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ISRCTN
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ISRCTN57412244
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ClinicalTrials.gov identifier
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Public title
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Reducing distress in carers of patients receiving specialist palliative care: a randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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CRUK reference C1432/A4179
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Study hypothesis
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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
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Informal carers of patients receiving specialist palliative care
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Participants - inclusion criteria
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1. Informal carers of patients receiving specialist palliative care
2. Able to give informed consent
3. No organic brain disease
4. over 18 years.
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Participants - exclusion criteria
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1. Unable to understand English
2. Unable to give informed consent
3. Organic brain disease or dementia
4. Under 18 years of age.
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Anticipated start date
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01/10/2000
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Anticipated end date
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31/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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280
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Interventions
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Six weekly visits from a carer advisor versus usual care
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Primary outcome measure(s)
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Change in carer distress as measured by General Health Questionnaire 28 (Goldberg & Williams 1988) 4, 9 and 12 weeks after randomisation.
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Secondary outcome measure(s)
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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 patients’ death
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Sources of funding
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Cancer Research UK (CRUK) (UK) (ref:C1432/A4179)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17267931
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Contact name
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Prof
Michael
King
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Address
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Dept Mental Health Sciences
Royal Free Campus
Royal Free and University College Medical School
Rowland Hill Street
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City/town
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London
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Zip/Postcode
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NW3 2PF
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Country
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United Kingdom
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Tel
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+44 (0)20 7794 0500
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Fax
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+44 (0)20 7830 2808
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Email
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m.king@medsch.ucl.ac.uk
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Sponsor
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University College London (UK)
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Address
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Gower Street
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City/town
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London
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Zip/Postcode
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WC1E 6BT
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Country
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United Kingdom
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Tel
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+44 (0)20 7679 2000
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Email
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vicky.latter@royalfree.nhs.uk
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Date applied
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08/09/2005
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Last edited
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21/12/2011
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Date ISRCTN assigned
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17/10/2005
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