- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07039708
- Original Trial
A Computer-based Memory Strategy Training Program for Older Adults
A Computer-based Memory Strategy Training Program to Promote Everyday Performance in Healthy Older Adults, Older Adults With Memory Complaints, Mild Cognitive Impairment and Mild Dementia
Study Overview
Status
Intervention / Treatment
Detailed Description
The objectives of the study are to investigate the feasibility and pilot-test the benefits of the computer-based E-MinD Life (Semantic) program to promote everyday performance in healthy older adults, older adults with memory complaints, mild cognitive impairment (MCI) and mild dementia in Hong Kong using a randomised control trial.
Three groups of participants will be recruited: (1) 15 healthy older adults, (2) 15 older adults aged over 65 years with memory complaints, or older adults aged over 65 years, meeting the diagnostic criteria for MCI with a Clinical Dementia Rating score of 0 or having mild dementia with a Clinical Dementia Rating score of 1. All participants will have no depression and other clinical conditions that may affect their cognition. Their scores on the Montreal Cognitive Assessment will be recorded. Their carers or family members are invited to participate.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen Liu
- Phone Number: +85227665386
- Email: karen.liu@polyu.edu.hk
Study Contact Backup
- Name: Karen Liu
- Email: karen.liu@polyu.edu.hk
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
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Contact:
- Karen Liu
- Phone Number: 85227665386
- Email: karen.liu@polyu.edu.hk
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Contact:
- Email: karen.liu@polyu.edu.hk
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Principal Investigator:
- Karen Liu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Group 1: healthy older adults aged 65 years or above Group 2: older adults aged 65 years or above with memory complaints Group 3: older adults aged 65 or above with mild cognitive impairment
Exclusion Criteria (for all groups 1, 2 and 3)
- have depression and other clinical conditions that may affect their cognition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: E-MinD Life Semantic
Participants receive the E-MinD Life (Semantic) programme.
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The E-MinD Life programme is designed to teach semantic memory strategies.
The memory strategies are applied to 12 common daily activities required for community living, e.g.
meal preparation, laundry activities, and built into the E-MinD Life programme on a computer-based platform.
The intervention runs over 9 weeks with one 45-minute individual face-to-face or online healthcare-professional-led session and two 30-minute, family-assisted home sessions per week.
During the home sessions, participants will complete the same activities as those learnt during the healthcare-professional-led sessions.
Family members or carers will be invited to join the healthcare-professional-led sessions as observers and support the participants in the home sessions if needed.
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Active Comparator: Cognitive stimulation
Participants will receive cognitive stimulation.
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Participants will receive stimulation for visual attention and memory through activities such as playing a game that requires them to find missing pieces, and auditory attention and memory through activities such as remembering a song.
The intervention will adopt a similar structure as the E-MinD Life Semantic group, with one 45-minute individual face-to-face or online healthcare-professional-led session and two 30-minute, family-assisted home sessions per week for 9 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accceptability
Time Frame: End of the intervention at 9 weeks
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Acceptability is measured using a structured questionnaire divided into five sections: (1) the therapist-led group sessions, (2) the self-administered individual sessions, and (3) the computer program interface and iPad usability, (4) the overall program design and structure and (5) overall satisfaction.
Participants are invited to give quantitative ratings on four dimensions under each section: (a) perceived effectiveness (e.g., whether the program improved cognitive strategy use), (b) relevance (e.g., how applicable the activities were to daily life), (c) convenience (e.g., ease) and (d) clarity.
Responses are collected using a 4-point Likert scale, ranging from 1 "Completely disagree" to 4 "Completely agree," with higher scores indicating greater acceptability.
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End of the intervention at 9 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility by measuring the attendance rate
Time Frame: Through the intervention for 9 weeks, attendance at each session
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Feasibility by measuring the intervention attendance rate
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Through the intervention for 9 weeks, attendance at each session
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Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
Time Frame: From enrollment to the end of intervention at 9 weeks
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The CERAD-NAB provides a profile on cognitive function by assessing cognitive deficits and was validated in a Chinese version.
This study will use all subtests, including Verbal Fluency (J1), Boston's Naming (J2), Mini-Mental State Examination (MMSE, J3), Word List Memory (J4), Constructional Praxis (J5), Word List Recall (J6), Word List Recognition (J7) and Recall of Constructional Praxis (J8).
The total score ranges from 0 -115 with a higher score indicating better performance.
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From enrollment to the end of intervention at 9 weeks
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Digit Span Test
Time Frame: From enrollment to the end of intervention at 9 weeks
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The Digit Span Test consists of Digit Span Forward (DSF) and Digit Span Backward (DSB), measures immediate verbal recall, attentional capacity and working memory.
The score is the number of digits in the longest successfully recalled sequence.
A higher score indicates a better performance.
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From enrollment to the end of intervention at 9 weeks
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Lawton Instrumental Activities of Daily Living Scale
Time Frame: From enrollment to the end of intervention at 9 weeks
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The self-reported Lawton Instrumental Activities of Daily Living Scale-Chinese version (IADLS) assesses one's ability to independently perform eight domains of instrumental daily activities such as meal preparation, laundry work, and shopping.
The scale consists of nine items, each rated on a 3-point or 4-point scale, with a total score ranging from 0 to 18 or higher.
A higher score indicates a better performance
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From enrollment to the end of intervention at 9 weeks
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Disability Assessment for Dementia (DAD)
Time Frame: From enrollment to the end of intervention at 9 weeks
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The Chinese version of the Disability Assessment for Dementia (DAD) is a survey, completed by a proxy/carer, that evaluates the level of independence in daily activities for a person who has dementia or cognitive impairment.
The DAD is scored based on a "yes/no" system, where "yes" indicates the person performed the activity without help, and "no" indicates they did not.
The number of "yes" responses is totalled, and then converted to a percentage score out of 100.
Higher percentage scores indicate better functional ability.
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From enrollment to the end of intervention at 9 weeks
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EuroQoL- 5 Dimensions - 5 Levels Hong Kong version (EQ-5D-5L_HK)
Time Frame: From enrollment to the end of intervention at 9 weeks
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The EQ-5D-5L HK measures health-related quality of life in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, using five rating levels (33).
The 5-level health status is converted to a utility value, ranging from 0 (death) to 1 (full health).
The EQ-5D-5L HK includes a Visual Analogue Scale where respondents rate their overall health on a scale of 0 to 100.
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From enrollment to the end of intervention at 9 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Karen Liu, The Hong Kong Polytechnic 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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HongKongPU_E-MinD Life Semanti
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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