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 |
| Secondary identifying numbers | QRD/2002/01/01 |
- 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
Scientific
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 01/06/2003 |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 340 (170 per arm) |
| 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
- England
- United Kingdom
Study participating centre
Division of Psychological Medicine
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
Alzheimer's Society (UK)
Charity
Charity
Gordon House
10 Greencoat Place
London
SW1P 1PH
United Kingdom
| Phone | +44 (0)207 306 0606 |
|---|---|
| enquiries@alzheimers.org.uk | |
"ROR" |
https://ror.org/0472gwq90 |
Funders
Funder type
Charity
Alzheimer's Society, The Community Fund (RG 24052)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
