Condition category
Nervous System Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Afifa Qazi

ORCID ID

Contact details

Old Age Psychiatry
Mascalls Park Hospital
Mascalls Lane
Brentwood
CM15 5HQ
United Kingdom
+44 01277 302736
afifaqazi@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0577167824

Study information

Scientific title

Acronym

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?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Rating of Anxiety in Dementia (RAID), QoL-AD and the General Health Questionnaire (GHQ-12)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2005

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be selected from 5 centres within North East London Mental Health Trust.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2005

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Old Age Psychiatry
Brentwood
CM15 5HQ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North East London Mental Health NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes