Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration (PANDA)
Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".
Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.
After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.
The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Creteil
-
Créteil, Creteil, 프랑스, 94000
- Marciano Joelle
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patient up to 55 years old
- wet AMD
- diagnostic questionnaire group: patient being announced with AMD for less than 1 month
- disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months
Exclusion Criteria:
- dry AMD
- patient under 55 years old
- patient who doesn't speak French
- patient carrying an ophtalmologic genetic disorder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Description of the patient's feelings
기간: up to 1 month after diagnosis
|
A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis.
they can also explain their feelings by themselves.
|
up to 1 month after diagnosis
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
score of general satisfaction
기간: up to 1 month after diagnosis
|
the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)
|
up to 1 month after diagnosis
|
|
score on a comprehension quiz on AMD
기간: up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
Score on a composite score evaluating the clarity of medical explanations
기간: up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
Score on a composite score evaluating the clarity of medical explanations
기간: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
score of satisfaction of announcement conditions
기간: up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
score of satisfaction of announcement conditions
기간: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
score of satisfactions regarding the clarity of the disease course and treatment explanations
기간: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
Score on the anxiety PHQ9 questionnaire
기간: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
Score on the anxiety GAD7 questionnaire
기간: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .