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OpenTrials
Completed

NCT Number: NCT03690505

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

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.

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Key information

Age range

50 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Ophtalmologie

Limoges, 87042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interviews

Behavioral

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

Primary outcomes

  1. Knowledge of AMD

    Time frame: 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

  2. Social vulnerability

    Time frame: 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 outcomes

  1. Health literacy.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: DEMELE

Important dates

Study start
2019
Primary completion
2019
Study completion
2023
First posted
Oct 1, 2018
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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