Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/04/2015
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 Daya Pandita-Gunawardena

ORCID ID

Contact details

Geriatric Secretaries
University Hospital Lewisham
Waterloo Block
Lewisham High Street
London
SE13 6LH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0124148627

Study information

Scientific title

An audit to examine the effectiveness of information and counselling strategies in relieving caregiver stress in caregivers of patients with dementia

Acronym

Study hypothesis

Does enhanced carer counselling improve the quality of life, relieve caregiver stress and improve clinical practice, compared with routine counselling?

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

Quality of life

Patient information sheet

Condition

Nervous System Diseases: Alzheimer's disease

Intervention

Patients will be randomised into two groups. One will receive routine counselling and the other enhanced. Groups assessment results will be compared.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Zait Burden interview (caregiver)

Secondary outcome measures

Medication use/Medication Resource Use (Patient and Caregiver)

Overall trial start date

30/07/2004

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

100 newly diagnosed patients with Alzheimer's disease and their caregivers referred to the memory clinic.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant exclusion criteria

Any concomitant medical condition in patient/carer which would confound interpretation of impact of Alzheimer's disease

Recruitment start date

30/07/2004

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Lewisham
London
SE13 6LH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

University Hospital Lewisham NHS Trust (UK), NHS R&D Support Funding

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