Condition category
Mental and Behavioural Disorders
Date applied
21/07/2017
Date assigned
31/07/2017
Last edited
01/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

www.ucl.ac.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes