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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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