Plain English Summary
Background and study aims
An area of research called "mnemic neglect" has shown that when given information that in some way threatens our self-concept (our own view of ourselves), we tend to remember less of this information later on. If we are told exactly the same information, but asked to imagine that it applies to someone else called "Chris", then we tend to remember more about it. These findings suggest that the amount of information that we remember often depends on the extent to which this information, then we can help them to remember more about it. This study will look at how mnemic neglect operates amongst people with dementia using research techniques which have already been used to study the phenomenon in people without dementia. If the findings are similar then we may be able to find better ways of talking to people with dementia about their illness.
Who can participate?
Patients with a diagnosis of Alzheimer's Disease, Vascular Dementia or a mixed form of these from memory clinics from three sites in South West England
What does the study involve?
Participants are asked to carry out a number of memory tests to examine:
Study A - recall of neutral versus illness related words
Study B - recall of negative and positive behavioural statements
Study C - recall of statements related to dementia
Participants taking part in in studies B and C are randomly allocated to one of two groups. Those in group 1 are asked to imagine the statements as “applies to yourself". Those in group 2 are asked to imagine that the statement “applies to someone called Chris”. Study A and B take roughly an hour to complete including consent and debrief. Study C takes around 50 minutes to complete including consent and debrief.
What are the possible benefits and risks of participating?
Advantages of taking part in the study include adding to scientific knowledge about dementia and how information about diagnosis is communicated. Disadvantages of taking part include memory tasks that may be upsetting or cause some participants to feel tired.
Where is the study run from?
University of the West of England, Bristol (UK)
When is the study starting and how long is it expected to run for?
December 2014 to October 2016
Who is funding the study?
Alzheimer's Society (UK)
Who is the main contact?
Miss Emily Dodd
Trial website
Contact information
Type
Scientific
Primary contact
Miss Emily Dodd
ORCID ID
http://orcid.org/0000-0002-9505-257X
Contact details
Frenchay Campus
University of the West of England
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
Type
Scientific
Additional contact
Prof Richard Cheston
ORCID ID
http://orcid.org/0000-0002-7466-3777
Contact details
Frenchay Campus
University of the West of England
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17952
Study information
Scientific title
Mnemic neglect in people affected with mild Alzheimer's disease and dementia: replicating and extending findings from experimental social psychology
Acronym
Study hypothesis
There are three studies within this project, each with their own question:
Study A - do people with dementia show a preferential recall of neutral rather than illness-related words? Study B - do people with dementia show mnemic neglect?
Study C - is there a bias towards recall descriptions of dementia for the self, compared to descriptions of dementia relating to others?
Ethics approval
NRES Committee South West – Frenchay, 18/12/2014, ref: 14/SW/1142
Study design
Both; Interventional and Observational; Design type: Not specified, Case-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Dementias and neurodegeneration; Subtopic: Dementia; Disease: Dementia
Intervention
Participants have either been diagnosed with a form of dementia or are healthy volunteers (control group). Participants are asked to carry out a number of memory tests to examine:
Study A - recall of neutral versus illness related words
Study B - recall of negative and positive behavioural statements
Study C - recall of statements related to dementia
Study A is a simple memory test of words with no randomisation, everyone gets the same word list. Participants taking part in in studies B and C are randomly allocated to one of two groups. Those in group 1 are asked to imagine the statements as “applies to yourself". Those in group 2 are asked to imagine that the statement “applies to someone called Chris”. Study A and B take roughly an hour to complete including consent and debrief. Study C takes around 50 minutes to complete including consent and debrief.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current primary outcome measures as of 11/01/2017:
Study A: the mean number of dementia and non-dementia words recalled
Study B: the mean number of behaviour statements recalled (central or peripheral and positive or negative)
Study C: the mean number of high threat and low threat dementia statements recalled
There was only one timepoint to this study, the research appointment lasted up to an hour and the method was to simply count up the number of correct words/behaviours/statements recalled or recognised by each participant
Previous primary outcome measures:
Number of words, statements, descriptions recalled:
1. Straight after presentation
2. After a 2 minute delay
Secondary outcome measures
Current secondary outcome measures as of 11/01/2017:
All three studies: recognition scores and intrusion errors
There was only one timepoint to this study, the research appointment lasted up to an hour and method was to simply count up the number of correct words/behaviours/statements recalled or recognised by each participant
Previous secondary outcome measures:
Recognition of words, statements and descriptions after recall tasks:
1. Straight after presentation
2. After a 2 minute delay
Overall trial start date
01/12/2014
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A diagnosis made within the previous 18 months by a consultant psychiatrist of either probable Alzheimer’s disease according to the NINCDS-ADRDA criteria (McKhann et al, 1984) or probable vascular dementia according to the NINDS-IREN criteria (Román et al, 1993) or a mixed form of these
2. Mild levels of cognitive impairment (e.g. MOCA score over 12 or equivalent score on an alternative assessment tool)
3. The capacity to consent to be part of the research
4. Sufficient communication skills to be able to take part in the research
Control group:
Healthy volunteers recruited from Join Dementia Research (JDR) register, students and staff at the University of the West of England
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 110; UK Sample Size: 110; Description: 50 participants will be recruited in study A and B from RICE memory clinic; 60 participants will be recruited to study C from AWP and Devon Partnership memory clinics
Participant exclusion criteria
1. They have a significant history of pre-morbid psychiatric problems
2. They have a diagnosis of dementia with Lewy Bodies (McKeith, 2002) or frontal-temporal dementia (Snowden, Neary and Mann (2002)
3. If deficits in short-term memory are not a primary cause of disability
Recruitment start date
01/02/2015
Recruitment end date
31/07/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of the West of England, Bristol
Faculty of Health & Life Sciences
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
Funders
Funder type
Government
Funder name
Alzheimer's Society
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Findings will be published in peer-reviewed journals at the end of the study. A preliminary survey conducted on the general population was used to generate and validate the descriptions used in study C. The results of this will be published. Participants will receive a written lay summary of the findings.
IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/07/2017
Participant level data
To be made available at a later date
Basic results (scientific)
See additional file ISRCTN30485698_BasicResults_15Nov16.docx
Publication list
Publication citations
Additional files
- ISRCTN30485698_BasicResults_15Nov16.docx Uploaded 11/01/2017