Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000601437 |
Date of registration:
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10/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Supporting the provision of palliative care in the home environment: a proof of concept study
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Scientific title:
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Supporting the provision of palliative care in the home environment: A proof of concept study of a palliative carers education package (PrECEPt) |
Date of first enrolment:
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01/08/2016 |
Target sample size:
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22 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616000601437.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof Liz Forbat
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Address:
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Australian Catholic University
223 Antill St, Watson ACT 2602
Australia |
Telephone:
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+61 4 7597 8476 |
Email:
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Elizabeth.Forbat@acu.edu.au |
Affiliation:
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Name:
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Prof Liz Forbat
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Address:
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Australian Catholic University
223 Antill St, Watson ACT 2602
Australia |
Telephone:
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+61 4 7597 8476 |
Email:
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Elizabeth.Forbat@acu.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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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).
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.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Palliative care in the home environment; Palliative care in the home environment
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Public Health - Health promotion/education
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Intervention(s)
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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.
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Primary Outcome(s)
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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). [Baseline and immediately after intervention completion ]
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Secondary Outcome(s)
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A further bespoke questionnaire has been designed to capture core data on use and feedback on the educational materials. [Baseline and immediately after intervention completion]
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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).
[Post-intervention]
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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).[Baseline and immediately after intervention completion ]
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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.[Baseline and immediately after intervention completion ]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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ACT Health
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Ethics review
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Status: Approved
Approval date:
Contact:
Calvary Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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