ISRCTN ISRCTN30485698
DOI https://doi.org/10.1186/ISRCTN30485698
Secondary identifying numbers 17952
Submission date
08/01/2015
Registration date
12/01/2015
Last edited
09/02/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Miss Emily Dodd
Scientific

Frenchay Campus
University of the West of England
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

ORCiD logoORCID ID 0000-0002-9505-257X
Prof Richard Cheston
Scientific

Frenchay Campus
University of the West of England
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

ORCiD logoORCID ID 0000-0002-7466-3777

Study information

Study designBoth; Interventional and Observational; Design type: Not specified, Case-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleMnemic neglect in people affected with mild Alzheimer's disease and dementia: replicating and extending findings from experimental social psychology
Study objectivesThere 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(s)NRES Committee South West – Frenchay, 18/12/2014, ref: 14/SW/1142
Health condition(s) or problem(s) studiedTopic: Dementias and neurodegeneration; Subtopic: Dementia; Disease: Dementia
InterventionParticipants 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 typeBehavioural
Primary outcome measureCurrent 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 measuresCurrent 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 study start date01/12/2014
Completion date01/10/2016

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned 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
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2015
Date of final enrolment31/07/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of the West of England, Bristol
Faculty of Health & Life Sciences
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom

Sponsor information

University of the West of England, Bristol
University/education

Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
England
United Kingdom

ROR logo "ROR" https://ror.org/02nwg5t34

Funders

Funder type

Government

Alzheimer's Society
Private sector organisation / Associations and societies (private and public)
Alternative name(s)
alzheimerssoc
Location
United Kingdom

Results and Publications

Intention to publish date01/07/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planFindings 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 planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 15/11/2016 11/01/2017 No No
Results article results 01/08/2018 Yes No
Results article 26/03/2019 09/02/2023 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN30485698_BasicResults_15Nov16.docx
Uploaded 11/01/2017

Editorial Notes

09/02/2023: Publication reference added.
30/08/2018: Publication reference added.
11/01/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/11/2015 to 01/10/2016.
2. A basic results summary was added.