FDDA Utilization Study (FDDAU)

NCT05861492 | Terminated DMC

• 1 other identifier: VP-NIS-CH-FFDA-U-05.2016
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Keywords

Fatigue; General Practitioner; Differential Diagnosis Aid; PGIC; FDDA; GP

Outcome Measures

Primary Outcomes (1)

• PGIC 3 months

  Patient Global Impression of Change (PGIC) at 3 months. It reflects any change in patient condition. It consists of 7 grade scale: "very much improved", "greatly improved", "slightly improved", "no change", "slightly worsened", "greatly worsened", "very much worsened". "Very much improved" being the greater improvement state of the patient condition and "Very much worsened" being the worst change in patient condition.

  3 months

Secondary Outcomes (14)

• PGIC 6 months

  6 months

• Fatigue reduction 3 or 6 months

  3 or 6 months

• Time to improvement

  1 to 6 months

• Mean fatigue reduction

  1 to 6 months

• PGIC improvement 3 and/or 6 months

  3 and/or 6 months

Study Arms (2)

FDDA Group

ACTIVE COMPARATOR

Fatigue anamnesis was done with the help of the Fatigue Differential Diagnosis Aid.

Other: Fatigue Differential Diagnosis Aid

Non-FDDA group

NO INTERVENTION

Fatigue anamnesis was done without the help of the Fatigue Differential Diagnosis Aid.

Interventions

Fatigue Differential Diagnosis Aid OTHER

The Fatigue Differential Diagnosis Aid is a systematic questionnaire covering the symptoms and signs of fatigue and the collateral clinical data trying to facilitate the diagnostic process in the care of patient with symptoms of fatigue.

FDDA Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• to 80 years old
• Male or female
• Fatigue of not yet explained origin
• 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.

You may not qualify if:

• 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".

Sponsors & Collaborators

• Vifor Pharma, Inc.: lead

Study Sites (1)

QualiPro Schweiz AG

Kriens, Canton of Lucerne, 6010, Switzerland

Location

Related Publications (1)

• von Kanel R, Neuner-Jehle S, Kressig RW, Guessous I, Krayenbuhl PA, Zimmerli L, Angelilo-Scherer A, Keller T, Elzner C, Pauls K, Morin N, Battegay E. Effects of a novel differential diagnosis aid for managing patients with unexplained fatigue in primary care: a prospective randomized, controlled, open and multicenter study in primary care. BMC Prim Care. 2025 May 24;26(1):183. doi: 10.1186/s12875-025-02873-3.

  PMID: 40413405 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland von Kändel, Prof. Dr.

  Universitätsspital Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

• Edouard Battegay, Prof. Dr.

  Merian Iselin Klinik, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: Data on current practice was collected by GPs, each providing one patient with unexplained fatigue. None of the GPs used the FDDA. Phase 2: The GPs of phase 1 were randomized to two groups (1:1) with half of the GPs in each group. Group 1 including additional patients without using the FDDA (control group). Group 2 including additional patients while using the FDDA (experimental group).

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 17, 2023
• Study Start: March 8, 2017
• Primary Completion: April 1, 2021
• Study Completion: July 8, 2021
• Last Updated: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)