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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02953964
Other study ID # Memory encoding
Secondary ID
Status Completed
Phase N/A
First received September 21, 2016
Last updated November 1, 2016
Start date May 2010
Est. completion date October 2015

Study information

Verified date November 2016
Source University of Western Sydney
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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


Description:

People with dementia experience a cognitive decline that affects their functional performance. It has been identified that encoding is less effective in people with dementia. Rehabilitating at the encoding stage is, therefore, essential. A recent systematic review found that effective interventions needed to include training in individually selected memory encoding strategies. These strategies are classified as either perceptual (visual) or semantic (association) memory encoding strategies.

Based on the above literature, the chief investigator (Associate Professor Karen Liu) ran a pilot study on an integrated home and community centre cognitive training programme for 20 elderly people with memory problem using a pre-test and post-test comparison design.

Extending on the positive results, the aim of this project was to investigate the effectiveness of perceptual and semantic encoding strategies (and compare with a control intervention). It also aims to promote the understanding of memory loss and dementia and the need for early intervention for family members of the participants.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
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.
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.
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.

Locations

Country Name City State
Australia Western Sydney University Penrith New South Wales
Hong Kong The Hong Kong Polytechnic University Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
University of Western Sydney

Countries where clinical trial is conducted

Australia,  Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Disability Assessment for Dementia Change in Disability Assessment for Dementia to assess assistance required in basic daily tasks such as dressing, bathing Within two days before the intervention and within two days after the 10-week intervention No
Primary Change in Instrumental Activities of Daily Living Scale Change in Instrumental Activities of Daily Living Scale to assess assistance required in instrumental daily tasks such as laundry, meal preparation Within two days before the intervention and within two days after the 10-week intervention No
Secondary Change in Cognistat Change in Cognistat to assess general cognitive function Within two days before the intervention and within two days after the 10-week intervention No
Secondary Change in Digit Span Test Change in Digit Span Test to assess attention and working memory Within two days before the intervention and within two days after the 10-week intervention No
Secondary Change in Consortium to Establish a Registry for Alzheimer's Disease Change in Consortium to Establish a Registry for Alzheimer's Disease to assess cognitive function in verbal fluency, memory Within two days before the intervention and within two days after the 10-week intervention No
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