Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments

Transmission of Information to the Relatives After Genetic Diagnosis Clinical Trial

— LIPEG  

Official title:

Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636543
• Other study ID #: CHUBX 2014/32
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: December 17, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• study 2a : person who took part of study 2b

• study 2b : person who took part of study 2a

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Transmission of Information to the Relatives After Genetic Diagnosis

Intervention

Other:
• Questionnaire after the reading of letter B.
Oral questionnaire after the reading of letter B.
• Questionnaire after the reading of letters A and B
Oral questionnaire after the reading of letters A and B during individual interview.

Locations

Country	Name	City	State
France	University Hospital Bordeaux	Bordeaux	Aquitaine
France	CHRU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	CHU de Rennes - Hôpital SUD	Rennes
France	Hôpital Universitaire de Strasbourg	Strasbourg	Aquitaine
France	CHU de Toulouse - Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of understanding questionnaire after reading letter B.		1 day	No
Primary	Proportion of persons who prefer the letter B.		1 day	No