Transmission of Information to the Relatives After Genetic DiagnosisLIPEGNCT02636543
Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments
An observational study of Transmission of Information to the Relatives After Genetic Diagnosis, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information to the relatives after genetic diagnosis of a serious condition. This decree includes a specific model of letter that can be sent to relatives by genetic professionals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transmission of Information to the Relatives After Genetic Diagnosis
- What is being tested?
- Questionnaire after the reading of letter B. and Questionnaire after the reading of letters A and B
- Type of treatment
- Pill or oral medicine
- How many people
- 325 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2015to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Group 2a-patient: 75 patients who attended a genetic counselling consultation. * Group 2a-public: 75 persons belonging to the general population who never attended genetic counselling consultation. * Group 2b-patient: 75 patients who attended a genetic counselling consultation. * Group 2b-public: 75 persons belonging to general population who never attendeda genetic counselling consultation. These persons are different than persons from group 2a-person. * Group 2b-professionnal: 75 genetic professionals (geneticist and genetic counsellor).
Who may be able to join
- 18 years old and above
- French native speaker
- informed person
- person whose non-opposition has been received
- public: person who never attended a genetic counselling consultation
- professional: geneticist and genetic counsellors working in France
Who cannot join
- study 2a : person who took part of study 2b
- study 2b : person who took part of study 2a
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital Bordeaux
Bordeaux, Aquitaine, 33000
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHU de Rennes - Hôpital SUD
Rennes, 35203
Hôpital Universitaire de Strasbourg
Strasbourg, Aquitaine, 67080
CHU de Toulouse - Hôpital Purpan
Toulouse, 31059
About this study
The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information to the relatives after genetic diagnosis of a serious condition. This decree includes a specific model of letter that can be sent to relatives by genetic professionals. We evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public. A focus group drafted a new version of the letter (letter B) through these observations. The two letter models (A vs B) are compared in terms of impact through precise items (understanding and feelings) on three populations: patients, public and genetic professionals. Assumption is made that the letter B will be preferred to the letter A. Overall, we aim at giving a letter formulation accommodating as many people as possible to standardize practices.
Read the detailed description
The recent publication of the decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information of the relatives after genetic diagnosis of a serious condition allowing preventative or care measures. In the case a mutation career refuses to directly inform other members of his family, option is to call on services of a genetic professional for the transmission of its family information. This decree includes a specific model of letter that can be sent to relatives by genetic professionals.
The main objective of the present study is the standardization of the procedure concerning the information to relatives by all genetic professionals. It would allow the same format of information in all families involved.
The first part (study 1a) evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public, through the use of an individual and oral questionnaire. Interviews with the patients, public, genetic professionals and people who have received this letter completed the study 1a (study 1b). A focus group (accounting different genetic professionals and patient associations) composed a new version of letter (letter B) through these observations (study 1c).
The second part will compare the two letters model (A vs B) impact through precise items on three populations: patients, public and genetic professionals. This study will allow to:
- Evaluate how the letter composed by the focus group (letter A) is understood and perceived by the patients and the public with the same methodology as study 1a (study 2a) ;
- Compare the two letters model (A vs B) to describing the preference of patients, public and genetic professionals (study 2b).
The expected results would help us to choose the letter accommodating as many people as possible to standardize practices.
- Being tested
- Questionnaire after the reading of letter B., Questionnaire after the reading of letters A and B
- Keywords
- genetic diagnosis, information, letter model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire after the reading of letter B.Other
Oral questionnaire after the reading of letter B.
Questionnaire after the reading of letters A and BOther
Oral questionnaire after the reading of letters A and B during individual interview.
| Study group | Role | What they receive |
|---|---|---|
| Group 2a-patient | 75 patients who attended a genetic counselling consultation. Receives: Other: Questionnaire after the reading of letter B. | |
| Group 2a-public | 75 persons belonging to general population. Receives: Other: Questionnaire after the reading of letter B. | |
| Group 2b-patient | 75 patients who attended a genetic counselling consultation (those patients are different than patients from group 2a-). Receives: Other: Questionnaire after the reading of letter B.; Other: Questionnaire after the reading of letters A and B | |
| Group 2b-public | 75 persons belonging to general population (those persons are different than patients from group 2a). Receives: Other: Questionnaire after the reading of letter B.; Other: Questionnaire after the reading of letters A and B | |
| Group 2b-professional | 75 genetic professionals. Receives: Other: Questionnaire after the reading of letter B.; Other: Questionnaire after the reading of letters A and B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of understanding questionnaire after reading letter B.
Measured: 1 day
Proportion of persons who prefer the letter B.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transmission of Information to the Relatives After Genetic DiagnosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile ZORDAN, Ms, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636543
- Sponsor's protocol ID
- CHUBX 2014/32
- Acronym
- LIPEG
- Status last verified
- Dec 2015
- First submitted
- 17 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments
- ClinicalTrials.gov ID
- NCT02636543
- Acronym / sponsor ID
- LIPEG / CHUBX 2014/32
- Keywords
- genetic diagnosis, information, letter model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information to the relatives after genetic diagnosis of a serious condition. This decree includes a specific model of letter that can be sent to relatives by genetic professionals. We evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public. A focus group drafted a new version of the letter (letter B) through these observations. The two letter models (A vs B) are compared in terms of impact through precise items (understanding and feelings) on three populations: patients, public and genetic professionals. Assumption is made that the letter B will be preferred to the letter A. Overall, we aim at giving a letter formulation accommodating as many people as possible to standardize practices.
Detailed description
The recent publication of the decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information of the relatives after genetic diagnosis of a serious condition allowing preventative or care measures. In the case a mutation career refuses to directly inform other members of his family, option is to call on services of a genetic professional for the transmission of its family information. This decree includes a specific model of letter that can be sent to relatives by genetic professionals.
The main objective of the present study is the standardization of the procedure concerning the information to relatives by all genetic professionals. It would allow the same format of information in all families involved.
The first part (study 1a) evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public, through the use of an individual and oral questionnaire. Interviews with the patients, public, genetic professionals and people who have received this letter completed the study 1a (study 1b). A focus group (accounting different genetic professionals and patient associations) composed a new version of letter (letter B) through these observations (study 1c).
The second part will compare the two letters model (A vs B) impact through precise items on three populations: patients, public and genetic professionals. This study will allow to:
- Evaluate how the letter composed by the focus group (letter A) is understood and perceived by the patients and the public with the same methodology as study 1a (study 2a) ;
- Compare the two letters model (A vs B) to describing the preference of patients, public and genetic professionals (study 2b).
The expected results would help us to choose the letter accommodating as many people as possible to standardize practices.
Study design
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 2a-patient | – | Other: Questionnaire after the reading of letter B.75 patients who attended a genetic counselling consultation. |
| Group 2a-public | – | Other: Questionnaire after the reading of letter B.75 persons belonging to general population. |
| Group 2b-patient | – | Other: Questionnaire after the reading of letter B., Other: Questionnaire after the reading of letters A and B75 patients who attended a genetic counselling consultation (those patients are different than patients from group 2a-). |
| Group 2b-public | – | Other: Questionnaire after the reading of letter B., Other: Questionnaire after the reading of letters A and B75 persons belonging to general population (those persons are different than patients from group 2a). |
| Group 2b-professional | – | Other: Questionnaire after the reading of letter B., Other: Questionnaire after the reading of letters A and B75 genetic professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Group 2a-patient: 75 patients who attended a genetic counselling consultation. * Group 2a-public: 75 persons belonging to the general population who never attended genetic counselling consultation. * Group 2b-patient: 75 patients who attended a genetic counselling consultation. * Group 2b-public: 75 persons belonging to general population who never attendeda genetic counselling consultation. These persons are different than persons from group 2a-person. * Group 2b-professionnal: 75 genetic professionals (geneticist and genetic counsellor).
Key inclusion criteria (6 listed)
- 18 years old and above
- French native speaker
- informed person
- person whose non-opposition has been received
- public: person who never attended a genetic counselling consultation
Key exclusion criteria (2 listed)
- study 2a : person who took part of study 2b
- study 2b : person who took part of study 2a
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 |
|---|---|---|
| Questionnaire after the reading of letter B.Oral questionnaire after the reading of letter B. | Other | Group 2a-patient, Group 2a-public, Group 2b-patient, Group 2b-professional, Group 2b-public |
| Questionnaire after the reading of letters A and BOral questionnaire after the reading of letters A and B during individual interview. | Other | Group 2b-patient, Group 2b-professional, Group 2b-public |
Primary outcome
Score of understanding questionnaire after reading letter B.
Time frame: 1 day
Proportion of persons who prefer the letter B.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
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.
Cécile ZORDAN, Ms principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transmission of Information to the Relatives After Genetic Diagnosis, run by University Hospital, Bordeaux at 5 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of understanding questionnaire after reading letter B. (time frame: 1 day). The study lists 2 primary outcomes in all. 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 21 Dec 2015.