Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.
-
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.