A short-term group intervention for informal carers of palliative care patients: feasibility and pilot study of a randomised controlled trial
| ISRCTN | ISRCTN86241808 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86241808 |
| Protocol serial number | RDC01028 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 07/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Irene Higginson
Scientific
Scientific
Department of Palliative Care and Policy
Guy's, King's and St Thomas' School of Medicine
King's College London
Cutcombe Road
London
SE5 9RJ
United Kingdom
| Phone | +44 (0)20 7848 5584 |
|---|---|
| irene.higginson@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This study is investigating the needs of carers of patients with advanced illness. It will determine whether a support group for carers is feasible, acceptable and accessible and will develop and pilot methods for its evaluation in a randomised controlled trial. Such a support group was found to be effective in one study in the US; it improved patient and carer outcomes and increased time at home. However, such a service has not been tested in this country in any rigorous evaluation. The study is based in two specialist palliative care services, both of which offer multi-professional specialist palliative home care support. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pain; palliative care |
| Intervention | Standard care vs short-term intervention |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Zarit Burden Inventory |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Key inclusion criteria | Nearest carers of patients with advanced and terminal disease (mainly cancer patients but some will have other progressive diseases such as neurological or cardiovascular disease's) in the care of palliative care services at the Camden and Islington Palliative Care Centre, London and St Christopher's Hospice, London. Patients will usually be in the last months of life - average time in care of the services is 12-18 weeks. Patients and carers from a wide range of ethnic and social backgrounds. 75% are 65 years of age or older. |
| Key exclusion criteria | 1. Younger than 18 years 2. Lack of fluent english 3. Prognosis less than 3 weeks |
| Date of first enrolment | 01/02/1999 |
| Date of final enrolment | 01/02/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Palliative Care and Policy
London
SE5 9RJ
United Kingdom
SE5 9RJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2002 | Yes | No |
