Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000133134
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
30/01/2019
Date last updated
11/03/2022
Date data sharing statement initially provided
30/01/2019
Date results information initially provided
11/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Meeting unmet needs following minor stroke
Scientific title
The SUN (Stroke Unmet Needs) study
Secondary ID [1] 297118 0
None
Universal Trial Number (UTN)
U1111-1226-9183
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Minor stroke 311139 0
Condition category
Condition code
Stroke 309767 309767 0 0
Ischaemic
Stroke 309768 309768 0 0
Haemorrhagic
Public Health 309904 309904 0 0
Health service research
Physical Medicine / Rehabilitation 309905 309905 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: New service pathway: A multi-component pathway comprising:
- Self-management kit: Immediately prior to hospital discharge patients will receive a written information pack from the research assistant (with verbal support at the time). Self-management programs are effective approaches in stroke management and are recommended in the new Stroke Foundation Clinical Guidelines for Acute Stroke Management. Additionally, there is a plethora of research suggesting that written information about stroke on discharge from hospital can be beneficial. The self-management kit will include written information about common difficulties specific to minor stroke, the need to see a General Prarctitioner (GP) after discharge from hospital for ongoing support, need for medications, referral to allied health services, and issues for the patient to discuss with their GP (via checklist). Participants will also receive the My Stroke Journey from the Stroke Foundation, which is a booklet available to all stroke patients that provides general stroke information.
- Customised screening checklist: To encourage patients to be self-management experts in collaboration with their GP, patients will be provided with a checklist (as part of the self-management kit) to share with their GP. The checklist will include questions about services accessed and residual difficulties/changes post-stroke. There will be space in the checklist for the patient to add extra questions relevant to their individual situation. Use of the checklist to guide the consultation is optional.
- Minor stroke community group: Patients will also be informed about a once-weekly minor stroke community group. The group will occur once a week for 1.5 hours at four different rotating locations. Group sessions have been identified as a critical ingredient of successful self-management programs in chronic disease. The group sessions will include brief information about common problems following minor stroke, need for medications, referral to allied health services if required, issues to discuss with GPs, and will have a guest speaker from a different health discipline each time (the role of the speakers will be to provide expert information about comments difficulties experienced within the topic by people with minor stroke and strategies that attendees can implement in their daily life. The speakers will be qualified health professionals e.g., dietician speaking about healthy eating after stroke, occupational therapist discussing return to driving). Information will be bite sized and patients will receive a short written summary to take home. The final part of the session will be social, providing patients with a chance to discuss issues, build relationships and receive peer support. This is a critical evidence-based component of effective chronic disease care, with our pilot finding that the most common impairments experienced following minor stroke were reduced social participation and mental health. These group sessions will also welcome carers. The group sessions will run in a series of approximately 8 sessions. Participants will be able to choose whether to attend specific or all sessions. Treatment fidelity will occur by audiotaping the sessions and then fidelity checking a random sample of 20% of sessions.
Intervention code [1] 313382 0
Treatment: Other
Intervention code [2] 313383 0
Rehabilitation
Intervention code [3] 313384 0
Lifestyle
Comparator / control treatment
Control condition: Usual care: The usual care group will receive the usual care provided to minor stroke patients following discharge from PAH. This process often involves sending an electronic summary to the patient’s GP from the hospital records if available and sometimes an outpatient follow-up appointment at the hospital. Requirement for outpatient follow-up is determined at the time of discharge depending on the patient’s medical issues. All patients should also receive the My Stroke Journey pack as education and discharge planning, however, this is not specific to minor stroke. Patients may be referred to private allied health providers or community services, however, this does not occur for every patient. Patients may receive a follow up phone call from the Stroke Foundation, however, in our pilot this was reported by only one patient.
Control group
Active

Outcomes
Primary outcome [1] 318727 0
Survey of Unmet Needs (SUNSU): Self-rating scale determining needs across impairment, activities of daily living, occupational activities, psychological needs, and community access.
Timepoint [1] 318727 0
Within 24 hours before hospital discharge, and 1 (primary endpoint) and 3 months later
Secondary outcome [1] 365828 0
Mayo-Portland Adaptability Inventory-4 (MPAI-4): Rating scale completed by the individual, clinician or informant about ability, adjustment, and participation. This will be analysed as a single outcome regardless of whether the individual, clinician or informant completes the rating scale.
Timepoint [1] 365828 0
Within 24 hours of hospital discharge, and 1 and 3 months later
Secondary outcome [2] 365829 0
Exeter Identity Transition Scales (EXITS): To record social group membership before and after stroke.
Timepoint [2] 365829 0
Within 24 hours of hospital discharge, and 1 and 3 months later
Secondary outcome [3] 365830 0
Return to previous occupation (yes/no)
Timepoint [3] 365830 0
Within 24 hours of hospital discharge, and 1 and 3 months later
Secondary outcome [4] 365831 0
RAND 36-Item Health Survey 1.0 (SF-36): To assess subjective health and quality of life across eight domains: physical functioning, pain, role limitations, emotional well-being, social functioning, energy, and perceptions about general health, and perceived change in health.
Timepoint [4] 365831 0
Within 24 hours of hospital discharge, and 1 and 3 months later
Secondary outcome [5] 365832 0
Stroke Specific Quality of Life Scale (SSQOL): Measure of health-related quality of life specific to stroke that includes communication function.
Timepoint [5] 365832 0
Within 24 hours of hospital discharge, and 1 (primary endpoint) and 3 months later
Secondary outcome [6] 365833 0
Semi-structured interview regarding patients’ perceptions of the program (including content, timing, frequency, duration, additional elements to be included, additional services accessed, and unmet needs).
Timepoint [6] 365833 0
Within 24 hours of hospital discharge, and 1 and 3 months later

Eligibility
Key inclusion criteria
Admitted to the PAH with first ever stroke with minor deficits at the time of discharge (total length of stay in hospital < 2 weeks inclusive of all episodes of care) and having scores on the National Institutes of Health Stroke Scale (NIHSS, score 0-5) and Modified Rankin Scale (mRS, score 0-1) consistent with minor or no obvious deficits. Participants will be aged > 18 years and have no other neurological conditions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of stroke, unable to complete written questionnaires in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will initially be analysed using descriptive analysis (counts, means, standard deviations where appropriate). Repeated Measures Analyses of Variance will be used to analyse within and between group differences at discharge, and 1 and 3 months on the SUNSU, MPAI, EXITS, SF-36, SSQOL, number of services used, and hospital readmissions. Return to work will be analysed using Chi square tests. Semi-structured interviews will be analysed using qualitative content analysis to identify key themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
Actual
4/11/2020
Date of last data collection
Anticipated
Actual
1/03/2021
Sample size
Target
110
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12941 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 25414 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301680 0
Government body
Name [1] 301680 0
Metro South Hospital and Health Service Research Support Scheme
Country [1] 301680 0
Australia
Primary sponsor type
Individual
Name
Emma Finch
Address
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Queensland, 4102
Country
Australia
Secondary sponsor category [1] 301399 0
None
Name [1] 301399 0
Address [1] 301399 0
Country [1] 301399 0
Other collaborator category [1] 280490 0
Individual
Name [1] 280490 0
Professor Michele Foster
Address [1] 280490 0
The Hopkins Centre, Division of Rehabilitation MSH and Griffith University
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country [1] 280490 0
Australia
Other collaborator category [2] 280491 0
Individual
Name [2] 280491 0
Dr Darshan Shah
Address [2] 280491 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country [2] 280491 0
Australia
Other collaborator category [3] 280492 0
Individual
Name [3] 280492 0
Mrs Katherine Jaques
Address [3] 280492 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country [3] 280492 0
Australia
Other collaborator category [4] 280493 0
Individual
Name [4] 280493 0
Dr Phlip Aitken
Address [4] 280493 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country [4] 280493 0
Australia
Other collaborator category [5] 280494 0
Individual
Name [5] 280494 0
Professor Jennifer Fleming
Address [5] 280494 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Campus 4072
Country [5] 280494 0
Australia
Other collaborator category [6] 280495 0
Individual
Name [6] 280495 0
Dr Tegan Cruwys
Address [6] 280495 0
Research School of Psychology
Australian National University
39 Science Road
The Australian National University
ACT 0200
Country [6] 280495 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302400 0
Metro South HREC
Ethics committee address [1] 302400 0
Princess Alexandra Hospital
199 Ipswich Road
Woollongabba QLD 4102
Ethics committee country [1] 302400 0
Australia
Date submitted for ethics approval [1] 302400 0
16/01/2019
Approval date [1] 302400 0
20/03/2019
Ethics approval number [1] 302400 0

Summary
Brief summary
Minor stroke is a stroke that leads to minimal motor deficits and/or no obvious sensory abnormality. Milder post-stroke impairments are often hidden in the supported hospital environment, instead manifesting only when the patients have returned home and attempt to resume their everyday activities. Despite the high incidence of minor stroke in Australia and the personal and societal impact of ongoing limitations in functioning, there is no established integrated care for managing minor stroke patients beyond hospital discharge. The primary aim of this project is to assess whether a new multi-component service pathway for minor stroke patients will reduce unmet need compared with usual care and 1 and 3 month’s post-hospital discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90106 0
Dr Emma Finch
Address 90106 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4012
Country 90106 0
Australia
Phone 90106 0
+61 7 38963133
Fax 90106 0
Email 90106 0
e.finch@uq.edu.au
Contact person for public queries
Name 90107 0
Dr Emma Finch
Address 90107 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4012
Country 90107 0
Australia
Phone 90107 0
+61 7 38963133
Fax 90107 0
Email 90107 0
e.finch@uq.edu.au
Contact person for scientific queries
Name 90108 0
Dr Emma Finch
Address 90108 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4012
Country 90108 0
Australia
Phone 90108 0
+61 7 38963133
Fax 90108 0
Email 90108 0
e.finch@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are still determining whether this is possible


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.