Reducing distress in carers of patients receiving specialist palliative care: a randomised controlled trial
| ISRCTN | ISRCTN57412244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57412244 |
| Protocol serial number | CRUK reference C1432/A4179 |
| Sponsor | University College London (UK) |
| Funder | Cancer Research UK (CRUK) (UK) (ref:C1432/A4179) |
- Submission date
- 08/09/2005
- Registration date
- 17/10/2005
- Last edited
- 21/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael King
Scientific
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 |
|---|---|
| m.king@medsch.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Change in carer distress as measured by General Health Questionnaire 28 (Goldberg & Williams 1988) 4, 9 and 12 weeks after randomisation. |
| Key secondary outcome measure(s) |
1. Caregiver Strain Index: 4, 9 and 12 weeks after randomisation |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dept Mental Health Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2007 | Yes | No |
