Plain English Summary
Background and study aims
In the UK, about 820,000 people have dementia (brain disorder). Nearly two-thirds of people never find out and for many that do, diagnosis takes a long time with the patient and family overcoming numerous obstacles. Although it is UK national policy in the Dementia Strategy that people are diagnosed early, and this has been accompanied by a nationwide information campaign, there has been little progress. Diagnostic barriers include people with memory problems being reluctant to see their general practitioner (GP), GPs not seeing there is a problem or referring for help, and patient and family concerns about stigma. We have designed a leaflet based on the CHOICE project which asked family carers what the problems were in making decisions for people with dementia and how they overcame them. The most common problem that carers struggled with was getting a diagnosis and help. The CHOICE leaflet for our study was developed from family carers of people with dementias answers. The aim of this study is to increase timely diagnosis of dementia. We intend to send a personal letter from the GP with the CHOICE leaflet explaining what to do to overcome barriers to getting help for memory problems to all people aged over 70 in the practice. We will find out whether this enables people with dementia to receive an earlier diagnosis.
Who can participate?
We are recruiting GP practices to the study. Our study will include all patients in the GP practices over the age of 70 years (unless already known to have dementia or living in a care home).
What does the study involve?
The GP practices will be randomly allocated to one of two groups. One group (intervention GP practices) will send the leaflet along with a letter from the GP to the patients and the other group provides usual care (control practices). The GP letter will go to every participant in the intervention group with an explanation about how memory problems which interfere with life become more common as people age. It will ask for people to consider the leaflet for themselves or members of their family. This will be sent to people who live alone as well as those living with others. We will test if this increases the number of people with undiagnosed dementia presenting with memory-related problems to their GP, the number of patients GPs refer appropriately to memory services, and if this referral is at an earlier stage. We will compare the brain function scores of those patients referred from the intervention GP practices to those from the control practices. If our method is successful we want to know whether the cost is low. We will calculate the cost for every extra person diagnosed and whether there are many people who are referred to memory services with no dementia (which would increase the cost).
What are the possible benefits and risks of participating?
Our leaflet addresses how to overcome the common problems diagnosing people with dementia. Early diagnosis is useful because although there is no cure, many people with dementia and family carers feel relieved by knowing what the diagnosis is. The diagnosis leads to treatment and more support which reduces crises, can improve quality of life and delay care home admission. It also allows people to make choices about current and future care and other plans. It is also thought to save money for the state and for individual family carers.
Where is the study run from?
The study is run from University College London and the research will take place in UCL Partners partnership trusts where our team work clinically. This will include local GP surgeries and hospitals including mental health trusts within North London and surrounding counties.
When is study starting and how long is it expected to run for?
The study will start in mid-2013 and will run for 12 months. The GP practices will be enrolled in the study for a period of 12 months.
Who is funding the study?
The Alzheimers Society (UK)
Who is the main contact?
Prof. Gill Livingston
g.livingston@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gill Livingston
ORCID ID
http://orcid.org/0000-0001-6741-5516
Contact details
Division of Psychiatry
University College London
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
-
g.livingston@ucl.ac.uk
Type
Scientific
Additional contact
Dr Juanita Hoe
ORCID ID
http://orcid.org/0000-0003-4647-8950
Contact details
Division of Psychiatry
University College London
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
-
j.hoe@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
177 (PG-2012-183)
Study information
Scientific title
Facilitating Early Diagnosis of Dementia (FED-D): a pragmatic, multi-site, cluster randomised controlled trial
Acronym
FED-D
Study hypothesis
Does sending a leaflet on how to overcome barriers to accessing help for dementia to people aged over 70 registered in a general practice, with an accompanying personal letter from the GP, lead to people with dementia presenting earlier to specialist dementia services compared with usual care over 12 months and if so, is it at low cost? We will test the hypotheses that, over 12 months people receiving the intervention will present earlier (mean of 3 points higher on MMSE score) than those not receiving it and that the costs of the intervention are small.
Ethics approval
NRES Committee London - Queen Square, 20/08/2013, ref: 13/LO/0996
Study design
Pragmatic multi-site cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheetDr Juanita HoeFED-D Research Project CoordinatorUCL Mental Health Sciences UnitUniversity College LondonCharles Bell House 67 73 Riding House Street London W1W 7EJ Email: j.hoe@ucl.ac.uk
Condition
Dementia
Intervention
We intend to send a personal letter from the GP with the CHOICE leaflet explaining what to do to overcome barriers to getting help for memory problem to all people aged over 70 in the practice
Control: usual care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The primary outcome is the cognitive score as measured by the Mini Mental State Examination (MMSE) of people referred to memory services in the intervention and control groups who receive a diagnosis of dementia. The minimum clinically important difference in MMSE score is three points and is the most widely used standard test of cognitive function. We will collate the baseline MMSE score from the new patients presenting to memory clinic (i.e. MMSE scores of new presentations) at 3, 6 and 12 months after sending the letters. We are not collecting follow-up MMSEs. There is a maximum score of 30, with scores of 0-10=severe, 11-20=moderate, and 21-24=mild dementia.
Added 05/01/2016:
As many memory services were using other cognitive measures than the MMSE, most commonly the 100 point Addenbrookes Cognitive Examination (ACE-R and ACE-III), it was agreed before we began the analysis to include patients without MMSE scores but with ACE scores. We used data on the latter to estimate the missing MMSE scores. We therefore converted the ACE scores so that ACE and MMSE were used as a single outcome score. The change to the primary outcome was agreed on 08/12/2014.
Secondary outcome measures
1. Number of people presenting with a possible diagnosis of dementia will be collected from GPs practices using MiQUEST (a Department of Health computer system allowing anonymised data extraction from GP practices). We will collect the number of people presenting to their GP who are and who are not referred on to memory services.
2. Numbers of patients referred to memory services from participating intervention and control practices
3. The number of memory services appointments offered and people attending for diagnostic assessment
4. The number of people referred who do not have dementia or mild cognitive impairment
5. Costs of implementing the intervention, including the costs associated with the CHOICE leaflet (printing, and distribution), GP visits to discuss possible diagnoses of dementia and use of memory services and the cost of assessing those with and without dementia
6. We will systematically ask clinicians about any inappropriate presentations and patient distress and record these as adverse events
Overall trial start date
01/07/2013
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
We are recruiting GP practices to the study and our study will include all patients in the GP practices over the age of 70 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
We aim to recruit 22 GP practices, so there will be 11 GP practices in both the treatment and control groups. The required sample size of patients aged over 70 in each arm is 93
Participant exclusion criteria
The intervention will not be given to registered patients within included GP practices over the age of 70 years who have a diagnosis of dementia, live in a care home or have been referred to specialist memory services
Recruitment start date
27/09/2013
Recruitment end date
11/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UCL Mental Health Sciences Unit
London
W1W 7EJ
United Kingdom
Trial participating centre
Camden Memory Service
The Peckwater Centre
6 Peckwater Street
London
NW5 2TX
United Kingdom
Trial participating centre
Waltham Forest Memory Service
Red Oak Lodge
17 Thorne Close
Langthorne Road
Leytonstone
London
E11 4HU
United Kingdom
Trial participating centre
Havering Memory Service
119—121 Suttons House
Hornchurch
RM12 6RU
United Kingdom
Trial participating centre
Redbridge Memory Service
Grovelands
Grove Road
Chadwell Heath
RM6 4XH
United Kingdom
Trial participating centre
Barking & Dagenham Memory Service
Broad Street Health Centre
Morland Road
Dagenham
RM10 9HU
United Kingdom
Trial participating centre
Tower Hamlets Diagnostic Memory Clinic
The Robinson Centre
Mile End Hospital
275 Bancroft Road
Mile End
London
E1 4DG
United Kingdom
Trial participating centre
City & Hackney Diagnostic Memory Clinic
Unit 1
30 Felstead Street
Homerton
London
E9 5LG
United Kingdom
Trial participating centre
Newham Diagnostic Memory Clinic
Newham First Avenue Resource Centre
103 First Avenue
Plaistow
London
E13 8AP
United Kingdom
Trial participating centre
Barnet Older Peoples CMHT
Level 3, Springwell Centre
Barnet Hospital
Wellhouse Lane
Barnet
EN5 3DJ
United Kingdom
Trial participating centre
Haringey Memory Service
Victoria Unit
St Ann’s Hospital
London
N15 3TH
United Kingdom
Trial participating centre
EMDASS East
North Place Annex
82 Great North Road
Hatfield
AL9 5BL
United Kingdom
Trial participating centre
EMDASS North West
Logandene
Ashley Close
Bennets End
Hemel Hempstead
HP3 8BL
United Kingdom
Trial participating centre
EMDASS North
Glaxo Day Hospital
Lister Hospital
Stevenage
SG1 4AB
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)203 447 9995
emma.osborn@uclh.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Alzheimer's Society Project Grant: 177 (PG-2012-183) (UK)
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
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28291781