Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 9:24 PM
Study NCT ID:
NCT06378606
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Technology on Cognitive Function in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly .'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-02-25', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive functions assessment', 'timeFrame': '1 year', 'description': 'Cognitive function :\n\nIt was assessed by rehacom software and Montreal cognitive assessment (MoCA) which are a highly sensitive and specific screening tool for patients with impaired cognitive function. 1- Rehacom software screening: 9 screening modules detect cognitive functions: 4Attention, 2memory, 1logical reasoning and 2 visual field.\n\nMontreal test is a short in duration (10- 15 min) 30-point screening test that measures a number of cognitive domains such as visuospatial abilities, executive function, short-term memory, attention/concentration, language, abstract thinking, and orientation. . Patients with MoCA scores of less than 26 are considered cognitively impaired Arabic version was used'}], 'secondaryOutcomes': [{'measure': 'Quality of life survey', 'timeFrame': '1 year', 'description': 'Quality of life : it was assessed by SF-12 health survey quality of life questionnaire.\n\nThe SF-12 is a generic, standardized questionnaire used to meas- ure two components of HRQoL: physical and mental health. . It is a shorter, yet valid alternative to the most widely used health status scale: the Short-Form-36 Health Survey Questionnaire (SF-36). The SF-12 reproduces the physical and mental component summary scores (PCS/MCS) of the SF-36. In addition, as the SF-12 contains fewer questions and takes less time to complete than the SF-36, it is more appropriate for use with older adults with common geriatric diseases, such as dementia .There scores range from zero (lowest HRQoL)-100 (highest)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.', 'detailedDescription': 'Aging over 60 years is associated with some progressive decline in cognitive domains, such as processing speed and executive function. A significant decline in cognitive function, particularly memory, which is an early symptom of dementia, can lead to mild cognitive impairment (MCI). Currently it is estimated that 50 million are living with dementia worldwide and nearly 10 million new cases occur every year, representing a serious public health problem. As such, the WHO has suggested that preventing cognitive decline and dementia is a global mental health priority. In addition to impacting the patient, dementia also has a significant impact on the family and society in general. Age is the biggest risk factor for the development of dementia, and aging is associated with a decline of cognitive function. Non-pharmacological interventions such as physical exercise and cognitive interventions may offer an alternative to pharmacological intervention in delaying dementia-related functional decline. Over the last decade, the accessibility and use of computers, smartphones and mobile internet has quickly expanded .\n\nCognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria\n\n1- Age ≥ 65 years. 2- Literate with ≥ 15 years of education. 3- Older adults with mild dementia. 4- Montreal cognitive assessment score 18-26 .( Pinto et al .,2019). 5- Android smartphone user. 6- Well ability to write and read. Exclusion criteria\n\n1. Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months.\n2. Alzheimer's disease.\n3. Sever cognitive dementia.\n4. Sever hearing difficulty or visual disturbance.\n5. Brain injury.\n6. Limitation in communications.\n7. Chronic kidney diseases.\n8. Liver diseases.\n9. Low or high educated.\n10. Uncontrolled diabetic patients.\n11. Thyroid disturbance.\n12. Mental and psychological instability ."}, 'identificationModule': {'nctId': 'NCT06378606', 'acronym': 'cogntion', 'briefTitle': 'Effect of Technology on Cognitive Function in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Screen Based Cognitove Therapy on Mild Dementi in Elderly', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': '(Therapy group) It will include subjects that will receive computer based cognitive therapy sessions training.\n\nomega 3 supplement .', 'interventionNames': ['Behavioral: cognitive therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': '(Smartphone group) It will include subjects that will receive home program training by using their smartphones cognitive applications .\n\nomega 3 supplement .', 'interventionNames': ['Behavioral: cognitive therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group c', 'description': "It won't receive interventions. only omega 3 supplement", 'interventionNames': ['Behavioral: cognitive therapy']}], 'interventions': [{'name': 'cognitive therapy', 'type': 'BEHAVIORAL', 'otherNames': ['cognitive training'], 'description': 'intervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement .\n\ngroup B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only.', 'armGroupLabels': ['Group B', 'group A', 'group c']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nour Ali, master', 'role': 'CONTACT', 'email': 'nourheshame854@gmail.com', 'phone': '01156860154'}], 'facility': 'Nour Ali'}], 'centralContacts': [{'name': 'nourhan hisham ali', 'role': 'CONTACT', 'email': 'nourheshame854@gmail.com', 'phone': '01156860154'}, {'name': 'kareem adel mohamed', 'role': 'CONTACT', 'email': 'Adelkareem302@gmail.com', 'phone': '01068908618'}], 'overallOfficials': [{'name': 'ahmed mahdi ahmed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan Hesham Ali', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physiotherapist /Nourhan Hisham Ali', 'investigatorFullName': 'Nourhan Hesham Ali', 'investigatorAffiliation': 'Cairo University'}}}}