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) Clinical Trial

— DEMELE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690505
• Other study ID #: I16027/DEMELE
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: June 2019
• Source: University Hospital, Limoges
• Contact: Catherine Catherine DE SOUSA, Nurse
• Phone: 05 55 05 64 79
• Email: InfirmieresConsultOphtalmo[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Behavioral:
• Interviews
informant-based questionnaire semi-structured individual interviews focus group interviews

Locations

Country	Name	City	State
France	Service d'Ophtalmologie	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Health literacy.	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	throughout the study, 2 years at maximum