- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06378606
Effect of Technology on Cognitive Function in Elderly (cogntion)
Effect of Screen Based Cognitove Therapy on Mild Dementi in Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 .
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: nourhan hisham ali
- Phone Number: 01156860154
- Email: nourheshame854@gmail.com
Study Contact Backup
- Name: kareem adel mohamed
- Phone Number: 01068908618
- Email: Adelkareem302@gmail.com
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 12511
- Recruiting
- Nour Ali
-
Contact:
- Nour Ali, master
- Phone Number: 01156860154
- Email: nourheshame854@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
1- 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
- Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months.
- Alzheimer's disease.
- Sever cognitive dementia.
- Sever hearing difficulty or visual disturbance.
- Brain injury.
- Limitation in communications.
- Chronic kidney diseases.
- Liver diseases.
- Low or high educated.
- Uncontrolled diabetic patients.
- Thyroid disturbance.
- Mental and psychological instability .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group A
(Therapy group) It will include subjects that will receive computer based cognitive therapy sessions training. omega 3 supplement . |
intervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement . group B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only.
Other Names:
|
|
Experimental: Group B
(Smartphone group) It will include subjects that will receive home program training by using their smartphones cognitive applications . omega 3 supplement . |
intervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement . group B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only.
Other Names:
|
|
Placebo Comparator: group c
It won't receive interventions.
only omega 3 supplement
|
intervention : group A: recive computer cognitive traing by rehacom system and omega 3 supplement . group B: recive smart phone cognitive application and omega 3 supplement . group c recive omega 3 supplement only.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive functions assessment
Time Frame: 1 year
|
Cognitive function : It 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. Montreal 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 |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life survey
Time Frame: 1 year
|
Quality of life : it was assessed by SF-12 health survey quality of life questionnaire. The 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) |
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: ahmed mahdi ahmed, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004907
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Impairment
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
University of EdinburghNHS LothianNot yet recruitingCognitive Impairment | Anesthesia | Cognitive Impairment, Mild | Anesthesia Brain Monitoring | Cognitive Impairment, Progressive | Anesthesia Depth MonitoringUnited Kingdom
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaRecruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive ImpairmentSpain
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
Sunnybrook Health Sciences CentreRecruitingMild Cognitive Impairment | Vascular Cognitive ImpairmentCanada
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University of HawaiiRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
Clinical Trials on cognitive therapy
-
Henry M. Jackson Foundation for the Advancement...National Alliance for Research on Schizophrenia and DepressionCompletedSuicide, AttemptedUnited States
-
Henry M. Jackson Foundation for the Advancement...Congressionally Directed Medical Research ProgramsCompletedSuicide, AttemptedUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
University of BergenCompleted
-
University of MalayaCompletedCognitive Impairment | Mild Traumatic Brain InjuryMalaysia
-
Laval UniversityUniversity of California, BerkeleyCompleted
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of WashingtonNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
Palo Alto Veterans Institute for ResearchNational Institute of Mental Health (NIMH)Active, not recruitingMobile Application-Based CBT Worksheet Collection | Paper-Based Worksheet CollectionUnited States
-
VU University of AmsterdamCompletedMajor Depressive DisorderNetherlands