Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT05427994
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2022-06-18', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life of AMD patients', 'timeFrame': 'at the recruitment to the study', 'description': 'Vision related Quality of life (QOL) of AMD patients related to vision assessed by NEI-VFQ-25 total score at the recruitment. NEI-VFQ-25 has 38 questions with multiple choice answers, each rated 0,25, 50, 75 or 100. The overall score is measured as a mean of all answers'}], 'secondaryOutcomes': [{'measure': 'Social Support', 'timeFrame': 'at the recruitment to the study', 'description': 'Percentage of AMD patients with Social Support. Social Support of AMD patients at the recruitment assessed by answering a yes/no question.'}, {'measure': 'Reliability of Social Support', 'timeFrame': 'at the recruitment to the study', 'description': 'Percentage of AMD patients with a reliable Social Support. Reliability of Social Support of AMD patients at the recruitment assessed by answering a yes/no question.'}, {'measure': 'Relationship between QOL and social support', 'timeFrame': 'at the recruitment to the study', 'description': "Correlation between the overall quality of life of AMD patients and demographic, visual characteristics, and social support tested with multiple linear regression model. The Hosmer-Lemeshow goodness-of-fit test will be used to test the model's fit. All tests will be two-tailed with a significance level of 0.05."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['age-related macular degeneration', 'quality of life', 'social support', 'reliability of social support', 'vision related quality of life'], 'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '36533748', 'type': 'DERIVED', 'citation': 'Ismayilova I, Turdaliyeva B, Aldasheva N, Veselovskaya N. Assessing the quality of life in age-related macular degeneration patients: a cross-sectional study in Kazakhstan. Acta Biomed. 2022 Dec 16;93(6):e2022299. doi: 10.23750/abm.v93i6.13580.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.", 'detailedDescription': "Background and study aims. Age-related macular degeneration (AMD) is the most prevalent chronic progressive ocular disease. It has been shown in several studies that AMD affects the quality of life of patients. The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.\n\nWho can participate? Patients with AMD, who wish to participate, will be recruited. Patients will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.\n\nWhat does the study involve? The study involves collecting demographic data of the participants, collecting baseline visual testing data from medical records, filling out of the NEI-VFQ-25, and answering two yes/no questions related to the social support and reliability of social support.\n\nWhat are possible benefits and risks of participating? Assessment of quality of life and social support of the AMD patients is a first step of developing targeted psycho-social support programs for AMD patients.\n\nWhere is the study run from? Patients will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.\n\nWhen is the study starting and how long it is expected to run for? Start date 03/02/2020. End date 27/08/2022.\n\nWho is funding the study? No funding for this study. Who is the main contact? Principal investigator: Inara Ismailova; +380 73 200 0688; i.ismayilova@gmail.com"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosed age-related macular degeneration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age-related macular degeneration; ability to speak and understand Russian and/or Kazakh language; willingness to participate\n\nExclusion Criteria:\n\n* Presence of glaucoma, cataracts of grade 2 or more according to the Lens Opacities Classification System (LOCS) III, and the presence of corneal opacities or any other retinal diseases'}, 'identificationModule': {'nctId': 'NCT05427994', 'briefTitle': 'Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients', 'organization': {'class': 'OTHER', 'fullName': 'Asfendiyarov Kazakh National Medical University'}, 'officialTitle': 'Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients', 'orgStudyIdInfo': {'id': '1394'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with age-related macular degeneration', 'description': 'Patients with age-related macular degeneration who fill out the quality of life questionnaire, and answer questions about social support and reliability of social support', 'interventionNames': ['Other: National Eye Institute Visual Function Questionnaire']}], 'interventions': [{'name': 'National Eye Institute Visual Function Questionnaire', 'type': 'OTHER', 'otherNames': ['NEI-VFQ-25'], 'description': 'National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) measures the quality of life related to vision. This questionnaire has been validated for use on low vision patients.', 'armGroupLabels': ['Patients with age-related macular degeneration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050012', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Kazakh Scientific - Research Institute of Eye Diseases', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': "Medical Centre Hospital of President'S Affairs Administration of the Republic of Kazakhstan", 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}], 'overallOfficials': [{'name': 'Inara Isamyilova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asfendiyarov Kazakh National Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'According to the patient consent form data is not available for scientific use by others than the project group members.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asfendiyarov Kazakh National Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ildar Fakhradiyev', 'investigatorAffiliation': 'Asfendiyarov Kazakh National Medical University'}}}}