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Trial record 2 of 2464 for:    Dementia

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University College, London.
Recruitment status was  Recruiting
Sponsor:
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
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT00866099
First received: March 19, 2009
Last updated: April 16, 2010
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Dementia
Other: Educational Dementia training
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evidence-based Interventions In Dementia EVIDEM-ED: Early Recognition and Response in Primary Care

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life, met and unmet need in carers and/or people with dementia [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]
  • documented concordance with intervention recommendations on recording disclosure decisions & consequences [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]
  • documented concordance with screening for depression [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]
  • documented concordance with referral to social services [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]
  • documented concordance with informing people with dementia and their carers about relevant local voluntary organisations [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]
  • documented concordance with provision of legal information [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]
  • documented concordance with shared management of cholinesterase inhibitor medication [ Time Frame: twelve month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: July 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Name: Educational dementia training

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866099

Contacts
Contact: Steve Iliffe, BScMBBSFRCGP 0044-207-830-2393 s.iliffe@pcps.ucl.ac.uk
Contact: Jane Wilcock, MA(hons) MSc 0044-207-830-2239 ext 38370 j.wilcock@pcps.ucl.ac.uk

Locations
United Kingdom
Department of Primary Care and Population Health Recruiting
London, England, United Kingdom, NW3 2PF
Contact: Jane Wilcock, MA(hons) MSc    +44(0)20 7830 2239 ext 38370    j.wilcock@pcps.ucl.ac.uk   
Contact: Priya Jain, MSc    +44(0)20 7830 2239 ext 38370    p.jain@pcps.ucl.ac.uk   
Sub-Investigator: Jane Wilcock, MA (hons) MSc         
Principal Investigator: Steve Iliffe, BSc, MB BS, FRCGP         
University College London Enrolling by invitation
London, Greater London, United Kingdom, NW3 2PF
Sponsors and Collaborators
University College, London
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
Principal Investigator: Jane Wilcock, MA(hons) MSc University College, London
  More Information

Additional Information:
No publications provided by University College, London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Steve Iliffe, University College London
ClinicalTrials.gov Identifier: NCT00866099     History of Changes
Other Study ID Numbers: FIS No: 49287, Award Code: GZFP
Study First Received: March 19, 2009
Last Updated: April 16, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
Dementia
primary care
early diagnosis
psychosocial interventions
cholinesterase inhibitors

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014