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

Primary Purpose

Age-related Macular Degeneration (AMD)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interviews
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Age-related Macular Degeneration (AMD)

Eligibility Criteria

50 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'OphtalmologieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assessment

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2018
Last Updated
June 27, 2019
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT03690505
Brief Title
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Acronym
DEMELE
Official Title
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration (AMD)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assessment
Arm Type
Other
Arm Description
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Intervention Type
Behavioral
Intervention Name(s)
Interviews
Intervention Description
informant-based questionnaire semi-structured individual interviews focus group interviews
Primary Outcome Measure Information:
Title
Knowledge of AMD
Description
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
Time Frame
throughout the study, 2 years at maximum
Title
Social vulnerability
Description
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
Time Frame
throughout the study, 2 years at maximum
Secondary Outcome Measure Information:
Title
Health literacy.
Description
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
Time Frame
throughout the study, 2 years at maximum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Catherine DE SOUSA, Nurse
Phone
05 55 05 64 79
Email
InfirmieresConsultOphtalmo@chu-limoges.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine DE SOUSA
Phone
05 55 05 64 79
Email
InfirmieresConsultOphtalmo@chu-limoges.fr
Facility Information:
Facility Name
Service d'Ophtalmologie
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine DE SOUSA, Nurse
Phone
05 55 05 64 79
Email
InInfirmieresConsultOphtalmo@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Carine PEREZ
Phone
05 55 05 64 79
Email
Carine.Perez@chu-limoges.fr

12. IPD Sharing Statement

Learn more about this trial

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

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