Contact information
Type
Scientific
Primary contact
Prof Michael King
ORCID ID
Contact details
Dept Mental Health Sciences
Royal Free Campus
Royal Free and University College Medical School
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7794 0500
m.king@medsch.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CRUK reference C1432/A4179
Study information
Scientific title
Acronym
Study hypothesis
A two-armed randomised controlled trial of the effectiveness of a 6 week intervention designed to reduce informal carer distress. Specifically, we aimed to evaluate the effects of an intervention for distressed informal carers of patients receiving specialist palliative care on:
1. Carer well-being (primary outcome)
2. Carer strain
3. Carer quality of life
4. Carer bereavement outcome
5. The proportion of patients dying at home
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
Other
Trial type
Quality of life
Patient information sheet
Condition
Informal carers of patients receiving specialist palliative care
Intervention
Six weekly visits from a carer advisor versus usual care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in carer distress as measured by General Health Questionnaire 28 (Goldberg & Williams 1988) 4, 9 and 12 weeks after randomisation.
Secondary outcome measures
1. Caregiver Strain Index: 4, 9 and 12 weeks after randomisation
2. Care-Giver Quality of Life Index (Cancer): 4, 9 and 12 weeks after randomisation
3. Carer Bereavement: 4 months after the patientsÂ’ death
Overall trial start date
01/10/2000
Overall trial end date
31/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Informal carers of patients receiving specialist palliative care
2. Able to give informed consent
3. No organic brain disease
4. over 18 years.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant exclusion criteria
1. Unable to understand English
2. Unable to give informed consent
3. Organic brain disease or dementia
4. Under 18 years of age.
Recruitment start date
01/10/2000
Recruitment end date
31/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept Mental Health Sciences
London
NW3 2PF
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)20 7679 2000
vicky.latter@royalfree.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref:C1432/A4179)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17267931
Publication citations
-
Results
Walsh K, Jones L, Tookman A, Mason C, McLoughlin J, Blizard R, King M, Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomised trial., Br J Psychiatry, 2007, 190, 142-147, doi: 10.1192/bjp.bp.106.023960.