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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02645812
Other study ID # EAMG- RB 14.062
Secondary ID
Status Recruiting
Phase N/A
First received January 4, 2016
Last updated July 11, 2016
Start date March 2016
Est. completion date September 2017

Study information

Verified date June 2016
Source University Hospital, Brest
Contact Christian Berthou
Email christain.berthou@chu-brest.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in routine as well as research oriented clinical practice.

Various questionnaires measuring fatigue have been developed, but few have been validated in french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one study. BFI (Brief Fatigue Inventory) has been translated but never validated in french language.

The main purpose of this study is to validate psychometrically the french version of BFI.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Consultation for fatigue as symptĂ´me principal ( isolated or asociated with other symptomes).

Exclusion Criteria:

Pregnancy Psychosis. Unable to complete questionnaire Phsyiological fatigue due to effort and reversible rest. Post-traumatic stress disorder -

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Cabinet Brest Centre Brest
France Cabinet Brest Centre Brest
France Cabinet Brest Centre Brest
France Cabinet Brest Centre Brest
France Cabinet Brest Centre Brest
France Cabinet Camaret/mer Camaret/mer
France Cabinet Ergue Gaberic Ergue Gaberic
France Cabinet Ergue Gaberic Ergue Gaberic
France Cabinet Ergue Gaberic Ergue Gaberic
France Cabinet Lamneur Lanmeur
France Cabinet Lamneur Lanmeur
France Cabinet Lanmeur Lanmeur
France Cabinet Lanmeur Lanmeur
France Cabinet Lanmeur Lanmeur
France Cabinet Le Guilvinec Le Guilvinec
France Cabinet Le Guilvinec Le Guilvinec
France Cabinet Le Guilvinec Le Guilvinec
France Cabinet Lesconil Lesconil
France Cabinet Penmarch Penmarch
France Cabinet Plouegat Guerrand Plouegat Guerrand
France Cabinet Quimper Quimper
France Cabinet Rosporden Rosporden
France Cabinet Rosporden Rosporden

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 9 points of BFI, each of them between 0 to 10. of BFI 3 Months No
See also
  Status Clinical Trial Phase
Recruiting NCT03542721 - Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation Phase 4