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Dementia Early Recognition and Response in Primary Care (EVIDEM-ED)

Primary Purpose

Dementia

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Educational Dementia training
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring Dementia, primary care, early diagnosis, psychosocial interventions, cholinesterase inhibitors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with memory or other cognitive impairments suggestive of dementia syndrome
  • those with a formal diagnosis of dementia, of any type.

Exclusion Criteria:

  • Patients and carers who are already involved in concurrent research
  • 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
  • and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted.

Sites / Locations

  • Department of Primary Care and Population HealthRecruiting
  • University College London

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

"Normal Care"

Training

Arm Description

Primary care practices randomly allocated will be given a summary of the NICE/SCIE dementia guidelines (2006) and offered workshop training and software at the end of the study.

Practices randomly allocated to the intervention arm will be asked to participate in tailored learning activities on dementia, over a three-month period and will be given an electronic training manual (based on Microsoft packages) which they can run in the background during and after consultations with people with known or suspected dementia syndrome and face-to- face individualised workshop sessions.

Outcomes

Primary Outcome Measures

An increase in the proportion of patients with dementia receiving two dementia reviews per year, from 20% to 50%

Secondary Outcome Measures

quality of life, met and unmet need in carers and/or people with dementia
documented concordance with intervention recommendations on recording disclosure decisions & consequences
documented concordance with screening for depression
documented concordance with referral to social services
documented concordance with informing people with dementia and their carers about relevant local voluntary organisations
documented concordance with provision of legal information
documented concordance with shared management of cholinesterase inhibitor medication

Full Information

First Posted
March 19, 2009
Last Updated
April 16, 2010
Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom, Central and North West London NHS Foundation Trust, King's College London, University of Hertfordshire, St George's, University of London, London School of Economics and Political Science, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00866099
Brief Title
Dementia Early Recognition and Response in Primary Care
Acronym
EVIDEM-ED
Official Title
Evidence-based Interventions In Dementia EVIDEM-ED: Early Recognition and Response in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom, Central and North West London NHS Foundation Trust, King's College London, University of Hertfordshire, St George's, University of London, London School of Economics and Political Science, Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to develop and test an educational intervention for dementia in primary care, combining timely diagnosis, psychosocial support around the period of diagnosis and management concordant with guidelines.
Detailed Description
Dementia presents many challenges for primary care. Early diagnosis is important as this allows those with dementia and their family care networks to engage with support services and plan for the future. These actions can relieve the significant psychological distress that people with dementia and close supporters may experience , and provide knowledge about the availability of medical and psycho-social support that can improved functioning and morale The main efforts to improve the identification and diagnosis of dementia should logically be targeted at primary care as this is the first point of contact for most individuals and their carers when faced with experiences of 'ill health'. There is, however, evidence that dementia remains under-detected and sub-optimally managed in general practice . An educational intervention that could enhance clinical practice, improving the skills of practitioners in the recognition of and response to dementia syndromes, could therefore be beneficial to people with dementia and their families, and potentially to health and social services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, primary care, early diagnosis, psychosocial interventions, cholinesterase inhibitors

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Normal Care"
Arm Type
No Intervention
Arm Description
Primary care practices randomly allocated will be given a summary of the NICE/SCIE dementia guidelines (2006) and offered workshop training and software at the end of the study.
Arm Title
Training
Arm Type
Experimental
Arm Description
Practices randomly allocated to the intervention arm will be asked to participate in tailored learning activities on dementia, over a three-month period and will be given an electronic training manual (based on Microsoft packages) which they can run in the background during and after consultations with people with known or suspected dementia syndrome and face-to- face individualised workshop sessions.
Intervention Type
Other
Intervention Name(s)
Educational Dementia training
Intervention Description
Tailored learning activities on dementia, over a three-month period and will be given an electronic training manual (based on Microsoft packages) which they can run in the background during and after consultations with people with known or suspected dementia syndrome and face-to- face individualised workshop sessions. Tailoring of the education programme is carried out in a three step process: 1) an educational needs analysis is carried our using a standard checklist to identify aspects of dementia care which the practice perceives as problematic for them; 2) a prescription for education is then written to address shortcomings; 3) the best forms of learning are then identified.
Primary Outcome Measure Information:
Title
An increase in the proportion of patients with dementia receiving two dementia reviews per year, from 20% to 50%
Time Frame
twelve month follow up
Secondary Outcome Measure Information:
Title
quality of life, met and unmet need in carers and/or people with dementia
Time Frame
twelve month follow up
Title
documented concordance with intervention recommendations on recording disclosure decisions & consequences
Time Frame
twelve month follow up
Title
documented concordance with screening for depression
Time Frame
twelve month follow up
Title
documented concordance with referral to social services
Time Frame
twelve month follow up
Title
documented concordance with informing people with dementia and their carers about relevant local voluntary organisations
Time Frame
twelve month follow up
Title
documented concordance with provision of legal information
Time Frame
twelve month follow up
Title
documented concordance with shared management of cholinesterase inhibitor medication
Time Frame
twelve month follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with memory or other cognitive impairments suggestive of dementia syndrome those with a formal diagnosis of dementia, of any type. Exclusion Criteria: Patients and carers who are already involved in concurrent research 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 and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Iliffe, BScMBBSFRCGP
Phone
0044-207-830-2393
Email
s.iliffe@pcps.ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Wilcock, MA(hons) MSc
Phone
0044-207-830-2239
Ext
38370
Email
j.wilcock@pcps.ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Wilcock, MA(hons) MSc
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Primary Care and Population Health
City
London
State/Province
England
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Wilcock, MA(hons) MSc
Phone
+44(0)20 7830 2239
Ext
38370
Email
j.wilcock@pcps.ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Priya Jain, MSc
Phone
+44(0)20 7830 2239
Ext
38370
Email
p.jain@pcps.ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Jane Wilcock, MA (hons) MSc
First Name & Middle Initial & Last Name & Degree
Steve Iliffe, BSc, MB BS, FRCGP
Facility Name
University College London
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Citations:
PubMed Identifier
24257429
Citation
Wilcock J, Iliffe S, Griffin M, Jain P, Thune-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 Nov 20;14:397. doi: 10.1186/1745-6215-14-397.
Results Reference
derived
PubMed Identifier
20146803
Citation
Iliffe S, Wilcock J, Griffin M, Jain P, Thune-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 Feb 10;11:13. doi: 10.1186/1745-6215-11-13.
Results Reference
derived
Links:
URL
http://www.evidem.org.uk
Description
programme website

Learn more about this trial

Dementia Early Recognition and Response in Primary Care

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