| Source of record | UK Trials |
| ISRCTN | ISRCTN92829053 |
| Date ISRCTN assigned | 02/08/2002 |
| Local reference number(s) | QRD/2002/01/01 |
| Public title | Can the behavioural symptoms of people severely affected by dementia be effectively and safely managed without use of regular psychotropic medication? |
| Scientific title |
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| Acronym | FITS |
| Disease/condition/study domain | Dementia |
| 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. |
| Design/methodology | Cluster randomised controlled trial |
| Research ethics review | No ethics information required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Being a continuing care facility providing care for people with severe dementia |
| Participants - exclusion criteria | Not applicable |
| Patient information material |
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| Anticipated start date | 01/06/2003 |
| Anticipated end date | 01/02/2005 |
| Status of trial | Completed |
| Target number of participants | 340 (170 per arm) |
| Interventions | Focused Intervention Training and Support (FITS) package delivered to Care staff within Continuing Care facilities versus a simple staff support group |
| 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 |
| Secondary outcome measure(s) | Not applicable |
| Trial website | http://www.csm-oxford.org.uk/index.asp?o=1127 |
| Sources of funding | Alzheimer's Society, The Community Fund (RG 24052) |
| Sponsor name | Alzheimer's Society (UK) |
| Sponsor details | Gordon House
10 Greencoat Place
London
United Kingdom
SW1P 1PH |
| Sponsor telephone | +44 (0)20 7306 0606 |
| Sponsor fax | +44 (0)20 7306 0808 |
| Sponsor email | enquiries@alzheimers.org.uk |
| Contact name | Dr Robert Howard |
| Contact details | Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
United Kingdom
SE5 8AF |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN92829053 |
| Date last extracted from ISRCTN register | 17/04/2008 |
