The FITS Trial – a cluster randomised trial to test whether enhanced care reduces the need for psychotropic medication in people with severe dementia
Nicola Alder, Ed Juszczak and Rosamund Weatherall in three regions headed by Robin Jacoby and Jane Fossey (Oxford), Robert Howard (London) and Clive Ballard (Newcastle)
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. We are carrying out a cluster randomised controlled trial of a Focused Intervention Training and Support (FITS) package within Continuing Care facilities in order to: (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, and (4) to examine whether a positive intervention on residents has a beneficial effect on staff. Baseline data collection started in June 2003; the intervention began in August 2003 and ran for 12 months; follow-up data collection began in August 2004 and will be completed by February 2005.
The FITS project has already resulted in a number of sub-studies, publications, presentations and benefits. A summary of these is available on request.
