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Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia

Primary Purpose

Mild Cognitive Impairment, Mild Dementia, Healthy Older Adults

Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Perceptual-based memory encoding
Semantic-based memory encoding
Cognitive stimulation
Sponsored by
University of Western Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring memory encoding, functional performance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Western Sydney University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Perceptual-based memory encoding

Semantic-based memory encoding

Cognitive stimulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Disability Assessment for Dementia - Change from baseline after the intervention
Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention

Secondary Outcome Measures

Color Trails Test - Change from baseline after the intervention
Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention
Behavior Rating Inventory of Executive Function - Change from baseline after the intervention

Full Information

First Posted
February 5, 2018
Last Updated
November 13, 2022
Sponsor
University of Western Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT03430401
Brief Title
Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To test the feasibility of conducting a newly developed computer-based cognitive rehabilitation program for healthy older adults, people with MCI and mild dementia. 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. Using an iPad application, study participants will learn a memory encoding strategy to support completion of their daily activities. By implementing memory encoding strategies during the mild stages of cognitive decline, the project aims to prolong independence in functional performance. It is anticipated that adoption of the same memory strategies will enable maintain performance as they may experience ongoing cognitive decline.
Detailed Description
This study extends on the positive results of a pilot study (Lim et al., 2012) which demonstrated the effectiveness of a cognitive training program combined with perceptual and semantic memory encoding strategies. Following the intervention phase of the pilot study, elements of cognition were examined using standardised assessments. The participants showed improved general attention (p = 0.03), memory (p = 0.03) and cognitive function including naming (p = 0.02), construction (p = 0.01), memory (p = 0.02) and similarities (p = 0.001) all of which are necessary for functioning in daily activities. However, due to the combination of strategies used during the pilot study, the isolated effect of perceptual and semantic memory encoding strategies could not be determined. It has been found that the effects of aging impact negatively on both semantic and perceptual encoding. However, with age, there tends to be a greater impact on an individual's ability to use perceptual encoding strategies in comparison to those of semantic (Kuo, Liu, Ting, & Chan, 2014). This varies in the case of individuals in the early stages of Alzheimer's disease in which many individuals will show progressive impairment in semantic memory (Hodges & Patterson, 1995). As dementia has been positively correlated with Mild Cognitive Impairment (MCI) but not often diagnosed until much later in the course of the disease and as not all individuals with MCI will progress to dementia it would be beneficial prior to undertaking a memory encoding intervention program to understand if an individual would benefit greater from undertaking a semantic or a perceptual memory encoding rehabilitation approach. Although it may be easy for a healthy adult to report their preference in encoding style, an individual with MCI or mild dementia may find this more difficult due to the abstract complexity of the concepts. As it is known that not all cases of MCI progress to dementia, this study aims at identifying if individuals with MCI or mild dementia will benefit from intervention based on both semantic and perceptual encoding styles. In addition, given the benefit and successful use of computer-based programs in elderly, this study will develop the memory encoding training program into a user-friendly computer-based program in healthy older adults, older adults with MCI or mild dementia will be able to use under the guidance of rehabilitation professionals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Dementia, Healthy Older Adults
Keywords
memory encoding, functional performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perceptual-based memory encoding
Arm Type
Experimental
Arm Description
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.
Arm Title
Semantic-based memory encoding
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Perceptual-based memory encoding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Semantic-based memory encoding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive stimulation
Intervention Description
The frequency, duration and the number of sessions will be consistent with the experimental interventions.
Primary Outcome Measure Information:
Title
Disability Assessment for Dementia - Change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Color Trails Test - Change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
Behavior Rating Inventory of Executive Function - Change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Selection Criteria for healthy older adults: Score greater than 24 on the Mini-Mental State Examination, 2nd edition, standard version (MMSE) Score less than 5 on the 15-item Geriatric Depression Scale - Short Form (GDS) No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria); and Are able to provide voluntary consent to participate in the study. Selection Criteria for people with MCI: No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria); Have a Clinical Dementia Rating Score (CDR) of 0 indicating no dementia; Meets the diagnostic criteria for MCI (Petersen, 2004); and Are able to provide voluntary consent to participate in the study. Selection Criteria for people with mild dementia: Have a diagnosis of probable dementia; Have a CDR score of 1 indicating mild dementia; Have a career or family members who are able to report functional performance; and Are able to provide voluntary consent to participate in the study, or have a guardian to provide consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen P.Y. Liu, PhD
Organizational Affiliation
Western Sydney University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Sydney University
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia

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