Condition category
Mental and Behavioural Disorders
Date applied
28/05/2009
Date assigned
27/08/2009
Last edited
22/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.evidem.org.uk/projects/evidem-ed.htm

Contact information

Type

Scientific

Primary contact

Prof Steve Iliffe

ORCID ID

Contact details

Research Department of Primary Care & Population Health
University College London
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7830 2239
s.iliffe@pcps.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00866099

Protocol/serial number

Dendron 4932; 09/0133

Study information

Scientific title

Evidence-based interventions in dementia: a randomised controlled trial of an educational programme to improve early recognition and response in primary care

Acronym

EVIDEM-ED

Study hypothesis

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

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)

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

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 sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

01/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/06/2009

Recruitment end date

01/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Research Department of Primary Care & Population Health
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20146803
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24257429

Publication citations

  1. Protocol

    Iliffe S, Wilcock J, Griffin M, Jain P, Thuné-Boyle I, Koch T, Lefford F, Evidence-based interventions in dementia: A pragmatic cluster-randomised trial of an educational intervention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED)., Trials, 2010, 11, 13, doi: 10.1186/1745-6215-11-13.

  2. Results

    Wilcock J, Iliffe S, Griffin M, Jain P, Thuné-Boyle I, Lefford F, Rapp D, Tailored educational intervention for primary care to improve the management of dementia: the EVIDEM-ED cluster randomized controlled trial., Trials, 2013, 14, 397, doi: 10.1186/1745-6215-14-397.

Additional files

Editorial Notes