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Trial registered on ANZCTR


Registration number
ACTRN12621000474853
Ethics application status
Approved
Date submitted
19/02/2021
Date registered
21/04/2021
Date last updated
31/03/2023
Date data sharing statement initially provided
21/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a support package on wellbeing of carers of people with dementia: a randomised controlled trial
Scientific title
Testing a support package on wellbeing of carers of people with dementia: a randomised controlled trial
Secondary ID [1] 303502 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 320830 0
Condition category
Condition code
Public Health 318653 318653 0 0
Health service research
Neurological 318972 318972 0 0
Dementias
Mental Health 318973 318973 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Usual care group
Carers of people with dementia may receive information and support from their geriatrician when attending clinic appointments with the person with dementia. They may also receive information and support from formal sources such as general practitioners or community aged care services, or informal sources such as Dementia Australia. [The nature of this support is likely to differ depending on the individual concerns of the person with dementia and the carer themselves, as well as the willingness of individuals to actively seek information support. Thus, standard care may slightly differ for each participant allocated to the usual care arm.]

Arm 2: Intervention group
Carers allocated to the intervention group will receive standard care (as per Arm 1) plus access to a multicomponent intervention supported by a trained Intervention Facilitator. Intervention Facilitator(s) will have a degree in health (e.g. nursing, occupational therapy, psychology or similar), be experienced in working with older people and have effective communication skills. Facilitator(s) will undergo training prior to commencing the intervention. Facilitator(s) will be asked to complete the online Dementia Practice Improvement (DPI) Series (4 hours in total; https://dementialearning.org.au/dpi-series/), which covers a range of topics that will encourage those providing dementia care to reflect on their own practice and improve their dementia knowledge and practice. Facilitator(s) will also have access to a suite of resources, including published Australian Clinical Practice Guidelines for Dementia, as well as resources from Dementia Australia (e.g. fact sheets).

Face-to-face support group sessions: Carers in this arm will be invited to attend a 1.5 hour face-to-face group session following the completion of the baseline survey, and every two months following for the duration of the study. Led by the Facilitator(s), attendees at these group sessions will include other carers enrolled in the trial (maximum 8-10 members per group). Where possible, groups will be organised according to geographical location, so that group sessions are scheduled at a location convenient to members (e.g. afternoon or evening at HMRI or private clinic of recruiting geriatrician). At the initial group session, the Facilitator will facilitate group introductions; provide information about the purpose and potential benefits of the iSupport program, the symptom checklist and the group sessions. The Facilitator will provide a hard copy and summarise the contents of the WHO iSupport manual, including the topics covered in each of the modules and the activities. The iSupport manual covers the following topics: General information about dementia; Information related to being a carer; Self-care;
Providing care for the person with dementia; and Addressing symptoms of dementia. The Facilitator will emphasise that people may have helpful tips and strategies that have worked for them in the past not listed in the resources provided, and that they are welcome to share these with others. The content of each group session will be guided by members, with the role of the Facilitator to identify areas where there may be commonalities and provide advice and support.

Monitoring and feedback of progress: Carers will be asked to complete a comprehensive assessment of symptoms of concern they have observed in the person with dementia at baseline. Throughout the 6 month intervention, carers will be invited to complete brief monthly assessments of symptoms of concern. Assessments will be completed via hard copy or an online survey, or telephone with the Facilitator according to participant preference. The repeat assessments will be used to monitor symptoms of concern identified at baseline, while also identifying new concerns that have emerged since previous assessments. Prior to each group session, the Facilitator will review the monthly assessments to identify concerns common to group members, which may be raised as part of the group discussion. The Facilitator will also conduct a follow up calls 2 weeks following each of the group sessions to discuss any issues of concern flagged and ask carers whether they have implemented any of the recommended strategies. Where any significant changes or new concerns are identified, additional or alternative management options will be recommended. A stepped care approach will be utilised, where the first option will be the least intensive (e.g. provision of iSupport booklet, bi-monthly support group). More intensive options will be reserved for those who do not benefit from first-line treatment (e.g. telephone follow-up by Facilitator, referrals to specialists for identified concerns). The Facilitator will also explore perceived barriers to adhering to recommendations, and where specific barriers are identified, suggest practical strategies to overcome these barriers.
Intervention code [1] 319791 0
Behaviour
Comparator / control treatment
Usual care - carers of people with dementia may receive information and support from a geriatrician when attending clinic appointments with the person with dementia. They may also receive information and support from formal sources such as general practitioners or community aged care services, or informal sources such as Dementia Australia.
Control group
Active

Outcomes
Primary outcome [1] 326599 0
Symptoms of depression in carers of people with dementia using a multi-component resource package compared to carers accessing usual (current) care. This will be assessed by the 20-item Centre for Epidemiologic Studies Depression Scale (CES-D).
Timepoint [1] 326599 0
Symptoms of depression will be assessed at baseline, 3 months and 6 months (primary endpoint).
Primary outcome [2] 326604 0
Burden in carers of people with dementia using a multi-component resource package compared to carers accessing usual (current) care. This will be assessed using the 12-item Zarit Burden Interview (ZBI), which measures subjective burden associated with functional/behavioural impairments and the home care situation.
Timepoint [2] 326604 0
Burden will be assessed at baseline, 3 months and 6 months (primary endpoint).
Secondary outcome [1] 392052 0
Symptoms of dementia causing concern to carers in intervention arm compared to carers accessing usual (current) care. This will be assessed using a multi-component checklist derived from validated measures of dementia symptoms (e.g. Neuropsychiatric Inventory Questionnaire) and the literature, including carer guidelines for managing behavioural-psychological symptoms of dementia. The checklist reflects both level of concern and frequency of concerning symptoms.

Timepoint [1] 392052 0
Symptoms of dementia causing concern will be assessed at baseline, 3 months and 6 months.

Eligibility
Key inclusion criteria
Eligible carers will be caring for a person with a confirmed diagnosis of dementia who has seen a geriatrician within the past 12 months, and who is aged 18 years or over, proficient in the English language and able to give informed consent. A carer is defined as an individual (e.g. relative, friend, neighbour) who takes responsibility for assisting a person with dementia. They may live with, or separately from, the person with dementia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carers of people with dementia who are living in nursing homes.

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)
An independent statistician at the Clinical Research Design, IT and Statistical Support unit of the Hunter Medical Research Institute will generate the allocation sequence via computer software.
Outcome assessors and data analysts will be blind to allocation. It is not possible to blind trial participants or the trained Intervention Facilitator delivering the intervention to allocation. Only intervention participants will have access to the resource packages. The Intervention Facilitator will be aware of trial allocation as they will be integrally involved in responding to symptom reports, including developing care plans for intervention participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly permuted blocks of size 4 will be used to allocate carers to one of the two treatment groups. The randomisation schedule will be stratified according to geriatrician..
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
For each primary outcome (burden and depression [assessed by the 20-item Centre for Epidemiologic Studies Depression Scale (CES-D)], group differences in the 6 month outcome score will be estimated using a linear mixed model using all available outcome data from 3 and 6 month follow-up. The model will include fixed effects for the baseline outcome measure, intervention group, time and the group × time interaction. The model will include a random intercept at the level of the participant to account for potential clustering of repeated outcome measures. Several potential residual correlation matrix structures will be evaluated to identify the model providing the best fit to the data. The group, time and group × time interaction terms will be used to estimate baseline-adjusted treatment group differences in the least-square means at each follow-up, with the primary comparison being at 6 months. The mixed model provides unbiased estimates of treatment effects under the assumption that data are missing at random. Sensitivity analyses such as multiple imputation and pattern mixture modelling will investigate the robustness of conclusions to different assumed models for missing data. A similar approach will be used for secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
9/12/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
300
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18761 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 22049 0
Maitland Hospital - Maitland
Recruitment postcode(s) [1] 33207 0
2305 - New Lambton
Recruitment postcode(s) [2] 37171 0
5573 - Maitland
Recruitment postcode(s) [3] 37172 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 307919 0
Government body
Name [1] 307919 0
NHMRC
Country [1] 307919 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309237 0
None
Name [1] 309237 0
Address [1] 309237 0
Country [1] 309237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307917 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 307917 0
Ethics committee country [1] 307917 0
Australia
Date submitted for ethics approval [1] 307917 0
19/02/2020
Approval date [1] 307917 0
07/04/2020
Ethics approval number [1] 307917 0
2020/ETH00403

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

Contacts
Principal investigator
Name 108922 0
Prof Rob Sanson-Fisher
Address 108922 0
HunterMedical Research Institute (HMRI)
W4, HMRI Building
University Drive
Callaghan NSW 2308
Country 108922 0
Australia
Phone 108922 0
+61 2 4042 0713
Fax 108922 0
Email 108922 0
rob.sanson-fisher@newcastle.edu.au
Contact person for public queries
Name 108923 0
Natasha Noble
Address 108923 0
HunterMedical Research Institute (HMRI)
W4, HMRI Building
University Drive
Callaghan NSW 2308
Country 108923 0
Australia
Phone 108923 0
+61 2 4042 0652
Fax 108923 0
Email 108923 0
natasha.noble@newcastle.edu.au
Contact person for scientific queries
Name 108924 0
Natasha Noble
Address 108924 0
HunterMedical Research Institute (HMRI)
W4, HMRI Building
University Drive
Callaghan NSW 2308
Country 108924 0
Australia
Phone 108924 0
+61 2 40420652
Fax 108924 0
Email 108924 0
Natasha.noble@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We are seeking advice from the Ethics Committee regarding whether raw line by line data can be shared or whether only processed data (e.g. age category rather than age; GDS total score) can be shared. Processed data may be deemed to pose less risk of identifying individuals.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (rob.sanson-fisher@newcastle.edu.au).
Depending upon advice from the Ethics Committee, either raw line by line or processed data will be made available via NOVA, the University of Newcastle's data repository.


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.