DementiaPhase 2/3EVIDEM-EDNCT00866099
Dementia Early Recognition and Response in Primary Care
A Phase 2/3 study testing Educational Dementia training in people with Dementia, run by University College, London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Educational Dementia training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2009to Sep 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with memory or other cognitive impairments suggestive of dementia syndrome
- those with a formal diagnosis of dementia, of any type.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Department of Primary Care and Population Health
London, England, NW3 2PF
Jane Wilcock, MA(hons) MSc, +44(0)20 7830 2239 ext. 38370, j.wilcock@pcps.ucl.ac.uk
Priya Jain, MSc, +44(0)20 7830 2239 ext. 38370, p.jain@pcps.ucl.ac.uk
- Enrolling by invitation
University College London
London, Greater London, NW3 2PF
About this study
Official title: Evidence-based Interventions In Dementia EVIDEM-ED: Early Recognition and Response in Primary Care
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Educational Dementia training
- Keywords
- Dementia, primary care, early diagnosis, psychosocial interventions, cholinesterase inhibitors
- Medical subject headings
- Dementia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Dementia trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "Normal Care" | No intervention | 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. |
| Training | Experimental | 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. Receives: Other: Educational Dementia training |
What is being measured
The primary outcome is the main question the study is designed to answer.
An increase in the proportion of patients with dementia receiving two dementia reviews per year, from 20% to 50%
Measured: twelve month follow up
Secondary outcomes (7)
quality of life, met and unmet need in carers and/or people with dementia
Measured: twelve month follow up
documented concordance with intervention recommendations on recording disclosure decisions & consequences
Measured: twelve month follow up
documented concordance with screening for depression
Measured: twelve month follow up
documented concordance with referral to social services
Measured: twelve month follow up
documented concordance with informing people with dementia and their carers about relevant local voluntary organisations
Measured: twelve month follow up
documented concordance with provision of legal information
Measured: twelve month follow up
documented concordance with shared management of cholinesterase inhibitor medication
Measured: twelve month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Jane Wilcock, MA(hons) MSc, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866099
- Sponsor's protocol ID
- FIS No: 49287
- Other IDs
- Award Code: GZFP
- Acronym
- EVIDEM-ED
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 19 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24257429Iliffe 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.
PubMed 20146803
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Interventions In Dementia EVIDEM-ED: Early Recognition and Response in Primary Care
- ClinicalTrials.gov ID
- NCT00866099
- Acronym / sponsor ID
- EVIDEM-ED / FIS No: 49287
- Conditions
- Dementia
- Keywords
- Dementia, primary care, early diagnosis, psychosocial interventions, cholinesterase inhibitors
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- 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
- Study start
- Jul 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Normal Care" | No intervention | –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. |
| Training | Experimental | Other: Educational Dementia trainingPractices 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with memory or other cognitive impairments suggestive of dementia syndrome
- those with a formal diagnosis of dementia, of any type.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Dementia trainingTailored 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. | Other | Training |
Primary outcome
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
7 secondary outcomes
quality of life, met and unmet need in carers and/or people with dementia
Time frame: twelve month follow up
documented concordance with intervention recommendations on recording disclosure decisions & consequences
Time frame: twelve month follow up
documented concordance with screening for depression
Time frame: twelve month follow up
documented concordance with referral to social services
Time frame: twelve month follow up
documented concordance with informing people with dementia and their carers about relevant local voluntary organisations
Time frame: twelve month follow up
documented concordance with provision of legal information
Time frame: twelve month follow up
documented concordance with shared management of cholinesterase inhibitor medication
Time frame: twelve month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2010.
- Derived from this study: PubMed 24257429Wilcock 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.
- Derived from this study: PubMed 20146803Iliffe 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.
- programme websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Wilcock, MA(hons) MSc principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Educational Dementia training in people with Dementia, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Iliffe, BScMBBSFRCGP (0044-207-830-2393, s.iliffe@pcps.ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00866099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2010.