Dementia Early Recognition and Response in Primary Care - Full Text View

Sponsors and Collaborators:	University College, London National Institutes of Health Research (NIHR) 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 Imperial College London
Information provided by:	University College, London
ClinicalTrials.gov Identifier:	NCT00866099

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 II Phase III

MedlinePlus related topics: Dementia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Evidence-Based Interventions In Dementia EVIDEM-ED: Early Recognition and Response in Primary Care

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:	May 2009

Arms	Assigned Interventions
"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.	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.

Arms

Assigned Interventions

"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.

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.

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

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

Contacts

Contact: Steve Iliffe, BSc, MB BS, FRCGP	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, Greater London
University College London
London, Greater London, United Kingdom, NW3 2PF

Sponsors and Collaborators

University College, London

National Institutes of Health Research (NIHR)

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

Imperial College London

Investigators

Principal Investigator:

Jane Wilcock, MA(hons), MSc

University College, London

More Information

Additional Information:

programme website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University College London ( Professor Steve Iliffe )
Study ID Numbers:	FIS No: 49287, Award Code: GZFP
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866099 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University College, London:

Dementia
primary care
early diagnosis
psychosocial interventions
cholinesterase inhibitors

Study placed in the following topic categories:

Cholinesterase Inhibitors
Neurotransmitter Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases

Cholinergic Agents
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Enzyme Inhibitors
Brain Diseases

Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia

ClinicalTrials.gov processed this record on May 07, 2009