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Trial registered on ANZCTR


Registration number
ACTRN12616000601437
Ethics application status
Approved
Date submitted
8/04/2016
Date registered
10/05/2016
Date last updated
13/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting the provision of palliative care in the home environment: a proof of concept study
Scientific title
Supporting the provision of palliative care in the home environment: A proof of concept study of a palliative carers education package (PrECEPt)
Secondary ID [1] 288924 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PrECPt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative care in the home environment 298259 0
Condition category
Condition code
Public Health 298403 298403 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feasibility Testing of PrECEPt learning materials by carers

Carers supporting someone with nutrition/hydration and pain management issues will be invited to test PrECEPt, to determine proof of concept for this novel approach to carer education.

PrECEPt is an innovative distance learning package. The package uses blended learning to present two modules (pain, and nutrition/hydration). Written materials including information, reflections and hints/tips are combined with video vignettes which illustrate care-giving scenarios, offering practical illustrations of problems and potential solutions.
The package embeds three levels of information: basic, moderate and advanced. Caregivers decide themselves how much they wish to engage and at what level with the materials.

Carers will be mailed the package and, in the covering letter, encouraged to engage with the materials over a six week period. Data will be gathered on their engagement, to document dose, intensity and amount of engagement.
Intervention code [1] 294385 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297888 0
Self-efficacy will be measured using the Ugalde tool (Ugalde et al. 2013). This is a 21 item, four factor, self-report questionniare which has been validated in cancer carers. The four factors are: resilience, self-maintenance, emotional connectivity and instrumental caregiving. Test-retest reliability and internal consistency were excellent (0.73-0.85, and 0.81-0.94 respectively).
Timepoint [1] 297888 0
Baseline and immediately after intervention completion
Secondary outcome [1] 322542 0
Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). This is a 41 item scale to measure the extent of cancer caregiving tasks and consequences, and the caregivers' needs (mainly concerning information from and communication and contact with the health care professionals) (Lund et al. 2012).
Timepoint [1] 322542 0
Baseline and immediately after intervention completion
Secondary outcome [2] 322543 0
The Preparedness for Caregiving Scale (Archbold et al. 1990). This is an eight item questionnaire that assesses how ready caregivers perceive they are for their role. Reliability was acceptable with Cronbach’s alphas ranging from 0.86 to 0.92 (Archbold and Stewart 1993). Caregiver competence refers to the perceived adequacy of an individual’s performance as a caregiver.
Timepoint [2] 322543 0
Baseline and immediately after intervention completion
Secondary outcome [3] 322544 0
A further bespoke questionnaire has been designed to capture core data on use and feedback on the educational materials.
Timepoint [3] 322544 0
Baseline and immediately after intervention completion
Secondary outcome [4] 323580 0
Post-intervention interviews will be conducted with key informant healthcare professionals (n = 4), and carers who completed the educational materials (n=16)
Interviews will elicit views on the acceptability and feasibility of the intervention; for example, eligibility criteria, method of recruitment, timing of offering the intervention in relation to the patient’s trajectory, duration of intervention. Four staff at the recruiting site will also be interviewed to gain feedback on recruitment processes, and the impact of the trial on interactions with the staff team (for example capturing information on whether more/different informational queries were received).
Timepoint [4] 323580 0
Post-intervention

Eligibility
Key inclusion criteria
Inclusion criteria for the carers taking part in the study:
(i) Recognised as the main carer for a patient receiving specialist palliative care
(ii) Supporting someone with nutrition/hydration and/or pain management needs
(iii) Aged over 18 years, and able to give informed consent
(iv) First language is English
(v) Patient’s life expectancy >12 weeks
(vi) Resident at home (not in residential aged care or receiving end-of-life care as an inpatient).

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We will exclude children and/or young people (i.e.<18) people who do not have the capacity to provide informed consent to take part in the research. Advice from the recruiting clinicians will be taken on individuals. We will also exclude people who do not have a good command of the English language, since this is a small proof of concept trial without resource to have the materials translated.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will not be used, as this is a single-group non-RCT design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is not a randomised trial, consequently there is no sequence generation required.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data from the primary and subsidiary outcome measures will be analysed using descriptive statistics. If adequate data is generated, then basic inferential statistics (t-tests) will be used to identify statistically significant changes in outcomes.

Analysis of the adherence checklist data will proceed using frequency counts to identify those areas addressed most and least frequently.

Qualitative interview data will be analysed thematically (Braun and Clarke 2006). Interviews will be digitally recorded, transcribed and managed using NVivo (version 10) software.

All data will be used to inform the refinement of the educational materials, and methodological parameters for a later scaled-up trial, including assessment of the feasibility and acceptability of the approach. Analysis of eligibility, and recruitment rates, will allow for national estimates to be calculated on number of potentially eligible carers across Australia.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 5546 0
Calvary Public Hospital ACT - Bruce
Recruitment postcode(s) [1] 13021 0
2600 - Barton

Funding & Sponsors
Funding source category [1] 293282 0
Government body
Name [1] 293282 0
ACT Health
Address [1] 293282 0
3, 11 Moore St, Canberra ACT 2601
Country [1] 293282 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
223 Antill Street, Watson, Canberra, 2602, ACT.
Country
Australia
Secondary sponsor category [1] 292130 0
None
Name [1] 292130 0
Address [1] 292130 0
Country [1] 292130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294784 0
Calvary Human Research Ethics Committee
Ethics committee address [1] 294784 0
Cnr Belconnen Way & Haydon Drive
Bruce ACT 2617
Ethics committee country [1] 294784 0
Australia
Date submitted for ethics approval [1] 294784 0
25/01/2016
Approval date [1] 294784 0
10/03/2016
Ethics approval number [1] 294784 0
2-2016

Summary
Brief summary
Families are viewed as a ‘unit of care’ in palliative services, meaning that carers’ needs are identified and addressed in order to further support the welfare of the patient. Practical educational interventions for carers are needed (Bee et al).; however it is not known which educational methods are acceptable and how high-quality information can be delivered at a national level, with limited cost implications.

A significant gap in supporting carers is determining how high-quality relevant information can be delivered at a national level, with limited cost implications, using educational methods which are acceptable to carers.

This study involves intervention development and an embedded proof of concept study.

In this study we aim to:
1. Design an innovative distance-learning educational package (PrECEPt: PalliativE Carers Education Package). Two modules, identified as priorities in the literature (pain and nutrition/hydration), will be developed.
2. Determine ideal content, learning style preferences (e.g. balance of videos/ vignettes/ quizzes), mode of delivery (online/printed), level of detail/complexity.
3. Determine the acceptability and feasibility of the educational package to carer and healthcare professionals
4. To understand the processes involved in delivery of the key components of PrECEPt including: recruitment processes for a full-scale study; data collection procedures/completion rates; queries directed to the hospice from carers involved in the feasibility work.
5. Determine sample size, recruitment and randomisation processes for a definitive trial.

We theorise that carer self-efficacy will increase through providing greater information, skills and confidence. We anticipate the education will benefit patients through more competent and supported carers.

References
Bee, P.E., Barnes, P. & Lucker, K. (2009) A systematic review of informal caregivers' needs in providing home-based end-of-life care to people with cancer. Journal of Clinical Nursing, 18(10), 1379-1393.
Trial website
Trial related presentations / publications
Forbat, L,. Haraldsdottir, E,. Lewis, M,. Hepburn, K. Supporting the provision of palliative care in the home environment: A proof of concept single arm trial of a palliative carers education package (PrECEPt). BMJ Open.
http://bmjopen.bmj.com/content/6/10/e012681.short?g=w_open_current_tab
Public notes

Contacts
Principal investigator
Name 64922 0
Prof Liz Forbat
Address 64922 0
Australian Catholic University
223 Antill St, Watson ACT 2602
Country 64922 0
Australia
Phone 64922 0
+61 475978476
Fax 64922 0
Email 64922 0
Elizabeth.Forbat@acu.edu.au
Contact person for public queries
Name 64923 0
Prof Liz Forbat
Address 64923 0
Australian Catholic University
223 Antill St, Watson ACT 2602
Country 64923 0
Australia
Phone 64923 0
+61 4 7597 8476
Fax 64923 0
Email 64923 0
Elizabeth.Forbat@acu.edu.au
Contact person for scientific queries
Name 64924 0
Prof Liz Forbat
Address 64924 0
Australian Catholic University
223 Antill St, Watson ACT 2602
Country 64924 0
Australia
Phone 64924 0
+61 4 7597 8476
Fax 64924 0
Email 64924 0
Elizabeth.Forbat@acu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary