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

Not Applicable

• Conditions: Age-related Macular Degeneration (AMD)
• Interventions: Behavioral: Interviews

• Registration Number: NCT03690505
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2019-03-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28
• Primary Completion: 2020-10-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Knowledge of AMD	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
Social vulnerability	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

Secondary Outcome Measures

Name	Time	Method
Health literacy.	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

Trial Locations

Locations (1)

Service d'Ophtalmologie; 🇫🇷 Limoges, France