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
| ISRCTN | ISRCTN33534489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33534489 |
| Protocol serial number | N0577167824 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Funder | North East London Mental Health NHS Trust (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 15/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Afifa Qazi
Scientific
Scientific
Old Age Psychiatry
Mascalls Park Hospital
Mascalls Lane
Brentwood
CM15 5HQ
United Kingdom
| Phone | +44 01277 302736 |
|---|---|
| afifaqazi@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific 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 |
| Study objectives | 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? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Alzheimer's disease |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Rating of Anxiety in Dementia (RAID), QoL-AD and the General Health Questionnaire (GHQ-12) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Key inclusion criteria | Participants will be selected from 5 centres within North East London Mental Health Trust. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Old Age Psychiatry
Brentwood
CM15 5HQ
United Kingdom
CM15 5HQ
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 |
Editorial Notes
15/03/2017: No publications found in PubMed, verifying study status with principal investigator
