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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] 287560 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 296340 0
Public Health 296341 0
Condition category
Condition code
Mental Health 296615 296615 0 0
Depression
Mental Health 296616 296616 0 0
Anxiety
Public Health 296617 296617 0 0
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] 292957 0
Prevention
Intervention code [2] 292958 0
Lifestyle
Intervention code [3] 292959 0
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] 296227 0
Quality of Life (AQoL 6D) – assesses health-related quality of life and health economic analysis
Timepoint [1] 296227 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Primary outcome [2] 296228 0
General Self-Efficacy Scale (GSES) – Perceived self-efficacy in response to daily challenges and stressful life events
Timepoint [2] 296228 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Primary outcome [3] 296303 0
EuroQoL (EQ-5D-3L) – assesses health-related quality of life and health economic analysis
Timepoint [3] 296303 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [1] 317882 0
Carers' Assessment of Satisfaction Index (CASI) - for carers only
Timepoint [1] 317882 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [2] 317883 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 317883 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [3] 317884 0
Ten Item Personality Inventory
Timepoint [3] 317884 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [4] 317885 0
Brief Illness Perceptions Questionnaire - for stroke survivors only
Timepoint [4] 317885 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [5] 317886 0
Brief COPE (coping styles)
Timepoint [5] 317886 0
Baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [6] 318129 0
Modified Caregiver Strain Index (MCSI) measures carer strain - for carers only
Timepoint [6] 318129 0
Baseline, 3 months, 6 months, and 12 months after randomisation.

Eligibility
Key inclusion criteria
Stroke survivors aged 18 years and older who have experienced a stroke as diagnosed by a medical professional.

The carer of a stroke survivor will be an unpaid support person who offers at least 10 hours of care per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carers and stroke survivors 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)
A simple randomisation of equal number of subjects to treatment and control groups will be conducted. Patients and carers will be informed of the study by a research clinician working in conjunction with St Vincent's staff. Patients will also be recruited through community health organisations (e.g., National Stroke Foundation, Stroke Association Victoria) and provided with contact details to obtain further information about the study and ask questions.

Potential participants will be approached for consent and if agreeing to participate and meet inclusion criteria, will be randomised by computer generated number system to either treatment or control condition. Allocation will be concealed via method of central randomisation via computer. Consenting participants will be randomly assigned via block randomisation computerised sequence to be treated in either the intervention group, or the control group which will receive the Stroke and Carer Optimal Health Program (SCOHP) at the end of 12 months. The decision to assign will not be up to any clinician or researcher but rather a computer programme that will select numbers at random. The intervention group will receive the OHP comprising eight 1 hour sessions (and a booster session). For control and intervention group participants, baseline, three, six, and 12 month follow up will occur during which participants will complete a questionnaire.

CONSORT procedures will be followed: researchers completing the data analysis will be blind to intervention allocation and intention-to-treat analyses will be applied. The allocation sequence will be generated using random numbers. Patients will be randomised progressively as they are consented and complete baseline assessment.

Due to the variability of standard care, all participants will complete the Health Utilisation Questionnaire at baseline, 3, 6 and 12 month follow-up points to map key aspects of standard care at each unit of each site.

OHP facilitators will receive training, and regular supervision to discuss problems and minimise non-standard activity.
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.

Power was calculated to detect a medium effect size of Cohen's d = 0.50. This was chosen as a clinically meaningful effect size that may be compared with previous RCT research in the area of chronic disease management programs. Calculations assumed two primary outcomes (health related quality of life and GSES scores), four assessment points (baseline, 3-month, 6-month, and 12-month), a study-wide Type I error rate (alpha) of .05, and hence a Type II error rate (beta) of .20 (power of .80), a correlation of post-treatment scores with baseline measurements (Spearman's Rho or r) of 0.81, and a two-tailed statistical test. To detect an effect size of Cohen's d = 0.50, 53 participants in each of the control and intervention groups will be required. Allowing for up to 20% attrition, a total of 168 participants, or 42 carers and stroke survivors in control and intervention groups is required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/05/2015
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4393 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 4394 0
St George's Health Service - Kew
Recruitment postcode(s) [1] 10613 0
3065 - Fitzroy
Recruitment postcode(s) [2] 10614 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 292133 0
Government body
Name [1] 292133 0
Australian Government’s Collaborative Research Networks (CRN) program
Country [1] 292133 0
Australia
Funding source category [2] 292178 0
University
Name [2] 292178 0
Australian Catholic University Research Funding (ACURF)
Country [2] 292178 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] 290811 0
Hospital
Name [1] 290811 0
St George's Health Service, Melbourne
Address [1] 290811 0
283 Cotham Road, Kew VIC 3101
Country [1] 290811 0
Australia
Other collaborator category [1] 278644 0
University
Name [1] 278644 0
The University of Melbourne
Address [1] 278644 0
Grattan St
Parkville
Victoria 3052
Country [1] 278644 0
Australia
Other collaborator category [2] 278645 0
University
Name [2] 278645 0
Australian Catholic University
Address [2] 278645 0
Centre for the Heart and Mind
Level 5, 215 Spring St, Melbourne VIC 3000
Country [2] 278645 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293613 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 293613 0
Ethics committee country [1] 293613 0
Australia
Date submitted for ethics approval [1] 293613 0
Approval date [1] 293613 0
21/04/2015
Ethics approval number [1] 293613 0
HREC A 031/12

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

Contacts
Principal investigator
Name 60662 0
Prof David Castle
Address 60662 0
Mental Health Services
St Vincent's Hospital
46 Nicholson St,
Fitzroy,
Victoria 3065
Country 60662 0
Australia
Phone 60662 0
+61392884751
Fax 60662 0
Email 60662 0
[email protected]
Contact person for public queries
Name 60663 0
Rachel Haselden
Address 60663 0
Centre of the Heart and Mind,
Australian Catholic University,
Level 5, 215 Spring Street,
Melbourne, VIC 3000
Country 60663 0
Australia
Phone 60663 0
61392313779
Fax 60663 0
Email 60663 0
[email protected]
Contact person for scientific queries
Name 60664 0
Chantal Ski
Address 60664 0
Centre of the Heart and Mind,
Australian Catholic University,
Level 5, 215 Spring Street,
Melbourne, VIC 3000
Country 60664 0
Australia
Phone 60664 0
+61399533681
Fax 60664 0
Email 60664 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: Study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1559-y
N.B. These documents automatically identified may not have been verified by the study sponsor.