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FDDA Utilization Study (FDDAU)

NCT05861492 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2023-05-17

No results posted yet for this study

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

Interventions

OTHER

Fatigue Differential Diagnosis Aid

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.

Sponsors & Collaborators

  • Vifor Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Roland von Kändel, Prof. Dr. · Universitätsspital Zürich, Switzerland

  • Edouard Battegay, Prof. Dr. · Merian Iselin Klinik, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2021-04-01
Completion
2021-07-08

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05861492 on ClinicalTrials.gov