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

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ClinicalTrials.gov Identifier: NCT03430401
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Liu, University of Western Sydney

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


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Mild Dementia Behavioral: Perceptual-based memory encoding Behavioral: Semantic-based memory encoding Behavioral: Cognitive stimulation Not Applicable

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 which the older adults with MCI or mild dementia will be able to use under the guidance of rehabilitation professionals.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computer-based Cognitive Rehabilitation Program to Improve Cognition and Delay Deterioration in Functional Performance for Older People With Mild Cognitive Impairment and Mild Dementia
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Perceptual-based memory encoding
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

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.


Experimental: Semantic-based memory encoding
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

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.


Active Comparator: Cognitive stimulation
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
The frequency, duration and the number of sessions will be consistent with the experimental interventions.




Primary Outcome Measures :
  1. Disability Assessment for Dementia - Change from baseline after the intervention [ Time Frame: Baseline and after the intervention (12 weeks) ]
  2. 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 Measures :
  1. Color Trails Test - Change from baseline after the intervention [ Time Frame: Baseline and after the intervention (12 weeks) ]
  2. Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention [ Time Frame: Baseline and after the intervention (12 weeks) ]
  3. Behavior Rating Inventory of Executive Function - Change from baseline after the intervention [ Time Frame: Baseline and after the intervention (12 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 voluntarily 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 is able to report functional performance; and
  4. Are able to provide voluntarily consent to participate in the study, or have a guardian to provide consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430401


Contacts
Contact: Karen P.Y. Liu, PhD +61 2 4620 3432 karen.liu@westernsydney.edu.au
Contact: Nikki Tulliani n.tulliani@westernsydney.edu.au

Locations
Australia, New South Wales
Western Sydney University
Penrith, New South Wales, Australia, 2751
Sponsors and Collaborators
University of Western Sydney
Investigators
Principal Investigator: Karen P.Y. Liu, PhD Western Sydney University

Responsible Party: Karen Liu, Associate Professor, University of Western Sydney
ClinicalTrials.gov Identifier: NCT03430401     History of Changes
Other Study ID Numbers: UWesternSydney
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Liu, University of Western Sydney:
memory encoding
functional performance

Additional relevant MeSH terms:
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders