Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000918729
Ethics application status
Approved
Date submitted
14/08/2013
Date registered
20/08/2013
Date last updated
16/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing support needs of carers in palliative care
Scientific title
Implementing and evaluating the impact of the Carer Support Needs Assessment Tool (CSNAT) in community palliative care
Secondary ID [1] 283019 0
nil
Universal Trial Number (UTN)
Trial acronym
CSNAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 289848 0
public health 289849 0
Condition category
Condition code
Mental Health 290205 290205 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 290206 290206 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CSNAT is used to elicit carer concerns in a systematic way.It has two sets of items administered together on the form and it takes 15 minutes to complete the form. The CSNAT is administered by the nurse face to face during the home visit:
- the first set covers support that enables the carer to care for the patient at home, such as understanding the patient’s illness; knowing what to expect in the future; knowing who to contact; managing symptoms and medicines; providing personal care (dressing and toileting); equipment; talking to care recipient about his or her illness.
- the second set covers support for the carer in their caring role, such as looking after own health; dealing with feelings and worries; practical help; emotional support and respite.
A stepped wedge design (explained under design section) to assess the impact of the intervention, an intervention group using CSNAT and a control group using standard care, with 220 carers in each group (total 440 carers). Data collection will span over 2 years.
Intervention code [1] 287735 0
Prevention
Comparator / control treatment
standard treatment means there is no CSNAT form to complete.
Control group
Active

Outcomes
Primary outcome [1] 290230 0
quality of life as measured by SF12
Timepoint [1] 290230 0
baseline, at 4 weeks during caring journey and then at 3 months post bereavement.
Primary outcome [2] 290231 0
caregiver strain and distress as measured by FACQ-PC
Timepoint [2] 290231 0
baseline, 4 weeks from baseline
Secondary outcome [1] 304180 0
grief as measured by TRIG
Timepoint [1] 304180 0
3 months post bereavement

Eligibility
Key inclusion criteria
Inclusion criteria: Resident carer (co-habiting); patients and carers are adults; carer reads and writes English; carer has no cognitive impairment; patient with cancer and non-cancer diagnoses.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carer cannot read or write English, Carer has cognitive impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A stepped wedge design or multiple baseline methodology is used to trial this intervention, where sites start using the intervention at different time points (stepped sequence). allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All bases will initially collect data at all measurement points from carers (control). This data collection before the intervention will provide a ‘baseline’ understanding of the underlying trends i.e. changes in the outcome measures as the patient deteriorates and become more dependent on palliative care and any departmental and cyclical (e.g. seasonal) effects to be estimated. Rather than randomizing individual carers to the intervention group, sites or bases will be randomly selected to commence using the intervention at different time points after collection of control data.
stratified allocation by centre or nursing base.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
all participants in the three nursing bases are controls, and then the intervention is introduced one base at a time every three months until all participants in the three bases are in the intervention group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis: Data will be analysed using the SPSS statistical software package. Analyses will include standard descriptive statistics, independent and paired two-tailed Student’s t-tests, and two-way repeated measures (group x time) analysis of variance. All tests will be two-tailed and an alpha level of 0.05 set as the criterion for statistical significance.
Carer outcomes between the two groups (intervention and control) will be compared using univariate analyses. Recruitment bias will be assessed by comparing demographic and clinical variables for participants with those who decline participation using t-tests or Mann-Whitney U tests for continuous variables and chi-squared tests for categorical variables. Possible differential attrition will be assessed by comparing baseline characteristics of those who withdraw with those who remain in the study using t-tests or Mann-Whitney U tests for continuous variables and chi-squared tests for categorical variables.

Sample Size Requirements and Power calculation:
Previous research has found that carers who felt psychologically unsupported during caregiving report worse mental health post bereavement (effect size 0.67). Assuming a more modest effect size of 0.41for the primary measure, a sample size of 95 in each group (intervention and control) would give 80% power to demonstrate an effect of the intervention at alpha <0.05, two-tailed test between two independent groups. In order to achieve a total of 190 carers, we will need to recruit 63 carers from each site to complete measurements at all time points (including 3 months post bereavement).

Traditional statistical methods rely on the assumption of independent observations. Since the intervention is to be delivered by the same staff at each base, independence of carer responses within each site cannot be assumed and ignoring this site-level clustering will result in tests with Type 1 errors greater than a nominal level of 5% and p-values that overstate the significance of the results. Therefore a design effect has been incorporated into our sample size calculation. This effect is calculated as 1+(K-1) ICC, where K=63 average number of carers per site and ICC = 0.01. Thus, the required sample size is 95x1.62=154 carers per group. The required final sample size of 308 carers or about 100 carers per base, as calculated above for the primary outcome measure, will allow us to test for effect sizes of the same magnitude for the secondary outcomes.

We estimate that there will be a 30% attrition rate overall. This implies that 308/0.70 = 440 carers are needed at the pre-intervention measurement data collections or 220 carers in each group (intervention and control). In order to achieve this, each of the three bases will need to recruit about 147 carers over 15 months, this means on average 37 patients per timeband per cluster. These sample sizes are very feasible based on the fact that on average 200 new patient referrals are received per month.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/03/2012
Actual
6/03/2012
Date of last participant enrolment
Anticipated
6/03/2012
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1441 0
Silver Chain

Funding & Sponsors
Funding source category [1] 287782 0
Government body
Name [1] 287782 0
Australian Research Council
Country [1] 287782 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 286510 0
Other
Name [1] 286510 0
Silver Chain
Address [1] 286510 0
Silver Chain House
6 Sundercombe St
Osborne Park WA 6017
Country [1] 286510 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289731 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289731 0
Ethics committee country [1] 289731 0
Australia
Date submitted for ethics approval [1] 289731 0
Approval date [1] 289731 0
13/05/2011
Ethics approval number [1] 289731 0
HR 24/2011
Ethics committee name [2] 289732 0
Silver Chain Research Ethics Committee
Ethics committee address [2] 289732 0
Ethics committee country [2] 289732 0
Australia
Date submitted for ethics approval [2] 289732 0
Approval date [2] 289732 0
27/02/2012
Ethics approval number [2] 289732 0
SC 068

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42154 0
Prof Samar Aoun
Address 42154 0
School of Nursing and Midwifery
Curtin University
GPO Box U1987
Perth WA 6845
Country 42154 0
Australia
Phone 42154 0
+61419911940
Fax 42154 0
Email 42154 0
[email protected]
Contact person for public queries
Name 42155 0
Samar Aoun
Address 42155 0
School of Nursing and Midwifery
Curtin University
GPO Box U1987
Perth WA 6845
Country 42155 0
Australia
Phone 42155 0
+61419911940
Fax 42155 0
Email 42155 0
[email protected]
Contact person for scientific queries
Name 42156 0
Samar Aoun
Address 42156 0
School of Nursing and Midwifery
Curtin University
GPO Box U1987
Perth WA 6845
Country 42156 0
Australia
Phone 42156 0
+61419911940
Fax 42156 0
Email 42156 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

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