A randomised single blind controlled trial evaluating an evidence-based psychological therapy package for dementia
| ISRCTN | ISRCTN25574370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25574370 |
| Protocol serial number | RDC01638 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single blind controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University College London Medical School
London
W1N 8AA
United Kingdom
W1N 8AA
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 | 01/11/2007 | Yes | No |
