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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the mental health of carers of stroke patients
Scientific title
Randomised controlled trial to evaluate the impact of a self-management program on the mental health of carers of stroke patients
Secondary ID [1] 281372 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 287595 0
Public Health 287597 0
Condition category
Condition code
Mental Health 287925 287925 0 0
Mental Health 287926 287926 0 0
Public Health 287937 287937 0 0
Health promotion/education

Study type
Description of intervention(s) / exposure
The self-management program called ACCORD will utilise the Collaborative Therapy Framework delivered by a clinical care coordinator (CLT). ACCORD is composed of three core components adapted to suit the specific needs of the carer:
a) The framework utilises a modular format. Each module encompasses a manualised discrete skill development intervention run over 12 weeks, one hour in duration, one on one, conducted by a trained health professional, involving: health promotion, interagency collaboration, accessible support care coordinator, information about stroke and resources, understanding stress, family and community support and caring relation to stroke. The modular format allows for tailoring of the intervention to suit the needs of carers of stroke survivors at various stages of the illness. Similarity across modules in terms of the core intervention, plus overlap between modules, enhances implementation through familiarity with the methods and style. This also addresses efficiency and cost-effectiveness with respect to training staff.
b) Self-efficacy of the carer is a pivotal part of the process and is taught using a systematic approach to both clinicians and consumers with each module, regardless of content, delivers education, coping strategies, skills development and adaptation paradigms. This supports the philosophy that a person’s illness should not be ‘dependent on’ but ‘supported by’ the services they need to utilise.
c) Smooth integration from acute through to community care is paramount. Therapeutic and systemic collaboration with consumers and clinicians will be an integral part of the process. These parties will inform both the content of the group intervention and its integration into existing service structures.
Post-intervention focus groups, with clinicians (nurses, physicians, GP’s and mental health workers) and with consumers will be conducted to assist in the evaluation of ACCORD. The focus groups will be for two hours facilitated by two investigators exploring the views of health professionals, carers and survivors of stroke. There will be an opportunity for the investigators to report the findings of the project as well as record the opinions and experiences of the participants.
The individualised Collaborative Therapy program (ACCORD) will involve 3-month, 6-month and 12-month follow-up and care coordination over a 4-year period.
Intervention code [1] 285846 0
Intervention code [2] 285847 0
Intervention code [3] 285848 0
Comparator / control treatment
Standard treatment will include the current discharge planning that operates in the acute and subacute units of the hospital, incorporating referrals to allied health, community support and other clinically appropriate referrals. The length of treatment will vary from person to person according to the severity of their illness and treatment required. Inpatient rehabilitation is a standard treatment option for stroke survivors but not always required.
Control group

Primary outcome [1] 288146 0
Mean (HADS) Hospital Anxiety and Depression score
Timepoint [1] 288146 0
Base line, 8 weeks, 12 weeks and 6, 12 months after randomisation.
Secondary outcome [1] 299499 0
Carer Burden Inventory Score
Timepoint [1] 299499 0
Baseline, 8 weeks, 12 weeks, and 6 and 12 months after randomisation.
Secondary outcome [2] 299500 0
Carer Strain Score
Timepoint [2] 299500 0
Baseline, 8 weeks, 12 weeks, and 6 and 12 months after randomisation.
Secondary outcome [3] 299501 0
AQOL Score - Quality of Life
Timepoint [3] 299501 0
Baseline, 8 weeks, 12 weeks, and 6 and 12 months after randomisation.
Secondary outcome [4] 299502 0
General Self Efficacy Scale score
Timepoint [4] 299502 0
Baseline, 8 weeks, 12 weeks, and 6 and 12 months after randomisation.
Secondary outcome [5] 299503 0
The Preparedness for Caregiving Scale score
Timepoint [5] 299503 0
Baseline, 8 weeks, 12 weeks, and 6 and 12 months after randomisation.

Key inclusion criteria
Patients aged 18 years and older with transient ischaemic attack (TIA) or completed stroke (cerebral infarction or parenchymal haemorrhage), as confirmed by CT scan. To enter this study, all stroke patients must have an informal carer. The carer will be an unpaid support person who offers at least 10 hours of care a week and is nominated by the stroke survivor.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Carers who: 1) are non-English speaking and 2) unable to consent.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed as the investigator who decides on the eligibility of the participant will not know to which group the subject is allocated. The allocation will be conducted with a sealed opaque envelope and the allocation scheduled will be held in locked files.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation of equal number of subjects to treatment and control groups will be conducted. Patients at St Vincent’s Hospital will be identified by diagnosis according to inclusion criteria and recruited over a 24-month period. After recruitment and consent to be involved in the trial the patient and carer will be randomised by computer generated number system to either the treatment or control group. Assessors and analysers of the results will be blinded to the randomisation process and will not know who is in the control or treatment group. Randomised computer generated number system to either the treatment or control group will be created.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Economic Evaluation
A full economic evaluation will occur alongside the proposed RCT. Both health outcomes and costs will be compared between groups from the perspective of the health care system. In addition to the health outcome measures, the utility measurement of quality of life of the survivor and the informal carer(s) will be assessed using AQoL-6D developed in Australia. The potential long term (life time) impact on cost and effectiveness of intervention beyond the trial period will be extrapolated using the Markov process modelling method.
Statistical Analysis
T-tests and analysis of covariance (ANCOVA) will be used to test for statistically significant difference between the treatment groups at 6 and 12 months. The control group will be used as the reference group in the ANCOVA and the p value associated with the treatment group variable will be used to determine the success of the trial. The treatment will be considered statistically significantly better than usual care if the p value is less than 0.05.The economic evaluation will use ICER (incremental Cost-Effectiveness Ratio) and will be based on the Australian Standard of acceptance.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 341 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 342 0
St George's Health Service - Kew
Recruitment postcode(s) [1] 6139 0
3065 - Fitzroy
Recruitment postcode(s) [2] 6141 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 286501 0
Self funded/Unfunded
Name [1] 286501 0
Address [1] 286501 0
Country [1] 286501 0
Primary sponsor type
St Vincent's Hospital, Melbourne
47 Victoria Parade,
Victoria 3065
Secondary sponsor category [1] 285287 0
Name [1] 285287 0
Address [1] 285287 0
Country [1] 285287 0
Other collaborator category [1] 277232 0
Name [1] 277232 0
The University of Melbourne
Address [1] 277232 0
Grattan St
Victoria 3052
Country [1] 277232 0
Other collaborator category [2] 277233 0
Name [2] 277233 0
Australian Catholic University
Address [2] 277233 0
115 Victoria Parade
Victoria 3065
Country [2] 277233 0
Other collaborator category [3] 277234 0
Government body
Name [3] 277234 0
Carers Victoria
Address [3] 277234 0
Level 1
37 Albert Street
Victoria 3011
Country [3] 277234 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288576 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 288576 0
47 Victoria Parade
Victoria 3065
Ethics committee country [1] 288576 0
Date submitted for ethics approval [1] 288576 0
Approval date [1] 288576 0
Ethics approval number [1] 288576 0

Brief summary
Stroke is a disease with severe consequences for the survivor and the unexpected carer. Carers experience tremendous changes and challenges from role reversal to financial struggle and subsequent increased burden, low mood, and poor overall health. In Australia, there are approximately 60,000 new strokes per year; a decrease in stroke mortality as a result of improvements in medical and surgical management mean people are living longer with the residues of stroke, and that carers increasingly face long-term burden. Eighty percent of individuals who experience stroke return home with varying degrees of neurological, behavioural and psychological symptoms. At home, they often rely on informal carers for their physical and emotional support. Previous psychosocial interventions to support informal carers of stroke survivors have shown promising results; however none have sought to integrate carer interventions with care coordination. To address this, the Australian Care Coordination program (ACCORD) has combined a 12-week individualised Collaborative Therapy with 3-month, 6-month and 12-month follow-up and care coordination in a 4-year study. This research will assess the feasibility and cost-effectiveness of improving the mental and physical health, social connectedness and health service utilisation of the carers of stroke as well as stroke survivors. This model will be designed with the intention of being readily adapted and applied in the context of other physical and also mental diseases. The findings of this randomised control trial will investigate the impact of ACCORD on reducing carer depression, burden and emotional stress.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34810 0
Prof David Castle
Address 34810 0
46 Nicholson St
Victoria 3065
Country 34810 0
Phone 34810 0
Fax 34810 0
Email 34810 0
Contact person for public queries
Name 18057 0
Dr Gaye Moore
Address 18057 0
46 Nicholson St
Victoria 3065
Country 18057 0
Phone 18057 0
Fax 18057 0
Email 18057 0
Contact person for scientific queries
Name 8985 0
Dr Gaye Moore
Address 8985 0
46 Nicholson St
Victoria 3065
Country 8985 0
Phone 8985 0
Fax 8985 0
Email 8985 0

No information has been provided regarding IPD availability
Summary results
No Results