Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000064707
Ethics application status
Not yet submitted
Date submitted
27/12/2012
Date registered
17/01/2013
Date last updated
17/01/2013
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
Nil
Universal Trial Number (UTN)
Nil
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
Depression
Mental Health 287926 287926 0 0
Anxiety
Public Health 287937 287937 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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
Prevention
Intervention code [2] 285847 0
Lifestyle
Intervention code [3] 285848 0
Behaviour
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Carers who: 1) are non-English speaking and 2) unable to consent.

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
7/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
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
Country [1] 286501 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Melbourne
Address
47 Victoria Parade,
Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 285287 0
None
Name [1] 285287 0
Address [1] 285287 0
Country [1] 285287 0
Other collaborator category [1] 277232 0
University
Name [1] 277232 0
The University of Melbourne
Address [1] 277232 0
Grattan St
Parkville
Victoria 3052
Country [1] 277232 0
Australia
Other collaborator category [2] 277233 0
University
Name [2] 277233 0
Australian Catholic University
Address [2] 277233 0
115 Victoria Parade
Fitzroy
Victoria 3065
Country [2] 277233 0
Australia
Other collaborator category [3] 277234 0
Government body
Name [3] 277234 0
Carers Victoria
Address [3] 277234 0
Level 1
37 Albert Street
Footscray
Victoria 3011
Country [3] 277234 0
Australia

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
Ethics committee country [1] 288576 0
Australia
Date submitted for ethics approval [1] 288576 0
06/05/2013
Approval date [1] 288576 0
Ethics approval number [1] 288576 0

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

Contacts
Principal investigator
Name 34810 0
Prof David Castle
Address 34810 0
46 Nicholson St
Fitzroy
Victoria 3065
Country 34810 0
Australia
Phone 34810 0
+61392884751
Fax 34810 0
Email 34810 0
david.castle@svhm.org.au
Contact person for public queries
Name 18057 0
Gaye Moore
Address 18057 0
46 Nicholson St
Fitzroy
Victoria 3065
Country 18057 0
Australia
Phone 18057 0
+61392882293
Fax 18057 0
Email 18057 0
gaye.moore@svhm.org.au
Contact person for scientific queries
Name 8985 0
Gaye Moore
Address 8985 0
46 Nicholson St
Fitzroy
Victoria 3065
Country 8985 0
Australia
Phone 8985 0
+61392282293
Fax 8985 0
Email 8985 0
gaye.moore@svhm.org.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.