NCT03690505: DEMELE

Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place

Status unknown NA Last updated 28 June 2019

What this trial tests

NA trial testing Interviews in Age-related Macular Degeneration (AMD) in 200 participants. Status unknown.

Timeline

12 March 2019

Primary endpoint
1 October 2020

1 January 2021

Quick facts

Lead sponsor	University Hospital, Limoges
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	200
Start date	12 March 2019
Primary completion	1 October 2020
Estimated completion	1 January 2021
Sites	1 location across France

Drugs / interventions tested

• Interviews

Conditions studied

• Age-related Macular Degeneration (AMD) — all drugs for Age-related Macular Degeneration (AMD) →

Sponsor

University Hospital, Limoges

Who can join

50 Months and older, any sex, with Age-related Macular Degeneration (AMD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.