Reducing distress in carers of patients receiving specialist palliative care: a randomised controlled trial

ISRCTN	ISRCTN57412244
DOI	https://doi.org/10.1186/ISRCTN57412244
Secondary identifying numbers	CRUK reference C1432/A4179

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Michael King
Scientific

Dept Mental Health Sciences
Royal Free Campus
Royal Free and University College Medical School
Rowland Hill Street
London
NW3 2PF
United Kingdom

Phone	+44 (0)20 7794 0500
Email	m.king@medsch.ucl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Informal carers of patients receiving specialist palliative care
Intervention	Six weekly visits from a carer advisor versus usual care
Intervention type	Other
Primary outcome measure	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 patients death
Overall study start date	01/10/2000
Completion date	31/10/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	280
Key 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.
Key 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.
Date of first enrolment	01/10/2000
Date of final enrolment	31/10/2003

Dept Mental Health Sciences

London
NW3 2PF
United Kingdom

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)20 7679 2000
Email	vicky.latter@royalfree.nhs.uk
"ROR"	https://ror.org/02jx3x895

Charity

Cancer Research UK (CRUK) (UK) (ref:C1432/A4179)
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2007		Yes	No