ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mental Health

Public Health

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Mean (HADS) Hospital Anxiety and Depression score

Timepoint [1]

Base line, 8 weeks, 12 weeks and 6, 12 months after randomisation.

Secondary outcome [1]

Carer Burden Inventory Score

Timepoint [1]