Plain English Summary
Background and study aims
People from minority ethnic backgrounds tend to seek help later for dementia so their outcomes are likely to be worse. An educational programme has been designed to encourage South Asian people to seek help for dementia earlier. This involves providing people aged over 50 who are South Asian with information regarding dementia through their GPs. This programme needs to be tested to see how feasible it is to recruit and follow up participants in order to determine if the intervention is acceptable. The aim of this study is to evaluate the acceptability and feasibility of a programme that provides South Asian people with information about dementia to encourage them to seek help earlier.
Who can participate?
South Asian adults aged 50 and older who have not been diagnosed with dementia.
What does the study involve?
Potential participants are sent a letter from their GP informing them about the research study and advising them to get in touch with the researchers should they wish to take part. Once participants have indicated their interest in the study, they are sent the participant information sheet which has more detail about the study. Once they have had time to read the information sheet (at least 24 hours), the researcher contacts them to ask if they agree to take part. Participants are allocated to one of two groups. Those in the first group receive a letter and video about dementia. Those in the second group do not receive anything. Participants then are asked to make an appointment where they are asked questions about themselves, what they know about dementia and how they feel about getting help for memory problems. This same questionnaire is then repeated at a three month follow up appointment.
What are the possible benefits and risks of participating?
There are no direct benefits with participating however participants receive high street vouchers to compensate for their time completing the questionnaires. There are no direct risks with participating however participants may find the questions about dementia distressing.
Where is the study run from?
This study is being run by University College London (UK) and takes place in eight health centres in the UK.
When is the study starting and how long is it expected to run for?
January 2013 to December 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Naaheed Mukadam
n.mukadam@ucl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Naaheed Mukadam
ORCID ID
http://orcid.org/0000-0001-8635-9521
Contact details
UCL Division of Psychiatry
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 207 6799251
n.mukadam@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12 LO 1584
Study information
Scientific title
Encouraging Access for South Asians to Timely Dementia Diagnosis: A pilot cluster randomised controlled trial
Acronym
EAST-Dem
Study hypothesis
It is feasible to recruit and follow up people for a pilot trial of an intervention to encourage help-seeking for dementia and the intervention will be acceptable.
Ethics approval
NRES Committee Fulham, 08/10/2012, ref: 12/LO/1584
Study design
Pilot cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Condition
Dementia
Intervention
Potential participants are sent a letter from their GP informing them about the research study and advising them to get in touch with the researchers should they wish to take part. Once participants have indicated their interest in the study, they are sent the participant information sheet which has more detail about the study. Once they have had time to read the information sheet (at least 24 hours), the researcher contacts them to ask if they agree to take part. Participants are then randomly allocated to one of two groups.
Intervention group: Participants are given a letter from their GP with an enclosed leaflet and DVD about dementia and getting help for memory symptoms. This is sent to participants once and they are then given complete an initial questionnaires and repeat the questionnaire again after three months.
Control group: Participants in this group receive no intervention and complete the same initial questionnaire and repeated questionnaire at three months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Acceptability of intervention is measured using a Likert scale rating the intervention from completely unacceptable (1) to completely acceptable (5)
2. Feasibility of recruitment is measured using the proportion of people who consented to take part after initially expressing an interest in the study and follow-up is measured using the proportion of people who completed follow-up out of the initial sample
Secondary outcome measures
1. Behavioural intention is measured using the APEND questionnaire, at the start of the study and approximately 3 months after the initial visit
2. Knowledge about dementia is measured using Dementia Knowledge Questionnaire at the start of the study and approximately 3 months after the initial visit
Overall trial start date
01/01/2013
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. South Asian person registered to participating GP practice
2. Aged over 50
3. No known diagnosis of dementia
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Diagnosis of dementia
2. Aged under 50
3. Not South Asian
4. No capacity to consent
Recruitment start date
20/01/2016
Recruitment end date
02/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
Division of Psychiatry
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
Trial participating centre
Hampstead Group practice
The Hampstead Group Practice
75 Fleet Road
London
NW3 2QU
United Kingdom
Trial participating centre
Prince of Wales Medical Centre
52 Prince of Wales Road
London
London NW5 3LN
United Kingdom
Trial participating centre
Mathukia's Surgery
281 Ilford Lane
Ilford
IG1 2SF
United Kingdom
Trial participating centre
West Hampstead Medical Centre
9 Solent Road
London
NW6 1TP
United Kingdom
Trial participating centre
Dr Chawla Surgery
60 Victoria Road
Barking
-
United Kingdom
Trial participating centre
King Edwards Medical Group
King Edward’s Medical Centre
1 King Edward’s Road
Barking
IG11 7TB
United Kingdom
Trial participating centre
Abbey Medical Centre
85 Abbey Road
London
NW8 0AG
United Kingdom
Trial participating centre
Belsize Priory Medical Practice
208 Belsize Road
London
NW6 4DX
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Joint Research Office (part of the Research Support Centre)
UCL
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Intent to publish our findings in a peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Naaheed Mukadam at n.mukadam@ucl.ac.uk.
Intention to publish date
12/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29108532