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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03430401




Registration number
NCT03430401
Ethics application status
Date submitted
5/02/2018
Date registered
12/02/2018

Titles & IDs
Public title
Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
Scientific title
Computer-based Cognitive Rehabilitation Program to Improve Cognition and Delay Deterioration in Functional Performance for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
Secondary ID [1] 0 0
UWesternSydney
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 0 0
Mild Dementia 0 0
Healthy Older Adults 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Perceptual-based memory encoding
BEHAVIORAL - Semantic-based memory encoding
BEHAVIORAL - Cognitive stimulation

Experimental: Perceptual-based memory encoding - It will involve the use of visual imagery and the method of loci. To achieve this, each of the 15 daily tasks will be filmed and a short video created. In addition, each task will be broken down into 5-6 photographed steps based on activity analysis and task breakdown. The program will prompt the user to indicate in which room of the house the task would usually be completed. Once correct location is identified, the program will prompt the user to watch a chosen daily task video and then visualise themselves completing the task in their home environment.

Experimental: Semantic-based memory encoding - It will incorporate association-based strategies to assist with recalling the steps of daily tasks. The steps of a given daily task will be provided and the user will be prompted to link the steps using a honeycomb concept, which makes use of the chunking method to encode the sequenced steps. Following this, the program will prompt the user to categorise the steps according to their association with given words cues. The word cues will represent time, places, objects, and people. The program will then take the user response and form a verbal and visual story according to the responses given. The program will help identify any problems in the sequencing and prompt the user to re-categorise if required.

Active comparator: Cognitive stimulation - Participants will complete an online cognitive exercise program, Lumosity (Sarkar, Scanlon, \& Drescher, 2007). A study conducted by Hardy, Drescher, Sarkar, Kellett, and Scanlon (2011) indicated that participants who engaged in Lumosity showed greater improvements in memory in comparison to a non-intervention control group.


BEHAVIORAL: Perceptual-based memory encoding
It will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional.

In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention.

BEHAVIORAL: Semantic-based memory encoding
It will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional.

In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention.

BEHAVIORAL: Cognitive stimulation
The frequency, duration and the number of sessions will be consistent with the experimental interventions.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disability Assessment for Dementia - Change from baseline after the intervention
Timepoint [1] 0 0
Baseline and after the intervention (12 weeks)
Primary outcome [2] 0 0
Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention
Timepoint [2] 0 0
Baseline and after the intervention (12 weeks)
Secondary outcome [1] 0 0
Color Trails Test - Change from baseline after the intervention
Timepoint [1] 0 0
Baseline and after the intervention (12 weeks)
Secondary outcome [2] 0 0
Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention
Timepoint [2] 0 0
Baseline and after the intervention (12 weeks)
Secondary outcome [3] 0 0
Behavior Rating Inventory of Executive Function - Change from baseline after the intervention
Timepoint [3] 0 0
Baseline and after the intervention (12 weeks)

Eligibility
Key inclusion criteria
Selection Criteria for healthy older adults:

1. Score greater than 24 on the Mini-Mental State Examination, 2nd edition, standard version (MMSE)
2. Score less than 5 on the 15-item Geriatric Depression Scale - Short Form (GDS)
3. No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria); and
4. Are able to provide voluntary consent to participate in the study.

Selection Criteria for people with MCI:

1. No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria);
2. Have a Clinical Dementia Rating Score (CDR) of 0 indicating no dementia;
3. Meets the diagnostic criteria for MCI (Petersen, 2004); and
4. Are able to provide voluntary consent to participate in the study.

Selection Criteria for people with mild dementia:

1. Have a diagnosis of probable dementia;
2. Have a CDR score of 1 indicating mild dementia;
3. Have a career or family members who are able to report functional performance; and
4. Are able to provide voluntary consent to participate in the study, or have a guardian to provide consent.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Western Sydney University - Penrith
Recruitment postcode(s) [1] 0 0
2751 - Penrith

Funding & Sponsors
Primary sponsor type
Other
Name
University of Western Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karen P.Y. Liu, PhD
Address 0 0
Western Sydney University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03430401