Dementia early recognition and response project

ISRCTN	ISRCTN20646614
DOI	https://doi.org/10.1186/ISRCTN20646614
ClinicalTrials.gov number	NCT00866099
Secondary identifying numbers	Dendron 4932; 09/0133

Submission date: 28/05/2009
Registration date: 27/08/2009
Last edited: 22/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Steve Iliffe
Scientific

Research Department of Primary Care & Population Health
University College London
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Phone	+44 (0)20 7830 2239
Email	s.iliffe@pcps.ucl.ac.uk

Study information

Study design	Unblinded cluster randomised controlled trial with a pre-post design, with two arms
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evidence-based interventions in dementia: a randomised controlled trial of an educational programme to improve early recognition and response in primary care
Study acronym	EVIDEM-ED
Study objectives	Primary care practice teams who receive a tailored educational package will show improved recognition and response to dementia than control practices who undertake normal care.
Ethics approval(s)	Southampton and South West Hampshire Research Ethics Committee A approval pending as of 03/06/2009. Decision expected 09/06/2009 (ref: 09/H0502/77)
Health condition(s) or problem(s) studied	Dementia
Intervention	The educational intervention consists of practice based workshops with a tailored curriculum designed by a multidisciplinary expert group, supplemented by computer based reference support software. An experienced general practitioner with a background in postgraduate education will facilitate the small group workshops with the practice team. The computer software will include information for the investigation and management of dementia and will assist clinical reasoning and care planning. Control practices will be provided with a summary of the National Institute for Health and Clinical Excellence (NICE) and the Social Care Institute for Excellence (SCIE) dementia guidelines (2006).
Intervention type	Other
Primary outcome measure	An increase of 50% between groups of patients with dementia receiving two dementia reviews per year, i.e. 20% (control) versus 70% (intervention) at follow-up after training. Primary and secondary outcome measures will be taken at baseline and again 12 months later.
Secondary outcome measures	1. Documented concordance with intervention recommendations on recording disclosure decisions and consequences 2. Screening for depression 3. Referral to social services 4. Informing people with dementia about relevant local voluntary organisations 5. Provision of legal information and shared management of cholinesterase inhibitor medication 6. Benefits to people with dementia and their families, measured using standardised instruments like Dementia Quality of Life (DEMQOL) and the Carer Strain Index 7. Brief interviews with carers Primary and secondary outcome measures will be taken at baseline and again 12 months later.
Overall study start date	01/06/2009
Completion date	01/10/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	200
Key inclusion criteria	1. Memory or other cognitive impairments suggestive of dementia syndrome 2. A formal diagnosis of dementia, of any type 3. Male or female participants, no age limits
Key exclusion criteria	1. Patients and carers who are already involved in concurrent research 2. If the key professional feels that an approach to the person with dementia or their carer would be inappropriate, for example the dementia is very severe, or that an approach may increase distress 3. Any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted
Date of first enrolment	01/06/2009
Date of final enrolment	01/10/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Research Department of Primary Care & Population Health

London
NW3 2PF
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Joint UCLH/UCL Biomedical Research Unit
1st Floor Maple House
149 Tottenham Court Road
London
W1P 9LL
England
United Kingdom

Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1005)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	10/02/2010		Yes	No
Results article	results	20/11/2013		Yes	No
HRA research summary			28/06/2023	No	No