Subjects Perceived as Embarrassing During a Consultation... | NCT06130605

Studies
Subjects Perceived as Embarrassing During a Consultation in General Medical Practice

NCT06130605

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Nov 14, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

General Practice

Interventions

Data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Feb 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Nov 8, 2023

First Submission Date that Met QC Criteria

Nov 8, 2023

First Posted Date

Nov 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2023

Last Update Posted Date

Nov 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Optimal medical care requires transparency and honesty. However, it is not always easy to address some issues that may be considered too personal, intimate or taboo, such as mental health, sexuality, addiction and death. Patients' approach to these issues may be influenced by the profile of their general practitioner, or by the atmosphere of the consultation.

This retention of information by the patient, whether voluntary or not, can lead to adverse events related to care due to a misunderstanding between doctor and patient.

Detailed Description

The main objective is to describe the proportion of patients limiting the subjects addressed during a general medicine consultation by gene, modesty and/or fear of judgment The secondary objective is to study the factors associated with limitation of subjects addressed by patient by gene, modesty and/or fear of judgment during a general medicine consultation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
people over the age of 18		people over the age of 18.	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Data collection	people over the age of 18

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
limitation of subjects addressed by gene, modesty and/or fear of judgment	Proportion of patients who have ever restricted the subjects discussed during a general medical consultation by gene, modesty and/or fear of judgment	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years of age
Agreeing to take part in the study

Exclusion Criteria:

Minors
Protected by law (guardianship, curatorship, safeguard of justice)
Refusing to take part in the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

people over the age of 18 agreeing to take part in the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barbe Coralie, DR	Contact	0326913665	+33	coralie.barbe@univ-reims.fr
CURRS CURRS, dr	Contact	0326918822	+33	currs@univ-reims.fr

Overall Officials

Name	Affiliation	Role
THERY MERLAND Emilie, Dr	Université de Reims Champagne-Ardenne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ufr Medecine Urca		Reims		51100	France
Université de Reims Champagne Ardenne

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided