Condition category
Mental and Behavioural Disorders
Date applied
02/08/2002
Date assigned
02/08/2002
Last edited
08/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.csm-oxford.org.uk/index.asp?o=1127

Contact information

Type

Scientific

Primary contact

Dr Robert Howard

ORCID ID

Contact details

Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

QRD/2002/01/01

Study information

Scientific title

Acronym

FITS

Study hypothesis

Many people with dementia are prescribed antidepressants and minor or major tranquillizers. This may be appropriate treatment for psychiatric symptoms such as depression, hallucinations or delusions, but use of these drugs to control behavioural symptoms that may arise out of agitation for example is controversial. Major tranquillizers are highly effective in the treatment of hallucinations and delusions, but the little evidence that we have suggests that they have only modest efficacy in improving behavioural symptoms. In contrast to the lack of evidence that these drugs are helpful in the treatment of people with dementia, there are clear costs associated with their use. All of these drugs have side-effects to which people with dementia are particularly sensitive. Further, some researchers believe that use of these drugs may be associated with an accelerated decline in dementia.

The aim of this trial is to test the effectiveness and acceptability of alternatives to regular psychotropic prescription within those people with dementia who present the most serious behavioural problems and who would thus be most likely to receive drug treatment.

Ethics approval

No ethics information required at time of registration.

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Dementia

Intervention

Focused Intervention Training and Support (FITS) package delivered to Care staff within Continuing Care facilities versus a simple staff support group

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Determine whether this approach reduces the need for neuroleptics and other sedative medications
2. To measure the safety of this intervention
3. Determine whether this improves the quality of life of those people with dementia resident in such facilities
4. To examine whether a positive intervention on residents has a beneficial effect on staff

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2003

Overall trial end date

01/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Being a continuing care facility providing care for people with severe dementia

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

340 (170 per arm)

Participant exclusion criteria

Not applicable

Recruitment start date

01/06/2003

Recruitment end date

01/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Psychological Medicine
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Alzheimer's Society (UK)

Sponsor details

Gordon House
10 Greencoat Place
London
SW1P 1PH
United Kingdom
+44 (0)207 306 0606
enquiries@alzheimers.org.uk

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Alzheimer's Society, The Community Fund (RG 24052)

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16543297

Publication citations

  1. Results

    Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, Howard R, Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial., BMJ, 2006, 332, 7544, 756-761, doi: 10.1136/bmj.38782.575868.7C.

Additional files

Editorial Notes