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

NCT03690505 | Completed

• 1 other identifier: I16027/DEMELE
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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. 1.200 patients will be enrolled and answer a questionnaire on knowledge of the disease
2. 2.Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
3. 3.Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.

Conditions

Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (2)

• Knowledge of AMD

  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

  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

Secondary Outcomes (1)

• Health literacy.

  throughout the study, 2 years at maximum

Study Arms (1)

Assessment

OTHER

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

Behavioral: Interviews

Interventions

Interviews BEHAVIORAL

informant-based questionnaire semi-structured individual interviews focus group interviews

Assessment

Eligibility Criteria

• Age: 50 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient unable to understand the information, fill out the questionnaires
• Patient with diabetic retinopathy

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Service d'Ophtalmologie

Limoges, 87042, France

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: October 1, 2018
• Study Start: March 12, 2019
• Primary Completion: May 16, 2019
• Study Completion: January 4, 2023
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

FR (1)