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Fatigue

FDDA Utilization Study (FDDAU)

Sponsored by Vifor Pharma, Inc.

About this trial

Last updated 2 years ago

Study ID

VP-NIS-CH-FFDA-U-05.2016

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

This utilization study originally aimed to investigate whether the FDDA could facilitate the differential diagnosis of fatigue and its associated symptoms and consecutively could improve the management and symptoms of fatigue. Furthermore, it aimed at investigating the time until diagnosis, the cause of fatigue, the treatment of fatigue, improvement of fatigue symptoms after treatment, the level of satisfaction of the patients resulting from treatment, time until improvement, improvement of subjective general wellbeing, referrals to other medical specialties and number of visits at physician's office because of fatigue. The planned endpoints, comparing outcomes in patients diagnosed with and without the help of the FDDA were as follows: Primary endpoint: Patient global impression of change (PGIC) at 3 months. Secondary endpoints: Patient global impression of change (PGIC) at 6 months; Percentage of patients having experienced a fatigue reduction ≥1 point (NRS); 3 or 6 months after the first visit; Time until an improvement of fatigue ≥1 point (NRS); Mean number of points of fatigue reduction (NRS); Percentage of patients with a PGIC indicating response (=any improvement) after 3 months, 6 months and 3 or 6 months; GP confidence in the established diagnosis; Clinical global impression of change (CGIC); Patient satisfaction of quality of care (diagnosis and treatment); Number of required visits for the same condition; Number of imaging or health services (specialist referrals); required for the diagnosis (MRI, radiograph, etc.); Time to final diagnosis.

What are the participation requirements?

Yes

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.

No

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".

Locations

Location

Status