Mild Cognitive ImpairmentNCT02953964
Memory Encoding Strategies for People With Mild Cognitive Impairments
A study testing Behavioral: perceptual-based memory encoding training and Behavioral: semantic-based memory encoding training in people with Mild Cognitive Impairment and Mild Dementia, run by University of Western Sydney at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia
- What is being tested?
- Behavioral: perceptual-based memory encoding training and Behavioral: semantic-based memory encoding training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2010to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Perceptual and Semantic Memory Encoding Strategies for People With Mild Cognitive Impairment
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
Read the detailed description
People with dementia experience a cognitive decline that affects their functional performance. It has been identified that encoding is less effective in people with dementia. Rehabilitating at the encoding stage is, therefore, essential. A recent systematic review found that effective interventions needed to include training in individually selected memory encoding strategies. These strategies are classified as either perceptual (visual) or semantic (association) memory encoding strategies.
Based on the above literature, the chief investigator (Associate Professor Karen Liu) ran a pilot study on an integrated home and community centre cognitive training programme for 20 elderly people with memory problem using a pre-test and post-test comparison design.
Extending on the positive results, the aim of this project was to investigate the effectiveness of perceptual and semantic encoding strategies (and compare with a control intervention). It also aims to promote the understanding of memory loss and dementia and the need for early intervention for family members of the participants.
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Being tested
- Behavioral: perceptual-based memory encoding training, Behavioral: semantic-based memory encoding training, Behavioral: Cognitive stimulation group (control group)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: perceptual-based memory encoding trainingOther
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: semantic-based memory encoding trainingOther
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: Cognitive stimulation group (control group)Other
Also called Cognitive stimulation group
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: perceptual-based memory encoding training | Experimental | Participants receive perceptual-based memory encoding training Receives: Other: Behavioral: perceptual-based memory encoding training |
| Behavioral: Semantic-based memory encoding training | Experimental | Participants receive semantic-based memory encoding training Receives: Other: Behavioral: semantic-based memory encoding training |
| Behavioral : control group | Active comparator | Participants receive cognitive stimulation intervention Receives: Other: Behavioral: Cognitive stimulation group (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability Assessment for Dementia
Change in Disability Assessment for Dementia to assess assistance required in basic daily tasks such as dressing, bathing
Measured: 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
Measured: Within two days before the intervention and within two days after the 10-week intervention
Secondary outcomes (3)
Change in Cognistat
Change in Cognistat to assess general cognitive function
Measured: Within two days before the intervention and within two days after the 10-week intervention
Change in Digit Span Test
Change in Digit Span Test to assess attention and working memory
Measured: 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
Change in Consortium to Establish a Registry for Alzheimer's Disease to assess cognitive function in verbal fluency, memory
Measured: Within two days before the intervention and within two days after the 10-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startMay 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Liu, University of Western Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953964
- Sponsor's protocol ID
- Memory encoding
- Status last verified
- Nov 2016
- First submitted
- 21 Sep 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36972279
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual and Semantic Memory Encoding Strategies for People With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02953964
- Acronym / sponsor ID
- Memory encoding
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
People with dementia experience a cognitive decline that affects their functional performance. It has been identified that encoding is less effective in people with dementia. Rehabilitating at the encoding stage is, therefore, essential. A recent systematic review found that effective interventions needed to include training in individually selected memory encoding strategies. These strategies are classified as either perceptual (visual) or semantic (association) memory encoding strategies.
Based on the above literature, the chief investigator (Associate Professor Karen Liu) ran a pilot study on an integrated home and community centre cognitive training programme for 20 elderly people with memory problem using a pre-test and post-test comparison design.
Extending on the positive results, the aim of this project was to investigate the effectiveness of perceptual and semantic encoding strategies (and compare with a control intervention). It also aims to promote the understanding of memory loss and dementia and the need for early intervention for family members of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral: perceptual-based memory encoding training | Experimental | Other: Behavioral: perceptual-based memory encoding trainingParticipants receive perceptual-based memory encoding training |
| Behavioral: Semantic-based memory encoding training | Experimental | Other: Behavioral: semantic-based memory encoding trainingParticipants receive semantic-based memory encoding training |
| Behavioral : control group | Active comparator | Other: Behavioral: Cognitive stimulation group (control group)Participants receive cognitive stimulation intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: perceptual-based memory encoding trainingParticipants 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. | Other | Behavioral: perceptual-based memory encoding training |
| Behavioral: semantic-based memory encoding trainingParticipants 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. | Other | Behavioral: Semantic-based memory encoding training |
| Behavioral: Cognitive stimulation group (control group)Also: Cognitive stimulation groupParticipants 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. | Other | Behavioral : control group |
Primary outcome
Change in Disability Assessment for Dementia
Time frame: Within two days before the intervention and within two days after the 10-week intervention
Change in Disability Assessment for Dementia to assess assistance required in basic daily tasks such as dressing, bathing
Change in Instrumental Activities of Daily Living Scale
Time frame: Within two days before the intervention and within two days after the 10-week intervention
Change in Instrumental Activities of Daily Living Scale to assess assistance required in instrumental daily tasks such as laundry, meal preparation
3 secondary outcomes
Change in Cognistat
Time frame: Within two days before the intervention and within two days after the 10-week intervention
Change in Digit Span Test
Time frame: 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
Time frame: Within two days before the intervention and within two days after the 10-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Derived from this study: PubMed 36972279Mraz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: perceptual-based memory encoding training and Behavioral: semantic-based memory encoding training in people with Mild Cognitive Impairment and Mild Dementia, run by University of Western Sydney at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disability Assessment for Dementia (time frame: Within two days before the intervention and within two days after the 10-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.