Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Orrell

ORCID ID

Contact details

University College London Medical School
Wolfson Building
Riding House Street
London
W1N 8AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC01638

Study information

Scientific title

Acronym

Study hypothesis

The study is a randomised single blind controlled trial evaluating an evidence-based psychological therapy package for people with dementia, both in day care and in residential care. In addition, the study will develop and evaluate a training package which will enable a variety of disciplines to organise and run similar groups.

Ethics approval

Not provided at time of registration

Study design

Randomised single blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous system diseases: Dementia

Intervention

1. Psychological therapy
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Mini Mental State Examination (MMSE) (Folstein et al., 1975) A brief, well established valid and reliable test of cognitive function. Widely used in the evaluation of drug trials and psychological therapies. The MMSE would enable the results of this study to be compared with the results of other researchers.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1999

Overall trial end date

01/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

220 patients (65 or over) with dementia attending psychiatric day hospitals or dementia day centres, or in residential homes.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

220

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1999

Recruitment end date

01/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Medical School
London
W1N 8AA
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17394129

Publication citations

  1. Results

    Orrell M, Hancock G, Hoe J, Woods B, Livingston G, Challis D, A cluster randomised controlled trial to reduce the unmet needs of people with dementia living in residential care., Int J Geriatr Psychiatry, 2007, 22, 11, 1127-1134, doi: 10.1002/gps.1801.

Additional files

Editorial Notes