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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02953964




Registration number
NCT02953964
Ethics application status
Date submitted
21/09/2016
Date registered
3/11/2016
Date last updated
3/11/2016

Titles & IDs
Public title
Memory Encoding Strategies for People With Mild Cognitive Impairments
Scientific title
Perceptual and Semantic Memory Encoding Strategies for People With Mild Cognitive Impairment
Secondary ID [1] 0 0
Memory encoding
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
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Behavioral: perceptual-based memory encoding training
Other interventions - Behavioral: semantic-based memory encoding training
Other interventions - Behavioral: Cognitive stimulation group (control group)

Experimental: Behavioral: perceptual-based memory encoding training - Participants receive perceptual-based memory encoding training

Experimental: Behavioral: Semantic-based memory encoding training - Participants receive semantic-based memory encoding training

Active Comparator: Behavioral : control group - Participants receive cognitive stimulation intervention


Other interventions: Behavioral: perceptual-based memory encoding training
Participants are trained in the use of perceptual-based memory encoding strategies, inclusive of visual imagery and the method of loci. Visual imagery involves the creation and encoding of mental images, while the method of loci refers to linking these images with specific places to facilitate memory (Simon et al., 2012). Participants are taught to visualise performing each step of a task in a familiar environment, such as in their home (Liu et al., 2009). After participants can correctly visualise the entire task, they then progress to actually performing the task. During the intervention sessions, 2-3 tasks are covered each session, and these tasks become progressively difficult as the weeks progress. The intervention lasts for 10 weeks with one session every week. Each session runs for 90 minutes. A follow-up home training program is run once a week for 30 minutes with the participant and their care-giver.

Other interventions: Behavioral: semantic-based memory encoding training
Participants are asked to encode the steps of a task by forming an association of the steps and sequence. Participants are trained in the use of the chunking association method and honeycomb concept and perform different tasks each week, implementing this encoding strategy (Lim et al., 2012). The chunking association method breaks down information into smaller parts and helps with the encoding and retrieval of information. The honeycomb concept allows the steps to form a story in relation to place, time, characters, problem and solution and the story is verbalised. Participants then complete the task. During the intervention sessions, 2-3 tasks are covered each session, and these tasks become progressively difficult as the weeks progress. The intervention lasts for 10 weeks with one session every week. Each session runs for 90 minutes. A follow-up home training program is run once a week for 30 minutes with the participant and their care-giver.

Other interventions: Behavioral: Cognitive stimulation group (control group)
Participants receiving cognitive stimulation intervention. It consists of eight sessions that train participants' visual attention and memory, auditory attention and memory and their application in daily activities. Two sessions are also given which allow for participants to apply the training practically in their daily lives. The intervention lasts for 10 weeks with one session every week. Each session runs for 90 minutes. A follow-up home training program is run once a week for 30 minutes with the participant and their care-giver.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Disability Assessment for Dementia
Timepoint [1] 0 0
Within two days before the intervention and within two days after the 10-week intervention
Primary outcome [2] 0 0
Change in Instrumental Activities of Daily Living Scale
Timepoint [2] 0 0
Within two days before the intervention and within two days after the 10-week intervention
Secondary outcome [1] 0 0
Change in Cognistat
Timepoint [1] 0 0
Within two days before the intervention and within two days after the 10-week intervention
Secondary outcome [2] 0 0
Change in Digit Span Test
Timepoint [2] 0 0
Within two days before the intervention and within two days after the 10-week intervention
Secondary outcome [3] 0 0
Change in Consortium to Establish a Registry for Alzheimer's Disease
Timepoint [3] 0 0
Within two days before the intervention and within two days after the 10-week intervention

Eligibility
Key inclusion criteria
Selection Criteria:

- are aged 60 or above;

- have no previous psychiatric or memory disorder history or other neurological illness;

- have Mini-mental State Examination score (MMSE) greater than or equal to 21;

- have Clinical Dementia Rating score (CDR) of 0.5 or 1 indicating very mild and mild
dementia;

- do not show sign of depression with score below 9 out of 30 in the Geriatric
Depression Scale;

- are able to communicate effectively;

- have family member who can participate in the study; and

- voluntarily consent to participate in the study.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Western Sydney University - Penrith
Recruitment postcode(s) [1] 0 0
2751 - Penrith
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong

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

Ethics approval
Ethics application status

Summary
Brief summary
The purposes of the study are:

- To evaluate the effectiveness of a perceptual-based training program in enhancing
cognitive and everyday functioning of older adults with mild cognitive impairment and
mild dementia

- To evaluate the effectiveness of a semantic-based training program in enhancing
cognitive and everyday functioning of older adults with mild cognitive impairment and
mild dementia
Trial website
https://clinicaltrials.gov/ct2/show/NCT02953964
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02953964