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

• ClinicalTrials.gov Identifier: NCT03430401
• Recruitment Status: Active, not recruiting
• First Posted: February 12, 2018
• Last Update Posted: October 6, 2021
• Sponsor: University of Western Sydney
• Information provided by (Responsible Party): Karen Liu, University of Western Sydney

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:

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 Design

• 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
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: July 1, 2023

Arms and Interventions

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.

Outcome Measures

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) ]

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

• Responsible Party: Karen Liu, Associate Professor, University of Western Sydney
• ClinicalTrials.gov Identifier: NCT03430401
• Other Study ID Numbers: UWesternSydney
• First Posted: February 12, 2018
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

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