General PracticeGene-MGNCT06130605
Subjects Perceived as Embarrassing During a Consultation in General Medical Practice
An observational study of General Practice, run by Université de Reims Champagne-Ardenne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Practice
- What is being tested?
- Data collection
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: people over the age of 18 agreeing to take part in the study
Who may be able to join
- Over 18 years of age
- Agreeing to take part in the study
Who cannot join
- Minors
- Protected by law (guardianship, curatorship, safeguard of justice)
- Refusing to take part in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Ufr Medecine Urca
Reims, 51100
Université de Reims Champagne Ardenne
Reims, 51100
About this study
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.
Read the 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.
- Conditions
- General Practice
- Being tested
- Data collection
- Keywords
- general medical consultation, gene, modesty, fear of judgment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| people over the age of 18 | people over the age of 18. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- THERY MERLAND Emilie, Dr, Principal investigator, Université de Reims Champagne-Ardenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130605
- Sponsor's protocol ID
- 2023_RIPH_006_Gene-MG
- Acronym
- Gene-MG
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjects Perceived as Embarrassing During a Consultation in General Medical Practice
- ClinicalTrials.gov ID
- NCT06130605
- Acronym / sponsor ID
- Gene-MG / 2023_RIPH_006_Gene-MG
- Conditions
- General Practice
- Keywords
- general medical consultation, gene, modesty, fear of judgment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| people over the age of 18 | – | Other: Data collectionpeople over the age of 18. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- people over the age of 18 agreeing to take part in the study
Key inclusion criteria (2 listed)
- Over 18 years of age
- Agreeing to take part in the study
Key exclusion criteria (3 listed)
- Minors
- Protected by law (guardianship, curatorship, safeguard of justice)
- Refusing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData collection | Other | people over the age of 18 |
Primary outcome
limitation of subjects addressed by gene, modesty and/or fear of judgment
Time frame: Day 0
Proportion of patients who have ever restricted the subjects discussed during a general medical consultation by gene, modesty and/or fear of judgment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
THERY MERLAND Emilie, Dr principal investigator
Université de Reims Champagne-Ardenne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Practice, run by Université de Reims Champagne-Ardenne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie, DR (0326913665 ext. +33, coralie.barbe@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
limitation of subjects addressed by gene, modesty and/or fear of judgment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.