NCT03430401

Brief Summary

This study will adopt a newly developed computer-based cognitive rehabilitation program targeting the encoding stage of memory. The aims of the study are:

  1. 1.To test the feasibility of conducting a newly developed computer-based cognitive rehabilitation program for healthy older adults, people with MCI and mild dementia.
  2. 2.To test the effectiveness of the newly developed program in improving cognitive function and enabling maintenance of occupational performance in healthy older adults, people with MCI or mild dementia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

7.1 years

First QC Date

February 5, 2018

Last Update Submit

May 7, 2024

Conditions

Keywords

memory encodingfunctional performance

Outcome Measures

Primary Outcomes (2)

  • Disability Assessment for Dementia - Change from baseline after the intervention

    Baseline and after the intervention (12 weeks)

  • Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention

    Baseline and after the intervention (12 weeks)

Secondary Outcomes (3)

  • Color Trails Test - Change from baseline after the intervention

    Baseline and after the intervention (12 weeks)

  • Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention

    Baseline and after the intervention (12 weeks)

  • Behavior Rating Inventory of Executive Function - Change from baseline after the intervention

    Baseline and after the intervention (12 weeks)

Study Arms (3)

Perceptual-based memory encoding

EXPERIMENTAL

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.

Behavioral: Perceptual-based memory encoding

Semantic-based memory encoding

EXPERIMENTAL

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.

Behavioral: Semantic-based memory encoding

Cognitive stimulation

ACTIVE COMPARATOR

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: Cognitive stimulation

Interventions

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.

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.

Semantic-based memory encoding

The frequency, duration and the number of sessions will be consistent with the experimental interventions.

Cognitive stimulation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
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.

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

Sponsors & Collaborators

Study Sites (1)

Western Sydney University

Penrith, New South Wales, 2751, Australia

Location

Related Publications (1)

  • Tulliani N, Bye R, Bissett M, Coutts S, Liu KPY. The feasibility and acceptability of an app-based cognitive strategy training programme for older people. Pilot Feasibility Stud. 2023 Jun 30;9(1):109. doi: 10.1186/s40814-023-01334-x.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Karen P.Y. Liu, PhD

    Western Sydney University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

August 1, 2018

Primary Completion

August 31, 2025

Study Completion

December 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations