- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02636543
Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments (LIPEG)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Montpellier, 프랑스, 34295
- CHRU de Montpellier - Hôpital Arnaud de Villeneuve
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Rennes, 프랑스, 35203
- CHU de Rennes - Hôpital Sud
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Toulouse, 프랑스, 31059
- CHU de Toulouse - Hôpital Purpan
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Aquitaine
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Bordeaux, Aquitaine, 프랑스, 33000
- University Hospital Bordeaux
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Strasbourg, Aquitaine, 프랑스, 67080
- Hôpital Universitaire de Strasbourg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- 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).
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Group 2a-patient
75 patients who attended a genetic counselling consultation.
|
Oral questionnaire after the reading of letter B.
|
|
Group 2a-public
75 persons belonging to general population.
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Oral 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-).
|
Oral questionnaire after the reading of letter B.
Oral questionnaire after the reading of letters A and B during individual interview.
|
|
Group 2b-public
75 persons belonging to general population (those persons are different than patients from group 2a).
|
Oral questionnaire after the reading of letter B.
Oral questionnaire after the reading of letters A and B during individual interview.
|
|
Group 2b-professional
75 genetic professionals.
|
Oral questionnaire after the reading of letter B.
Oral questionnaire after the reading of letters A and B during individual interview.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Score of understanding questionnaire after reading letter B.
기간: 1 day
|
1 day
|
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Proportion of persons who prefer the letter B.
기간: 1 day
|
1 day
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Cécile ZORDAN, Ms, University Hospital, Bordeaux
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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