| Source of record | UK Trials |
| ISRCTN | ISRCTN33534489 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0577167824 |
| Public title | The management of anxiety in Alzheimer's disease - A pilot study of a single-blind randomised controlled trial using an intervention package with a three month follow-up |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nervous System Diseases: Alzeihmer's disease |
| Study hypothesis | Does the management of anxiety in Alzheimer's disease result in a significant reduction in anxiety, improved QoL and an improvement in carer mental health? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Participants will be selected from 5 centres within North East London Mental Health Trust. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/11/2005 |
| Anticipated end date | 01/08/2006 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Systematic review of evidence.
2. Recruiting participants through day centres, lunch clubs with specialist provision for dementia.
3. Randomisation of participants.
4. Intervention package, which will involve a stepped care plan using physical, drug, social and psychological interventions.
5. Follow-up, which will be done 3 months post intervention.
6. Data-Analysis will be done on an intent to treat basis and will be achieved by using analysis of co-variance. |
| Primary outcome measure(s) | Rating of Anxiety in Dementia (RAID), QoL-AD and the General Health Questionnaire (GHQ-12) |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | North East London Mental Health NHS Trust (UK)
|
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Afifa Qazi |
| Contact details | Old Age Psychiatry
Mascalls Park Hospital
Mascalls Lane
Brentwood
United Kingdom
CM15 5HQ |
| Contact telephone | +44 01277 302736 |
| Contact fax | +44 |
| Contact email | afifaqazi@hotmail.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33534489 |
| Date last extracted from ISRCTN register | 17/04/2008 |
