ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001046594

Ethics application status

Approved

Date submitted

29/09/2015

Date registered

7/10/2015

Date last updated

7/10/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Improving the mental health of stroke survivors and carers: An evaluation of the Stroke and Carer Optimal Health Program (SCOHP)

Scientific title

Improving the mental health of stroke survivors and carers: An evaluation of the Stroke and Carer Optimal Health Program (SCOHP)

Secondary ID [1]

Nil

Universal Trial Number (UTN)

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 Optimal Health Program (OHP) will utilise the Collaborative Therapy Framework delivered by a OHP facilitator. SCOHP is composed of three core components adapted to suit the specific needs of the stroke survivor and the carers. This is part of a larger program of larger research study known as the Translational Research, Integrated Public Health Outcomes and Delivery (TRIPOD).

TRIPOD is a collaborative effort between three research projects aimed at understanding the efficacy and impact OHP has on the wellbeing of people with specific chronic health problems and their carers. The study of OHP with people with type I or type II diabetes has been previously registered as a trial (ACTRN12614001085662) and as with people undergoing dialysis (ACTRN12615000810516). The pilot of SCOHP was called ACCORD and registered as a trial (ACTRN12613000064707).

a) The OHP framework utilises a modular format. Each module encompasses a manualised discrete skill development intervention run over 8 weeks (plus booster session), 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 and 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. Each session with the ‘I Can Do model’ as the
core theme. It is one of the unique components of the OHP.

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.

SCOHP sessions will be conducted 1 hour per week for 8 weeks. There may be some unavoidable variation depending on participant circumstances (e.g. ill health may lead to longer break between sessions). Sessions will be conducted one-to-one and sessions are facilitated by a trained OHP facilitator. A single booster session will be conducted with participants 3 months post completion of intervention. The booster session is also one hour duration and the overall theme for this session is to address 'what is my health like now' for participants. This booster session will involve review of health plans 1, 2, and 3, consolidation of progress and reflection on achievements towards health related goals.

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 SCOHP. 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 (SCOHP) will involve baseline, 3-month, 6-month and 12-month follow-up.

OHP facilitators will receive training, and regular weekly supervision to discuss problems and minimise non-standardised activity. In addition, thematic issues will be raised at supervision meetings. OHP facilitators will also maintain session notes and attendance records for each
participant to assist with supervision and monitoring of adherence to OHP protocol.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

For stroke patients recruited from St. Vincent's Hospital:
Standard care as provided by the multidisciplinary neurology and rehabilitation teams at St Vincent’s Hospital.

For stroke patients recruited through community health organisations (e.g. National Stroke Foundation, Stroke Support Groups, Inner East Health):
Standard care will be assessed through participant responses on the Health Care Utilisation Questionnaire

Standard treatment for carers 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.

For carers the criteria is that they care for a friend or family member who's a stroke survivor for a minimum of 10 hours unpaid care per week. The stroke survivor doesn't have to live with them. Their standard care will be assessed through participant responses on the Health Care Utilisation Questionnaire.

Control group

Active

Outcomes

Primary outcome [1]

Quality of Life (AQoL 6D) – assesses health-related quality of life and health economic analysis

Timepoint [1]