Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-27 @ 5:03 AM
Study NCT ID:
NCT06520995
Status:
RECRUITING
Last Update Posted:
2024-07-25
First Post:
2024-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elderly Patients With Type 2 Diabetes and Cognitive Exercises
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2024-07-20', 'studyFirstSubmitQcDate': '2024-07-20', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurocognitive profile', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': 'Neurocognitive Assessment Battery'}], 'secondaryOutcomes': [{'measure': 'Hba1c', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': "Laboratory values derived from patients' routine visits"}, {'measure': 'Psychological state', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': 'A Scale to assess psychological state'}, {'measure': 'Quality of Life (1)', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': 'Burden of Diabetes in the Elderly Scale'}, {'measure': 'Quality of Life (2)', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': 'Type 2 Diabetes Self-Management Scale'}, {'measure': 'Qality of Life (3)', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': 'SF-12 Quality of Life Scale'}, {'measure': 'Cognitive Function (2)', 'timeFrame': 'The moment it is included in the study, 3rd month, 6th month', 'description': 'Cognitive Function Instrument-Participant Form'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment', 'Diabetes Mellitus, Type 2', 'Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'The study was planned as a single-center, prospective randomized controlled study. Individuals over 65 years of age with type 2 diabetes without severe cognitive impairment will be included in the study. The primary aim of the study is to improve the cognitive functions of the patients after the interventions. The secondary aim is to strengthen patients\' diabetes self-management and increase their quality of life, especially by improving their glycemic control. For these purposes, in our study, patients will be randomized into three groups: "cognitive exercise and diabetes education", "diabetes education only" and "control" group. The control group will be provided with standard outpatient diabetes education. Individuals who will be in the "cognitive exercise and video training" group will watch a total of 12 diabetes education videos prepared by the researcher, in which a different topic will be discussed every week for 3 months, and they will also participate cognitive exercises for 15-20 minutes a day for 3 months via a mobile application. Individuals in the "diabetes education only" group will similarly watch a total of 12 diabetes education videos prepared by the researchers. Patients will be evaluated in terms of cognitive function, psychosocial problems (anxiety, depression, stress), glycemic control (HbA1c), diabetes management and quality of life before the interventions, at 3 months and 6 months.', 'detailedDescription': 'The aim of this study is to strengthen patient outcomes and diabetes management in individuals with diabetes through cognitive-based diabetes education. The study was planned as a single-center, prospective randomized controlled study. İndividuals over 65 years of age with type 2 diabetes with without severe cognitive impairment will be included in the study. In the study, patients will receive diabetes education and cognitive exercise for 12 weeks. In the study, patients will be randomized into three groups: "cognitive exercise and diabetes education", "diabetes education only" and "control" group. The control group will be provided with standard outpatient diabetes education. Patients will be evaluated in terms of cognitive function, psychosocial problems (anxiety, depression, stress), glycemic control (HbA1c), diabetes management and quality of life before the interventions, at 3 months and 6 months.\n\nIn the study, diabetes education will be provided through short, understandable diabetes education videos prepared by the researcher with up-to-date guide information. A total of 12 videos will be sent to patients\' phones, covering a different topic each week for 3 months. Diabetes education video contents are as follows; Type 2 diabetes definition, symptoms and the effect of diabetes on cognitive functions, Medical nutrition therapy and healthy nutrition recommendations in Type 2 diabetes, The importance of diabetes and exercise, Oral antidiabetic treatments, Insulin treatment, Hypoglycemia symptoms, findings and treatment, Macrovascular complications in diabetes, Microvascular complications in diabetes, Foot Protection and care recommendations, Diabetes self-care skills and problem-solving strategies, Diabetes and stress management.\n\nA mobile application will be used as a cognitive exercise tool in the study. This mobile application is a science-based application that patients can access via their smartphone or tablet. It consists of verbal, numerical, visual, logical, memory and attention categories and contains 24 different gamified mind exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes for at least one year\n* Literate\n* Able to use smartphone/tablet/computer and have internet access\n* Individuals who agree to participate in the study will be included.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* With severe cognitive impairment\n* Known neurological or psychiatric disorders\n* Severely depressed\n* Individuals with disabilities (vision, hearing problems, etc.) will not be included in the study'}, 'identificationModule': {'nctId': 'NCT06520995', 'acronym': 'DIACOG', 'briefTitle': 'Elderly Patients With Type 2 Diabetes and Cognitive Exercises', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Education Program Supported by Cognitive Exercises in Elderly Individuals With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2023/183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients in this group will only receive standard diabetes education.'}, {'type': 'EXPERIMENTAL', 'label': 'Video Group', 'description': 'In addition to standard diabetes education, patients in this group will be educated with the mentioned video education program (a total of 12 diabetes education videos prepared by the researcher).', 'interventionNames': ['Other: Educational video program']}, {'type': 'EXPERIMENTAL', 'label': 'Video and Mobile application Group', 'description': 'In addition to standard diabetes education and video education, patients in this group will participate in cognitive exercises for 15-20 minutes a day for 3 months via a mobile application.', 'interventionNames': ['Other: Educational video program', 'Other: A mobile application']}], 'interventions': [{'name': 'Educational video program', 'type': 'OTHER', 'description': 'Diabetes education video contents are as follows; Type 2 diabetes definition, symptoms and the effect of diabetes on cognitive functions, Medical nutrition therapy and healthy nutrition recommendations in Type 2 diabetes, The importance of diabetes and exercise, Oral antidiabetic treatments, Insulin treatment, Hypoglycemia symptoms, findings and treatment, Macrovascular complications in diabetes, Microvascular complications in diabetes, Foot Protection and care recommendations, Diabetes self-care skills and problem-solving strategies, Diabetes and stress management.', 'armGroupLabels': ['Video Group', 'Video and Mobile application Group']}, {'name': 'A mobile application', 'type': 'OTHER', 'description': 'This mobile application is a science-based application that patients can access via their smartphone or tablet. It consists of verbal, numerical, visual, logical, memory and attention categories and contains 24 different gamified mind exercises', 'armGroupLabels': ['Video and Mobile application Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34320', 'city': 'Istanbul', 'state': 'Avcılar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hande Bulut Canbaz, MSc', 'role': 'CONTACT', 'email': 'habulut@ku.edu.tr', 'phone': '00905426686310'}, {'name': 'Zeliha Tulek, Prof.Dr.', 'role': 'CONTACT', 'email': 'ztulek@iuc.edu.tr', 'phone': '902122244986', 'phoneExt': '27254'}, {'name': 'Hande Bulut Canbaz, Msc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zeliha Tulek, Prof.Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Hande Bulut Canbaz, RN,Msc', 'role': 'CONTACT', 'email': 'habulut@ku.edu.tr', 'phone': '00905426686310'}, {'name': 'Zeliha Tulek, RN,Prof.Dr.', 'role': 'CONTACT', 'email': 'ztulek@iuc.edu.tr', 'phone': '00902122244986', 'phoneExt': '27254'}], 'overallOfficials': [{'name': 'Zeliha Tulek, RN,Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing'}, {'name': 'Hande Bulut Canbaz, RN,Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, Msc', 'investigatorFullName': 'Hande Bulut Canbaz', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}