- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03690505
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place (DEMELE)
Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail
The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):
(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives
This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.
This a 3 steps study:
- 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
- Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
- Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Catherine Catherine DE SOUSA, Nurse
- 전화번호: 05 55 05 64 79
- 이메일: InfirmieresConsultOphtalmo@chu-limoges.fr
연구 연락처 백업
- 이름: Catherine DE SOUSA
- 전화번호: 05 55 05 64 79
- 이메일: InfirmieresConsultOphtalmo@chu-limoges.fr
연구 장소
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-
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Limoges, 프랑스, 87042
- 모병
- Service d'Ophtalmologie
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연락하다:
- Catherine DE SOUSA, Nurse
- 전화번호: 05 55 05 64 79
- 이메일: InInfirmieresConsultOphtalmo@chu-limoges.fr
-
연락하다:
- Carine PEREZ
- 전화번호: 05 55 05 64 79
- 이메일: Carine.Perez@chu-limoges.fr
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient with AMD (neovascular and atrophic) whatever the stage of the disease
- Patient over 50
- Patient affiliated to a social security scheme
- Written informed consent of the patient
Exclusion Criteria:
- Patient unable to understand the information, fill out the questionnaires
- Patient with diabetic retinopathy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: Assessment
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
|
informant-based questionnaire semi-structured individual interviews focus group interviews
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Knowledge of AMD
기간: throughout the study, 2 years at maximum
|
Assesment concern patients knowledge of AMD disease, the treatment of AMD, the diagnostic of AMD and the knowledge on the AMD risk factors A 12 items standardised questionnaire will be used
|
throughout the study, 2 years at maximum
|
Social vulnerability
기간: throughout the study, 2 years at maximum
|
Assessed by EPICES scale (Evaluation of Precariousness and Health Inequalities in the Health Examination Centers).
It is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness.
Compsed of 11 items .
4 unfavorable answers indicate a Social vulnerability
|
throughout the study, 2 years at maximum
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Health literacy.
기간: throughout the study, 2 years at maximum
|
Assessed by the Health Literacy Questionnaire (HLQ) scale. It has nine scales that each measure an aspect of the multidimensional construct of health literacy. Higher scores assess for an good health literacy |
throughout the study, 2 years at maximum
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .