NCT02953964

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

5.4 years

First QC Date

September 21, 2016

Last Update Submit

November 1, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • Change in Cognistat

    Within two days before the intervention and within two days after the 10-week intervention

  • Change in Digit Span Test

    Within two days before the intervention and within two days after the 10-week intervention

  • Change in Consortium to Establish a Registry for Alzheimer's Disease

    Within two days before the intervention and within two days after the 10-week intervention

Study Arms (3)

Behavioral: perceptual-based memory encoding training

EXPERIMENTAL

Participants receive perceptual-based memory encoding training

Other: Behavioral: perceptual-based memory encoding training

Behavioral: Semantic-based memory encoding training

EXPERIMENTAL

Participants receive semantic-based memory encoding training

Other: Behavioral: semantic-based memory encoding training

Behavioral : control group

ACTIVE COMPARATOR

Participants receive cognitive stimulation intervention

Other: Behavioral: Cognitive stimulation group (control group)

Interventions

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: perceptual-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: Semantic-based memory encoding training

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.

Also known as: Cognitive stimulation group
Behavioral : control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Western Sydney University

Penrith, New South Wales, 2751, Australia

Location

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Mraz H, Tong CY, Liu KPY. Semantic-based memory-encoding strategy and cognitive stimulation in enhancing cognitive function and daily task performance for older adults with mild cognitive impairment: A pilot non-randomised cluster controlled trial. PLoS One. 2023 Mar 27;18(3):e0283449. doi: 10.1371/journal.pone.0283449. eCollection 2023.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2016

First Posted

November 3, 2016

Study Start

May 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations