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

April 16, 2010 updated by: University College, London

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, NW3 2PF
        • Recruiting
        • Department of Primary Care and Population Health
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jane Wilcock, MA (hons) MSc
        • Principal Investigator:
          • Steve Iliffe, BSc, MB BS, FRCGP
    • Greater London
      • London, Greater London, United Kingdom, NW3 2PF
        • Enrolling by invitation
        • University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: "Normal Care"
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.
Experimental: Training
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.
Other: Educational Dementia training

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
twelve month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life, met and unmet need in carers and/or people with dementia
Time Frame: twelve month follow up
twelve month follow up
documented concordance with intervention recommendations on recording disclosure decisions & consequences
Time Frame: twelve month follow up
twelve month follow up
documented concordance with screening for depression
Time Frame: twelve month follow up
twelve month follow up
documented concordance with referral to social services
Time Frame: twelve month follow up
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
twelve month follow up
documented concordance with provision of legal information
Time Frame: twelve month follow up
twelve month follow up
documented concordance with shared management of cholinesterase inhibitor medication
Time Frame: twelve month follow up
twelve month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

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

Investigators

  • Principal Investigator: Jane Wilcock, MA(hons) MSc, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2010

Last Update Submitted That Met QC Criteria

April 16, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS No: 49287
  • Award Code: GZFP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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