A randomised single blind controlled trial evaluating an evidence-based psychological therapy package for dementia
| ISRCTN | ISRCTN25574370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25574370 |
| Secondary identifying numbers | RDC01638 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin Orrell
Scientific
Scientific
University College London Medical School
Wolfson Building
Riding House Street
London
W1N 8AA
United Kingdom
Study information
| Study design | Randomised single blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The study is a randomised single blind controlled trial evaluating an evidence-based psychological therapy package for people with dementia, both in day care and in residential care. In addition, the study will develop and evaluate a training package which will enable a variety of disciplines to organise and run similar groups. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous system diseases: Dementia |
| Intervention | 1. Psychological therapy 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | Mini Mental State Examination (MMSE) (Folstein et al., 1975) A brief, well established valid and reliable test of cognitive function. Widely used in the evaluation of drug trials and psychological therapies. The MMSE would enable the results of this study to be compared with the results of other researchers. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1999 |
| Completion date | 01/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 220 |
| Key inclusion criteria | 220 patients (65 or over) with dementia attending psychiatric day hospitals or dementia day centres, or in residential homes. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 01/03/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London Medical School
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
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 | 01/11/2007 | Yes | No |
