Condition category
Mental and Behavioural Disorders
Date applied
08/09/2005
Date assigned
17/10/2005
Last edited
21/12/2011
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

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

  1. 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.

Additional files

Editorial Notes