NCT00866099

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 19, 2010

Status Verified

March 1, 2009

Enrollment Period

1.8 years

First QC Date

March 19, 2009

Last Update Submit

April 16, 2010

Conditions

Keywords

Dementiaprimary careearly diagnosispsychosocial interventionscholinesterase inhibitors

Outcome Measures

Primary Outcomes (1)

  • An increase in the proportion of patients with dementia receiving two dementia reviews per year, from 20% to 50%

    twelve month follow up

Secondary Outcomes (7)

  • quality of life, met and unmet need in carers and/or people with dementia

    twelve month follow up

  • documented concordance with intervention recommendations on recording disclosure decisions & consequences

    twelve month follow up

  • documented concordance with screening for depression

    twelve month follow up

  • documented concordance with referral to social services

    twelve month follow up

  • documented concordance with informing people with dementia and their carers about relevant local voluntary organisations

    twelve month follow up

  • +2 more secondary outcomes

Study Arms (2)

"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

Interventions

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.

Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with memory or other cognitive impairments suggestive of dementia syndrome
  • those with a formal diagnosis of dementia, of any type.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Primary Care and Population Health

London, England, NW3 2PF, United Kingdom

RECRUITING

University College London

London, Greater London, NW3 2PF, United Kingdom

ENROLLING BY INVITATION

Related Publications (2)

  • 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.

  • Iliffe 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.

Related Links

MeSH Terms

Conditions

DementiaDisease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jane Wilcock, MA(hons) MSc

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Iliffe, BScMBBSFRCGP

CONTACT

Jane Wilcock, MA(hons) MSc

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2011

Study Completion

September 1, 2012

Last Updated

April 19, 2010

Record last verified: 2009-03

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