Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000058572
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
22/01/2015
Date last updated
9/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving care outcomes through navigation in stroke
Scientific title
Stroke patients and their families receiving stroke navigation services compared with usual care to evaluate the effect on well-being, quality of life, carer strain and functional indices.
Secondary ID [1] 283623 0
Nil
Universal Trial Number (UTN)
U1111-1147-8945
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290552 0
Stroke patients and their extended families 290553 0
Condition category
Condition code
Stroke 290950 290950 0 0
Ischaemic
Stroke 290951 290951 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Navigation services provided by a stroke navigator in the first 6 months post stroke across the care continuum (in-patient and community based). Rather than applying a ‘one size fits all’ approach, the stroke navigator (trained in care navigation) will work alongside the extended family to assess, identify and address individual/ family needs with the aim of improving the wellbeing of both family and patient. An extensive scoping literature review (McKechnie et al., submitted for publication) has not identified any data on what the expected workload of the stroke navigator might be. Following discussions with our stakeholders and other anecdotal evidence we have estimated an average of three hours per family per week over the six month intervention phase of the study. With individual family needs and the nature of the post-stroke trajectory, it is anticipated that there will be times when the stroke navigator may work more than three hours a week with a family; at other times less. We anticipate there will be a degree of flexibility in the type of interaction (e.g. face-to-face, phone, email) and the time required to meet the needs of specific families.
Intervention code [1] 288317 0
Treatment: Other
Comparator / control treatment
Standard treatment/usual care will be provided to control group patients and families in the first 6 months post stroke across the care continuum. This will include access to current models of care delivery for in-patient integrated care planning (key worker) for information, education and support as well as usual access to community based services.
Control group
Active

Outcomes
Primary outcome [1] 290932 0
Patients: Quality of Life (SF36)
Timepoint [1] 290932 0
At baseline and 3 and 6 months after commencement
Primary outcome [2] 294111 0
Family/whanau members: Assessment of carer strain - Carer Strain Index (CSI)
Timepoint [2] 294111 0
At baseline and 3 and 6 months after commencement
Secondary outcome [1] 305621 0
Patients: Activities of daily living - Functional Independence Measure (FIM)
Timepoint [1] 305621 0
At baseline and 3 and 6 months after commencement
Secondary outcome [2] 312521 0
Family/whanau members: Quality of Life (SF36)
Timepoint [2] 312521 0
At baseline and 3 and 6 months after commencement

Eligibility
Key inclusion criteria
People (aged over 18 years) who experience a stroke and are admitted to one of two local hospitals AND have at least two members of their extended family (aged over 18 years) willing to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to communicate in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients admitted to Hospital 1 and Hospital 2 following a stroke will be identified and they and their whanau will be invited to participate. Hospital 2 will act as the control site; the stroke navigator service will be implemented at Hospital 1. Potential participants will be identified from admission data and recruited by clinical staff and, as appropriate, the He Kamaka Waiora team at the local District Health Board. Consistent with the recommendations of our Maori stakeholder group, 50% of our sample will be Maori who will work with a Maori Navigator if that is their preference.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 12 stroke survivors and their whanau (6 from Hospital 1 and 6 from Hospital 2) will be recruited. At least two members from each participating whanau will be recruited giving a minimum of 36 participants. This represents 10% of the proposed sample for a larger intervention study (SFWP Phase 3c), and previous research (O'Connor et al., 2014) confirms this is sufficient to achieve valid findings using our proposed processes and methods.

Thirty six participants will be the minimum number recruited (the stroke survivor plus 2 family/whanau members from each of 12 SS/whanau groups). We will not limit participation to only 2 whanau members, so it is possible that we may recruit 3 or 4 members of some whanua. Hence an estimate of 50 participants.

For the full study (SFWP Phase 3c - for which separate trial registration will be made), sample size calculation (BioCalc iApp) - based on MCSI and using recent data from Harwood et al. (2012b), we will need a minimum of 61 participants in the intervention arm and 183 in the other arms (including the retrospective study) (244 in total) (beta of 0.05 and 80% power). This figure represents the number of patients (stroke survivors) required. There will also be a minimum of two whanau recruited for every patient who consents to participate. A condition of entry into the study will be participation of whanau as well as the patient. Recruitment will continue past the required 61 patient participants in each arm to oversample for the likely deaths that will occur during the 12 months of the study as well as for drop-outs.

Scores recorded for assessment instruments will be compared over time within groups and also between groups at each time point and over time. Data analysis will include test / re-test reliability, ANOVA, Chi-Square and some aspects of multivariate analysis - possibly factor analysis. Baseline comparability of the intervention and control group will be assessed via descriptive analyses, in terms of age, sex, ethnicity, type of stroke, and stroke trajectory.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2015
Actual
4/06/2015
Date of last participant enrolment
Anticipated
Actual
2/11/2015
Date of last data collection
Anticipated
Actual
30/04/2016
Sample size
Target
50
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 5646 0
New Zealand
State/province [1] 5646 0
Auckland

Funding & Sponsors
Funding source category [1] 288305 0
University
Name [1] 288305 0
Unitec Institute of Technology Strategic Research Fund
Country [1] 288305 0
New Zealand
Primary sponsor type
University
Name
Unitec Institute of Technology
Address
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 287023 0
None
Name [1] 287023 0
Address [1] 287023 0
Country [1] 287023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290199 0
Health and Disability Ethics committees
Ethics committee address [1] 290199 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON
Ethics committee country [1] 290199 0
New Zealand
Date submitted for ethics approval [1] 290199 0
29/01/2015
Approval date [1] 290199 0
12/03/2015
Ethics approval number [1] 290199 0
15/NTA/11

Summary
Brief summary
Care-navigators are used to help patients with the complex care associated with cancer, but have not been studied widely in the setting of stroke. This study will evaluate a professional stroke navigator service to assist people who experience a stroke, and their family/whanau, to negotiate the healthcare system. We hope this will increase interaction, and satisfaction, with health service providers, helping the patient and family/whanau to manage the on-going challenges that stroke imposes. The navigator will work with the patient and whanau before they leave hospital and for six months afterwards. The aim is to improve the emotional and physical wellbeing and safety of the patient and family/whanau through increased informative and beneficial interactions with health professionals and the wider healthcare system. This will be tested in a clinical trial, where the stroke navigator group outcomes will be compared to a group of patients receiving usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44442 0
A/Prof Dianne Roy
Address 44442 0
Department of Nursing
Faculty of Social and Health Sciences
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 44442 0
New Zealand
Phone 44442 0
+64 21 581096
Fax 44442 0
Email 44442 0
[email protected]
Contact person for public queries
Name 44443 0
A/Prof Dianne Roy
Address 44443 0
Department of Nursing
Faculty of Social and Health Sciences
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 44443 0
New Zealand
Phone 44443 0
+64 21 581096
Fax 44443 0
Email 44443 0
[email protected]
Contact person for scientific queries
Name 44444 0
A/Prof Dianne Roy
Address 44444 0
Department of Nursing
Faculty of Social and Health Sciences
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 44444 0
New Zealand
Phone 44444 0
+64 21 581096
Fax 44444 0
Email 44444 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

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