Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001462875
Ethics application status
Approved
Date submitted
13/09/2021
Date registered
26/10/2021
Date last updated
29/09/2022
Date data sharing statement initially provided
26/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the Residential Care Transition Module improve the psychological health of family carers of people with dementia during the residential care placement process in Australia?
Scientific title
Can the Residential Care Transition Module improve dementia family carer perceived stress, anxiety, guilt, grief, depression and socioemotional support during the residential care placement process in Australia?
Secondary ID [1] 305260 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 323536 0
anxiety 323537 0
guilt 323538 0
grief 323539 0
depression 323540 0
Condition category
Condition code
Mental Health 321100 321100 0 0
Anxiety
Mental Health 321101 321101 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The psychosocial intervention is the Residential Care Transition Module (RCTM). Those allocated to the intervention group will be invited to participate in six individualised telephone- or video-counselling sessions. These will be delivered by a trained Transition Counsellor (TC; registered counsellor or psychologist, masters level or above), using a detailed intervention protocol which includes the following components:
1) Processing the carer’s experience and helping to review and validate the decision to admit their relative into RAC. Assessment of individual needs and issues for future sessions.
2) Education about dementia and the RAC environment and procedures.
3) Discussion of communication skills to support effectively working with RAC staff to provide person-centred care.
4) The impact of loss and anticipatory grief associated with the admission process, separation from a family member, and the progression of dementia.
5) Transition into new caregiving roles.
6) Any remaining residual emotional and cognitive dissonance.
The TC will provide problem-solving and coping strategies; psychological and emotional validation and support; and direction to community support and resources, as required. Each one-hour session will be tailored to the participant’s needs. To establish rapport and minimise withdrawal, the first three sessions will be scheduled weekly if possible (weeks 1, 2, 3) and every three weeks thereafter (weeks 6, 9, 12). Ad-hoc sessions will also be provided where necessary. If the carer’s relative with dementia dies during the intervention period, the TC will continue to offer the sessions to help facilitate the grief process. The intervention group will also receive printed information from Dementia Australia.
The provision of intervention sessions will be documented by the TC (date of session, time started and finished, topics covered, outcomes to follow-up for next session, any changes made and reasons for doing so) to determine “dose” of the intervention and to help inform subsequent sessions. 20% of audio-recorded sessions will be selected (with consent) to check adherence to the protocol by the Trial Manager (treatment fidelity).
Intervention code [1] 321694 0
Treatment: Other
Comparator / control treatment
The control group will receive a 15 minute check-in call from the Transition Counsellor to see if they would like any additional support e.g. details of Dementia Australia helpline, and will be sent a standardised printed information pack including information for carers about planning for placement, coping with placement, developing caring partnerships with RACF staff, self-care for carers and managing feelings, based on freely available information from Dementia Australia.
Control group
Active

Outcomes
Primary outcome [1] 328926 0
Change in carer perceived stress as measured by the Perceived Stress Scale (PSS)
Timepoint [1] 328926 0
Baseline, one month post-intervention (four months post-baseline).
Primary outcome [2] 328927 0
Change in carer anxiety as measured by the Geriatric Anxiety Inventory (GAI).
Timepoint [2] 328927 0
Baseline, one month post-intervention (four months post-baseline)
Primary outcome [3] 328928 0
Change in carer depression as measured by the Centre for Epidemiologic Studies Depression Scale (CESD).
Timepoint [3] 328928 0
Baseline, one month post-intervention (four months post-baseline).
Secondary outcome [1] 400884 0
Change in carer guilt as measured by the Caregiver Guilt Questionnaire (CGQ).
Timepoint [1] 400884 0
Baseline, one month post-intervention (four months post-baseline).
Secondary outcome [2] 400885 0
Change in carer pre-death grief as measured by the Caregiver Grief Scale (CGS).
Timepoint [2] 400885 0
Baseline, one month post-intervention (four months post-baseline).
Secondary outcome [3] 400886 0
Change in the Support for Caring subscale of the Adult Carer Quality of Life Questionnaire (ACQOL).
Timepoint [3] 400886 0
Baseline, one month post-intervention (four months post-baseline).

Eligibility
Key inclusion criteria
Any family member (related biologically or by marriage or choice) who is the primary carer of a person with dementia who has received approval from an Aged Care Assessment Team (ACAT) for permanent Residential Aged Care;
Is English-speaking with sufficient hearing ability to participate in counselling sessions;
Is over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Family carers whose family member with dementia has not yet received approval from a ACAT for permanent residential care.
Family carers who are not English speaking.
Family carers who are unable to hear sufficiently to take part in counselling sessions.
Family carers aged under 18 years.

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)
Randomisation will occur on a 1:1 basis by an independent statistician blinded to participant identification using a computer-generated allocation sequence and after baseline data has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation.
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
This is a pilot/feasibility trial, and given the known difficulties in recruiting carers of people with dementia into research studies, the target sample size for this study will be 30 (15 carers per arm).
Analyses will be performed on an intention to treat basis where the unit of analysis is the individual carer. Outcomes will be analysed using Linear Mixed Modelling techniques (LMM), with group (intervention versus control) as the between-subjects factor and time (baseline and 4 months post-baseline) as the within-subjects factor. P<0.05 will be used to indicate statistical significance (two-tailed).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
3/03/2022
Date of last participant enrolment
Anticipated
14/12/2022
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
30
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309629 0
Charities/Societies/Foundations
Name [1] 309629 0
Dementia Centre for Research Collaboration
Country [1] 309629 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Queensland University of Technology
Kelvin Grove
Brisbane QLD 4059
Country
Australia
Secondary sponsor category [1] 310648 0
None
Name [1] 310648 0
Address [1] 310648 0
Country [1] 310648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309404 0
Queensland University of Technology HREC
Ethics committee address [1] 309404 0
Ethics committee country [1] 309404 0
Australia
Date submitted for ethics approval [1] 309404 0
Approval date [1] 309404 0
15/07/2021
Ethics approval number [1] 309404 0

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

Contacts
Principal investigator
Name 114038 0
Dr Deborah Brooks
Address 114038 0
Queensland University of Technology
School of Nursing
Kelvin Grove QLD 4059
Country 114038 0
Australia
Phone 114038 0
+61 07 3138 3882
Fax 114038 0
Email 114038 0
deborah.brooks@qut.edu.au
Contact person for public queries
Name 114039 0
Deborah Brooks
Address 114039 0
Queensland University of Technology
School of Nursing
Kelvin Grove QLD 4059
Country 114039 0
Australia
Phone 114039 0
+61 07 3138 3882
Fax 114039 0
Email 114039 0
deborah.brooks@qut.edu.au
Contact person for scientific queries
Name 114040 0
Deborah Brooks
Address 114040 0
Queensland University of Technology
School of Nursing
Kelvin Grove QLD 4059
Country 114040 0
Australia
Phone 114040 0
+61 07 3138 3882
Fax 114040 0
Email 114040 0
deborah.brooks@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot and feasibility study only.


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.