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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00866099
Other study ID # FIS No: 49287
Secondary ID Award Code: GZFP
Status Recruiting
Phase Phase 2/Phase 3
First received March 19, 2009
Last updated April 16, 2010
Start date July 2009
Est. completion date September 2012

Study information

Verified date March 2009
Source University College, London
Contact Steve Iliffe, BScMBBSFRCGP
Phone 0044-207-830-2393
Email s.iliffe@pcps.ucl.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date September 2012
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Department of Primary Care and Population Health London England
United Kingdom University College London London Greater London

Sponsors (8)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary An increase in the proportion of patients with dementia receiving two dementia reviews per year, from 20% to 50% twelve month follow up No
Secondary quality of life, met and unmet need in carers and/or people with dementia twelve month follow up No
Secondary documented concordance with intervention recommendations on recording disclosure decisions & consequences twelve month follow up No
Secondary documented concordance with screening for depression twelve month follow up No
Secondary documented concordance with referral to social services twelve month follow up No
Secondary documented concordance with informing people with dementia and their carers about relevant local voluntary organisations twelve month follow up No
Secondary documented concordance with provision of legal information twelve month follow up No
Secondary documented concordance with shared management of cholinesterase inhibitor medication twelve month follow up No
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