Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16543297
Publication citations
-
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.