NCT02645812

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

23 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 12, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

January 4, 2016

Last Update Submit

July 11, 2016

Conditions

Keywords

FatigueBrief Fatigue Inventory (BFI)Primary careGeneral Practitioners

Outcome Measures

Primary Outcomes (1)

  • 9 points of BFI, each of them between 0 to 10. of BFI

    3 Months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with fatigue symptom consulting a general practitioner

You may qualify if:

  • Consultation for fatigue as symptôme principal ( isolated or asociated with other symptomes).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Cabinet Brest Centre

Brest, 29200, France

NOT YET RECRUITING

Cabinet Brest Centre

Brest, 29200, France

NOT YET RECRUITING

Cabinet Brest Centre

Brest, 29200, France

NOT YET RECRUITING

Cabinet Brest Centre

Brest, 29200, France

NOT YET RECRUITING

Cabinet Brest Centre

Brest, 29200, France

NOT YET RECRUITING

Cabinet Camaret/mer

Camaret/mer, 29570, France

RECRUITING

Cabinet Ergue Gaberic

Ergué-Gabéric, 29500, France

NOT YET RECRUITING

Cabinet Ergue Gaberic

Ergué-Gabéric, 29500, France

NOT YET RECRUITING

Cabinet Ergue Gaberic

Ergué-Gabéric, 29500, France

NOT YET RECRUITING

Cabinet Le Guilvinec

Guilvinec, 29730, France

NOT YET RECRUITING

Cabinet Le Guilvinec

Guilvinec, 29730, France

NOT YET RECRUITING

Cabinet Le Guilvinec

Guilvinec, 29730, France

NOT YET RECRUITING

Cabinet Lamneur

Lanmeur, 29620, France

RECRUITING

Cabinet Lamneur

Lanmeur, 29620, France

NOT YET RECRUITING

Cabinet Lanmeur

Lanmeur, 29620, France

NOT YET RECRUITING

Cabinet Lanmeur

Lanmeur, 29620, France

NOT YET RECRUITING

Cabinet Lanmeur

Lanmeur, 29620, France

NOT YET RECRUITING

Cabinet Lesconil

Lesconil, 29740, France

NOT YET RECRUITING

Cabinet Penmarch

Penmarch, 29760, France

NOT YET RECRUITING

Cabinet Plouegat Guerrand

Plouegat Guerrand, 29620, France

NOT YET RECRUITING

Cabinet Quimper

Quimper, 29000, France

NOT YET RECRUITING

Cabinet Rosporden

Rosporden, 29104, France

RECRUITING

Cabinet Rosporden

Rosporden, 29140, France

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chritian Berthou

    CHRU de Brest

    STUDY DIRECTOR

Central Study Contacts

Christian Berthou

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-06

Locations