Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT03690505
Status:
UNKNOWN
Last Update Posted:
2019-06-28
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of AMD', 'timeFrame': 'throughout the study, 2 years at maximum', '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'}, {'measure': 'Social vulnerability', 'timeFrame': 'throughout the study, 2 years at maximum', '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'}], 'secondaryOutcomes': [{'measure': 'Health literacy.', 'timeFrame': 'throughout the study, 2 years at maximum', '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.\n\nHigher scores assess for an good health literacy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Macular Degeneration (AMD)']}, 'descriptionModule': {'briefSummary': '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\n\nThe purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):\n\n(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives\n\nThis 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.\n\nThis a 3 steps study:\n\n1. 200 patients will be enrolled and answer a questionnaire on knowledge of the disease\n2. Two groups of 20 patients will be selected to participate to a semi-structured individual interviews\n3. Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with AMD (neovascular and atrophic) whatever the stage of the disease\n* Patient over 50\n* Patient affiliated to a social security scheme\n* Written informed consent of the patient\n\nExclusion Criteria:\n\n* Patient unable to understand the information, fill out the questionnaires\n* Patient with diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT03690505', 'acronym': 'DEMELE', 'briefTitle': 'Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place', 'orgStudyIdInfo': {'id': 'I16027/DEMELE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Assessment', 'description': 'Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place', 'interventionNames': ['Behavioral: Interviews']}], 'interventions': [{'name': 'Interviews', 'type': 'BEHAVIORAL', 'description': 'informant-based questionnaire semi-structured individual interviews focus group interviews', 'armGroupLabels': ['Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine DE SOUSA, Nurse', 'role': 'CONTACT', 'email': 'InInfirmieresConsultOphtalmo@chu-limoges.fr', 'phone': '05 55 05 64 79'}, {'name': 'Carine PEREZ', 'role': 'CONTACT', 'email': 'Carine.Perez@chu-limoges.fr', 'phone': '05 55 05 64 79'}], 'facility': "Service d'Ophtalmologie", 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'centralContacts': [{'name': 'Catherine Catherine DE SOUSA, Nurse', 'role': 'CONTACT', 'email': 'InfirmieresConsultOphtalmo@chu-limoges.fr', 'phone': '05 55 05 64 79'}, {'name': 'Catherine DE SOUSA', 'role': 'CONTACT', 'email': 'InfirmieresConsultOphtalmo@chu-limoges.fr', 'phone': '05 55 05 64 79'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}