Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-05 @ 10:46 AM
Study NCT ID:
NCT03690505
Status:
UNKNOWN
Last Update Posted:
2019-06-28
First Post:
2018-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Sponsor:
University Hospital, Limoges
Organization:
Study Overview
Official Title:
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEMELE
Brief Summary:
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:
1. 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
2. Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
3. Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.
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:
1. 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
2. Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
3. Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: