihistamines, antidepressants, benzodiazepines, hypnotics, anxiolytics, opioid formulations, etc…).
* Subject had a history of drug or alcohol abuse within 2 years prior to the 1st study visit (V1).
* Subject was currently enrolled or had completed any other clinical trial \< 30 days prior to 1st study visit (V1).
* Subject had previously participated in the "The Fatigue Differential Diagnosis Aid (FDDA) for General Practitioners: Feasibility study".
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05861492
Study Brief:
Protocol Section:
NCT05861492