NCT02932982

Brief Summary

Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

11 active sites

Status
terminated

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

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

October 21, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

October 12, 2016

Last Update Submit

November 19, 2018

Conditions

Keywords

primary carechest paindyspnea

Outcome Measures

Primary Outcomes (1)

  • calculate the accuracy of the sense of alarm the general practitioner face a patient consultant for chest pain or dyspnea.

    Questionary

    4 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients between 18 and 80 years and consulting on primary care for chest pain or dyspnea

You may qualify if:

  • Patients between 18 and 80 years
  • Patients consulting on primary care for chest pain or dyspnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

LE GOFF Delphine

La Forêt Landerneau, France, 29800, France

Location

ABALAIN-VOREUX Aurélie

Brest, 29200, France

Location

SIMON Benjamin

Brest, 29200, France

Location

AUFFRET Jean François

Camaret-sur-Mer, 29570, France

Location

POINOT Anne

Guerlesquin, 29248, France

Location

BEURTON-COURAUD Lucas

Pleyben, 29190, France

Location

LE DUFF Nicolas

Ploudalmézeau, 29830, France

Location

BODIN Bénédicte

Plounéour-Trez, 29890, France

Location

CAM Françoise

Plouzané, 29280, France

Location

LOSQUIN André

Pont-l'Abbé, 29120, France

Location

MAHE Gwénaëlle

Saint-Nicolas-du-Pélem, 22480, France

Location

Related Publications (1)

  • Barais M, Fossard E, Dany A, Montier T, Stolper E, Van Royen P. Accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study. BMJ Open. 2020 Feb 18;10(2):e034348. doi: 10.1136/bmjopen-2019-034348.

MeSH Terms

Conditions

Chest PainDyspnea

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

October 21, 2016

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations