Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000467437
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
8/04/2016
Date last updated
22/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Further enabling care at home for people living with dementia
Scientific title
Further Enabling Care at Home for people with dementia discharged home from hospital: A randomised controlled trial of a family carer support program
Secondary ID [1] 288788 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 298055 0
Condition category
Condition code
Neurological 298232 298232 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three steps to the intervention; each one is implemented by the Further Enabling Care at Home nurse. This nurse needs to be experienced in the care of people living with dementia and the support of their family carers and requires a background in acute care for people living with dementia with medical comorbidities. A two-day training course is also provided to familiarise the nurse with the Further Enabling Care at Home program protocols. This training is face-to-face and one-on-one; it is provided by up to three members of the investigating team with relevant expertise and covers (a) structure of the Further Enabling Care at Home program, (b) assessing caregivers' support needs, (c) identifying existing services and how these may be accessed, and (d) record keeping.

First the Further Enabling Care at Home nurse contacts the carer by telephone within 6-10 days of the discharge from hospital of the person living with dementia (ie, the care recipient). This contact is for the nurse to make a telephone appointment – during the following week - for establishing and addressing the carer’s support needs. Immediately following this, preliminary, call the nurse provides the carer with a copy of the Carer Support Needs Assessment Tool(1) to be used during the next appointment, so that the carer has time to reflect upon the questions. This first call takes approximately 10-15 minutes.
Second, the nurse telephones at the appointed time and administers the Carer Support Needs Assessment Tool(1), also addressing up to three needs identified as priorities by the carer - guiding the carer’s access to appropriate existing services. This step is supported by the Further Enabling Care at Home manual, developed during an earlier study.(2) This appointment can be expected to take at least 30 minutes and may take longer or need to involve ‘call backs’.
Finally, at two time points – 4 weeks after the discharge and 8 weeks after the discharge -the nurse telephones to check the carer’s access to services as planned, advising of alternative strategies if access has proved problematic. Each of these two sessions can be expected to last for approximately 15 minutes.

Adherence to these steps will be examined as part of process evaluation, which will also inform calculation of costs of the intervention. Each contact will be recorded in a database that records the timing of the contact with respect to the discharge date, the length of the contact, and services recommended/accessed. Barriers to/facilitators of service access will also be recorded.



1. Ewing G, Grande G. The Carer Support Needs Assessment Tool (CSNAT) for end-of-life care practice at home: A qualitative study. Palliative Medicine. 2013;27(3):244-56.
2. Toye C, Moorin R, Slatyer S, Aoun S, Parsons R, Hill, K. Protocol for randomised controlled trial of an outreach support program …BMC Geriatr June 25 2015; 15:70
Intervention code [1] 294251 0
Behaviour
Intervention code [2] 294411 0
Treatment: Other
Comparator / control treatment
Usual discharge care..
Usual discharge includes a letter from the hospital doctor to the GP (ie, family doctor - copy to patient), medications organised. ‘At risk’ carers - determined via social workers' evaluation - have social work assessment/links to services. Patients may be linked with care programs. Carers information packs are available.
Control group
Active

Outcomes
Primary outcome [1] 297718 0
The primary outcome is carers' preparedness for caregiving, to be measured with the Preparedness for Caregiving Scale (PCS)(1)

Reference:
. 1. Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Research in Nursing & Health. 1990;13(6):375-84.
Timepoint [1] 297718 0
Time 1 (T1) will be up to 5 days after discharge, T2 will be 5 weeks after discharge, T3 will be 10 weeks after discharge. Preparedness will be measured at all time points.
Secondary outcome [1] 322050 0
Carers' caregiving appraisal scores will be documented using the Family Appraisal of Caregiving Questionnaire (2)

Reference:
2. Cooper B, Kinsella GJ, et al. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care, Psychooncology 2006; 15(7):613.
Timepoint [1] 322050 0
Up to 5 days after discharge, 5 weeks after discharge, 10 weeks after discharge.
Secondary outcome [2] 322051 0
Carer health will be measured using the Optum SF-12v2 Health Survey
Timepoint [2] 322051 0
Up to 5 days after discharge, 5 weeks after discharge, 10 weeks after discharge.
Secondary outcome [3] 322052 0
Patients' emergency department attendance will be established from carers' reports
Timepoint [3] 322052 0
Within 10 weeks post-discharge
Secondary outcome [4] 322053 0
Patients' re-hospitalizations (and associated length of stay) will be established from carers' reports
Timepoint [4] 322053 0
Within 10 weeks of discharge
Secondary outcome [5] 322054 0
Patients' admissions into residential care will be established from carer reports
Timepoint [5] 322054 0
Within 10 weeks of discharge
Secondary outcome [6] 322055 0
Patients' use of ambulance services will be documented from carers' reports
Timepoint [6] 322055 0
Within 10 weeks of discharge
Secondary outcome [7] 322583 0
Experiences of the intervention
Timepoint [7] 322583 0
Carers who have experienced the intervention will be invited to participate in a qualitative exit interview after all quantitative data collection (from them) is completed. This will be at approximately 11 weeks after the discharge.
Secondary outcome [8] 322584 0
Staff perceptions of the feasibility of translation into practice
Timepoint [8] 322584 0
A focus group will be held at the end of the study (ie, after all data have been collected from carers).

Eligibility
Key inclusion criteria
Patient/carer dyads when the patient has a documented diagnosis of dementia and is being discharged from the included hospital, the discharge destination is their home or that of the family carer, and when the (family) carer can speak, read, and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient being discharged to another hospital or into residential aged care, Family carer not able to speak, read, and understand 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)
Group allocation not known to staff undertaking recruitment. The allocation involved contacting the holder of the allocation schedule at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation of blocks of numbers that are also randomly selected using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Carers receiving the intervention will be interviewed to investigate feasibility/usefulness, a staff focus group will address the feasibility of translation into practice. Process evaluation will establish fidelity, carer resources accessed, barriers/facilitators related to access. Process evaluation will also inform economic analyses.
Phase
Type of endpoint/s
Statistical methods / analysis
Intention to Treat regression analyses for patients and carers. The primary outcome is the total score on the Preparedness for Caregiving Scale(1 ). An improvement of 2 points in this score is clinically relevant, given that this would mean a change such as progressing to ‘very well prepared’ from ‘well prepared’ in 25% of items. To detect a change of this magnitude with 80% power, assuming that the standard deviation of the change in mean score is approximately 0.5, as in previous work(2), 63 dyads per group will be required. Based upon our previous studies, we expect attrition of 20%, so will recruit 154 carers.

Cost consequence analysis related to costs of implementing the intervention and any changes in costs of health service use for patients in the 10-week post-discharge period.

Thematic analysis of qualitative data.(recruitment until data saturation).
1. Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Research in Nursing & Health. 1990;13(6):375-84.
2. Henriksson A, Andershed B, et al. Adaptation & psychometric evaluation of the Preparedness for Caregiving Scale …. Palliative Medicine. 2012;26(7):930.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/05/2016
Actual
Date of last participant enrolment
Anticipated
30/03/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
308
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293168 0
Self funded/Unfunded
Name [1] 293168 0
Funding being sought
Country [1] 293168 0
Primary sponsor type
Individual
Name
Christine Toye
Address
Curtin University, Kent St, Bentley Western Australia 6102
Country
Australia
Secondary sponsor category [1] 291963 0
None
Name [1] 291963 0
Address [1] 291963 0
Country [1] 291963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294659 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 294659 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, Western Australia, 6009
Ethics committee country [1] 294659 0
Australia
Date submitted for ethics approval [1] 294659 0
16/03/2016
Approval date [1] 294659 0
26/04/2016
Ethics approval number [1] 294659 0
Ethics committee name [2] 297264 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 297264 0
GPO Box U1987, Perth WA 6845
Ethics committee country [2] 297264 0
Australia
Date submitted for ethics approval [2] 297264 0
03/05/2016
Approval date [2] 297264 0
04/05/2016
Ethics approval number [2] 297264 0
83/2016

Summary
Brief summary
Negative outcomes for the person living with dementia and their family carer can be anticipated from inadequate carer support. The Further Enabling Care at Home program involves systematic assessment of the carer’s support needs plus guidance to access existing services. We aim to test this program with family carers of people with dementia upon hospital discharge.
Objectives are to:
1. Test how well the Further Enabling Care at Home program supports preparedness to care – and subsequent caregiving sustainability - in family carers of people living with dementia.
2. Determine the feasibility of translating the program into routine practice.
Hypotheses for this study are that the program will help prepare families to sustain their caregiving role and reduce hospital/residential care use by the people with dementia receiving their care; also that costs of providing the program will be outweighed by savings.
Research plan
The 154 included dyads will each comprise a person living with dementia being discharged home from hospital and their family carer. In a single-blind randomised controlled trial, dyads will be assigned to receive either usual care or usual care plus the new program. Data will be collected from all carers at discharge, 5 weeks post-discharge, and 10 weeks post-discharge using questionnaires administered over the telephone.
The primary outcome evaluated for carers is their preparedness to provide care. Carer data will establish patients’ use of health/residential services during the 10-week period. Intention-to-treat regression analyses will determine differences in carer and patient outcomes over time associated with group assignment. Cost consequence analyses plus qualitative and process evaluations will further inform recommendations for translation into practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64478 0
A/Prof Christine Toye
Address 64478 0
School of Nursing, Midwifery and Paramedicine
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country 64478 0
Australia
Phone 64478 0
+61 8 9266 1756
Fax 64478 0
Email 64478 0
[email protected]
Contact person for public queries
Name 64479 0
A/Prof Christine Toye
Address 64479 0
School of Nursing, Midwifery and Paramedicine
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country 64479 0
Australia
Phone 64479 0
+61 8 9266 1756
Fax 64479 0
Email 64479 0
[email protected]
Contact person for scientific queries
Name 64480 0
A/Prof Christine Toye
Address 64480 0
School of Nursing, Midwifery and Paramedicine
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country 64480 0
Australia
Phone 64480 0
+61 8 9266 1756
Fax 64480 0
Email 64480 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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