Can the behavioural symptoms of people severely affected by dementia be effectively and safely managed without use of regular psychotropic medication?

ISRCTN	ISRCTN92829053
DOI	https://doi.org/10.1186/ISRCTN92829053
Protocol serial number	QRD/2002/01/01
Sponsor	Alzheimer's Society (UK)
Funder	Alzheimer's Society, The Community Fund (RG 24052)

Submission date: 02/08/2002
Registration date: 02/08/2002
Last edited: 08/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert Howard
Scientific

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

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FITS
Study objectives	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(s)	No ethics information required at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	340
Key inclusion criteria	Being a continuing care facility providing care for people with severe dementia
Key exclusion criteria	Not applicable
Date of first enrolment	01/06/2003
Date of final enrolment	01/02/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Psychological Medicine

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2006		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes