Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000621314
Ethics application status
Approved
Date submitted
11/09/2008
Date registered
8/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving the psychological wellbeing of family caregivers of home based palliative care patients: A randomised controlled trial
Scientific title
Evaluating the effect of carer education and support from a palliative care nurse on the psychological wellbeing of family caregivers of home based palliative care patients: A randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General wellbeing / Grief 3673 0
Carer Preparedness 3674 0
Condition category
Condition code
Mental Health 3839 3839 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three sessions with a palliative care nurse to provide carers with education and support relating to the role of caring for someone receiving home based palliative care. Sessions are approximately one hour in length and are conducted weekly. During the sessions, carers are provided with a resource pack which includes a family carer guidebook, a relaxation CD, and relevant service brochures. In addition, the nurse also assesses carer needs and develops a care plan to address carer needs.
Intervention code [1] 3388 0
Behaviour
Comparator / control treatment
No treatment but access to all of the usual carer services including nursing care and allied health care.
Control group
Active

Outcomes
Primary outcome [1] 4737 0
General wellbeing (General Health Questionnaire)
Timepoint [1] 4737 0
T1 (admission), T2 (5 weeks later) and T3 (3 months post bereavement)
Primary outcome [2] 4738 0
Grief (Core Bereavement Index)
Timepoint [2] 4738 0
T3 (3 months post bereavement)
Primary outcome [3] 4739 0
Carer competence (Caregiving Competence Scale) and preparedness (Preparedness for Caregiving Scale)
Timepoint [3] 4739 0
T1 (admission) and T2 (5 weeks later)
Secondary outcome [1] 8002 0
Unmet Care Needs (Family Inventory of Needs)
Timepoint [1] 8002 0
T1 (admission) and T2 (5 weeks lateer)

Eligibility
Key inclusion criteria
Primary carers of patients who are admitted to home based community palliative care services. Patients must have cancer and a primary caregiver/next of kin (NOK). Carers must be over 18 years and be able to read and write English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not have cancer and/or do not have a primary caregiver/NOK. Carers who are unable to read and write English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following completion of time 1 data collection, participants are asked to pick an ID number out of an envelope (containing all possible numbers). Each ID number has been pre-allocated to a group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pulling a number out of an envelope is completely by chance.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1145 0
3068
Recruitment postcode(s) [2] 1342 0
2800
Recruitment postcode(s) [3] 1343 0
6017

Funding & Sponsors
Funding source category [1] 3854 0
Government body
Name [1] 3854 0
National Health and Medical Research Council (NHMRC)
Country [1] 3854 0
Australia
Primary sponsor type
Hospital
Name
Centre for Palliative Care Education and Research, St Vincent's Hospital
Address
PO Box 2900
Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 3513 0
None
Name [1] 3513 0
Address [1] 3513 0
Country [1] 3513 0
Other collaborator category [1] 409 0
University
Name [1] 409 0
WA Centre for Cancer and Palliative Care
Curtin University
Address [1] 409 0
Health Research Campus
GPO Box U1987
Perth, WA 6845
Country [1] 409 0
Australia
Other collaborator category [2] 410 0
University
Name [2] 410 0
Centre for Rural and Remote Mental Health
University of Newcastle
Address [2] 410 0
Locked Bag 6005
Orange, NSW 2800
Country [2] 410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5906 0
St Vincent's Hospital Human Ethics Committee
Ethics committee address [1] 5906 0
Ethics committee country [1] 5906 0
Australia
Date submitted for ethics approval [1] 5906 0
Approval date [1] 5906 0
31/01/2008
Ethics approval number [1] 5906 0
HREC-A 095/07

Summary
Brief summary
This study will examine the effectiveness of a psycho-educational intervention aimed at promoting coping and psychological wellbeing in family caregivers caring for a relative receiving home based palliative care. The intervention will be offered in a full version (two home visits and one phone call) and the 'rural' format (one home visit and two phone calls). The main hypotheses are:
1. Primary family caregivers who receive the intervention will report: increased perceived competence for their caregiving role; increased perceived preparedness for their caregiving role; increased positive emotions associated with their role; decreased unmet informational needs; decreased levels of psychological distress, when compared with caregivers in the control group one week after the intervention.
2. Family caregivers receiving the intervention will report decreased levels of psychological distress when compared to controls 3 months following bereavement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28921 0
Address 28921 0
Country 28921 0
Phone 28921 0
Fax 28921 0
Email 28921 0
Contact person for public queries
Name 12078 0
Dr Peter Hudson
Address 12078 0
Centre for Palliative Care Education and Research
PO Box 2900
Fitzroy, VIC 3065
Country 12078 0
Australia
Phone 12078 0
+61 3 94160000
Fax 12078 0
+61 3 94163919
Email 12078 0
[email protected]
Contact person for scientific queries
Name 3006 0
Dr Peter Hudson
Address 3006 0
Centre for Palliative Care Education and Research
PO Box 2900
Fitzroy VIC 3065
Country 3006 0
Australia
Phone 3006 0
+61 3 94160000
Fax 3006 0
+61 3 94163919
Email 3006 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.