Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000105943
Ethics application status
Approved
Date submitted
25/11/2019
Date registered
5/02/2020
Date last updated
20/02/2024
Date data sharing statement initially provided
5/02/2020
Date results information initially provided
20/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Support After Stroke with group-based classeS: The SASS study
Scientific title
Support After Stroke with group-based classeS: The SASS study: Phase II randomised controlled trial assessing the underlying changes to the brain
Secondary ID [1] 298991 0
Nil known
Universal Trial Number (UTN)
U1111-1241-0833
Trial acronym
SASS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stroke 313997 0
Condition category
Condition code
Stroke 312386 312386 0 0
Ischaemic
Stroke 312387 312387 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Arm: Weekly 60 minute group movement-based yoga and mindfulness classes for 12 weeks (~4-5 participants per class). The program will teach mindfulness meditation through breathing and a set of postures that are appropriate for a beginner. The classes will allow for progression, but participants are always able to adjust to the level that best suits them on the day.
Intervention will be delivered by trained and experienced yoga teachers (one lead and one assistant per class).
Adherence will be monitored using attendance logs.

20 minutes home practice of mindfulness meditation daily (provided on CD/audio link). Adherence will be monitored using participant diary.
Intervention code [1] 315260 0
Prevention
Comparator / control treatment
Attention Control Arm: Weekly facilitated social group classes (~4-5 per class; 60 minutes) on lifestyle strategies for 12 weeks. Practical education on generic topics such as using technology, managing finances, nutritional cooking, tips for driving, getting back to work, travel experiences, internet for beginners, pastimes and hobbies for people with a disability or cognitive improvement., Each 60 minutes class will include 15-20 mins of lectures, followed by discussion time.
Participants will not be asked to do home practice.
Control group
Active

Outcomes
Primary outcome [1] 321024 0
Composite primary: Changes in brain structure (i.e., cortical thickness, resting-state connectivity, structural connectivity and cerebral blood flow) assessed using Magnetic Resonance Imaging (MRI) brain scans.
Timepoint [1] 321024 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [1] 373717 0
Stress assessed by cortisol levels in hair and perceived stress scale as a composite outcome.
Timepoint [1] 373717 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [2] 375267 0
Blood pressure assessed by OMRON blood pressure monitor
Timepoint [2] 375267 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [3] 375268 0
Blood glucose (HbA1c) assessed by A1CNow+ Portable HbA1c Test Kit
Timepoint [3] 375268 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [4] 375269 0
Blood cholesterol assessed by CardioChek+ Portable Lipids Test Kit
Timepoint [4] 375269 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [5] 375270 0
Health status and Quality of life assessed using the SIS and EQ-5D-3L questionnaires.
Timepoint [5] 375270 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [6] 375271 0
Mood assessed using Hospital Anxiety and Depression Scale and the Depression Anxiety Stress Scale
Timepoint [6] 375271 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [7] 375272 0
Fatigue assessed using the Fatigue Assessment Scale
Timepoint [7] 375272 0
Baseline, and at 12 weeks after intervention commencement (~13 weeks)
Secondary outcome [8] 379088 0
Satisfaction with program will be assessed using study specific questionnaires for the intervention and control group with a combination of questions seeking responses on a 5 point Likert scale and open ended questions
Timepoint [8] 379088 0
12 weeks after intervention commencement (~13 weeks)
Secondary outcome [9] 379544 0
General feedback will be assessed using qualitative interviews. These interviews will be group face-to-face sessions, and include open-ended questions. The interviews will be audio-recorded, and will run for around 60 minutes.
Timepoint [9] 379544 0
12 weeks after intervention commencement (~13 weeks)

Eligibility
Key inclusion criteria
• Aged 18 years or more
• Confirmed diagnosis of stroke whereby the last stroke event is between 3 and 12 months
• Participants living in the community (not nursing home or aged care residential facilities) within 30 kms of BrainPark (770 Blackburn Rd, Clayton VIC 3168, Australia)
• Have access to email and/or SMS (to access home practice guide, and receive class reminders)
• Self-identify as users of electronic technology such as CD player (to access home practice guide)
• Have a baseline Modified Rankin Score of 0 (i.e. no disability) to 4 (i.e. may require some assistance but not constant care);
• Able to give informed written consent and can understand two-step verbal commands; already enrolled in other clinical trial, as long as there will be no issues with contamination to either trial, and that there is assurance that responder burden is minimal
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants will be excluded if:
• Undertaking a mindfulness program (meditation, Tai Chi, yoga) or have done these regularly (e.g. monthly in frequency) in the 12 months prior to stroke
• Cannot verbally communicate in English. Due to constraints of our budget, translation of yoga intervention delivery by experts into other languages will not be possible
• Have significant language or communication impairments that will restrict the ability to participate
• Poor prognosis (unlikely to survive to 12 weeks following randomisation)
• Presence of contraindications to MRI (e.g. metallic or electronic implants not known to be safe)
• Suffer from claustrophobia (i.e. inability to be in MRI scans where space is constraint)

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 phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence using a 1:1 ratio with permutated blocks of various sizes will be
done through the REDCap database system
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
Composite outcome (changes in cortical thickness and resting state connectivity). Imaging Magnetic resonance imaging (MRI) will be obtained for the assessment of cortical thickness (T1- & T2-weighted MRI), functional (resting-state T2* blood oxygenation level dependent functional MRI [BOLD-fMRI]), structural connectivity (diffusion weighted imaging [DWI]) and cerebral blood flow (arterial spin labelling [ASL]), and used to describe changes in brain structure, function and perfusion from baseline to 3-months, e.g. within the default mode network.
Secondary outcomes: Descriptive statistics will be used to describe the trial population at baseline. Between-group analyses (parametric or non-parametric based on data characteristics) will be conducted to obtain variance and treatment effect sizes for all primary and secondary outcome measures. Within group changes will be examined using McNemar’s test and between group differences will be examined using parametric or non-parametric
methods appropriate to the distribution of the data. Where feasible, multivariable statistical models will also be used to adjust for baseline differences between the intervention and control groups for baseline variables with a p-value of <0.2.
Treatment of missing data will be based on the satisfiability of ‘missingness at random’ assumptions.
Feasibility data will be analysed descriptively including participation in classes and dropouts, missing data on surveys, poor quality or uninterpretable data from biological or other tests.
Intervention fidelity data including class participation logs, home based practice diaries and the project issues register will also be summarised. Focus group and open text responses from the satisfaction surveys will be analysed using inductive thematic analysis methods with coding checked by two researchers.
The quantitative and qualitative data will be used to fine-tune the intervention and design of a larger scale Phase III effectiveness trial. As part of this process, the findings from each aspect of the project will be triangulated as part of the interpretative process.
Triangulation is the combination of at least two or more theoretical perspectives, methodological approaches, data sources, investigators, or data analysis methods. This work will provide evidence to ensure the study can be reported in detail and will inform the design a future fully powered and well-designed effectiveness trial for this type of complex intervention.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
We were unable to conduct group-based, in-person interventions during the COVID-19 pandemic. Recruitment during this period was difficult as well. We undertook the study in Melbourne, Victoria (Australia) that had the greatest lock down periods compared with other locations and countries.
Date of first participant enrolment
Anticipated
1/03/2020
Actual
1/05/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
28/06/2023
Date of last data collection
Anticipated
30/12/2023
Actual
1/12/2023
Sample size
Target
60
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303530 0
University
Name [1] 303530 0
Monash University
Country [1] 303530 0
Australia
Funding source category [2] 303930 0
Charities/Societies/Foundations
Name [2] 303930 0
Cooper Foundation via Swan Research Institute
Country [2] 303930 0
Australia
Funding source category [3] 303931 0
University
Name [3] 303931 0
Monash University
Country [3] 303931 0
Australia
Funding source category [4] 303932 0
Other Collaborative groups
Name [4] 303932 0
Centre of Research Excellence in Stroke Rehabilitation and Brain Recovery
Country [4] 303932 0
Australia
Funding source category [5] 304368 0
Other Collaborative groups
Name [5] 304368 0
Hunter Medical Research Institute
Country [5] 304368 0
Australia
Funding source category [6] 312665 0
University
Name [6] 312665 0
MBI User scheme access grant, Monash University
Country [6] 312665 0
Australia
Funding source category [7] 315876 0
Other Collaborative groups
Name [7] 315876 0
STOPstroke Synergy grant
Country [7] 315876 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd,
Clayton
VIC 3800
Country
Australia
Secondary sponsor category [1] 303595 0
None
Name [1] 303595 0
Address [1] 303595 0
Country [1] 303595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304057 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 304057 0
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 304057 0
Australia
Date submitted for ethics approval [1] 304057 0
04/09/2019
Approval date [1] 304057 0
31/10/2019
Ethics approval number [1] 304057 0

Summary
Brief summary
Stroke is the leading cause of disability from physical, social and mental health impacts (e.g. 1 in 3 survivors have depression after stroke) and affects over 420,000 Australians, with 50,000 new events each year. Community-based options for preventing comorbidity and supporting recovery after stroke are limited. We are proposing to test whether a mindfulness-based intervention (MBI), specifically designed for survivors of stroke that uses movement and meditation to focus on body awareness and breathing is acceptable and feasible. Prior studies of MBIs in older adults, cardiac and cancer populations provide evidence of reduced stress, fatigue, mood disorders such as anxiety and depression, lower blood pressure and improved quality of life. Our aim is to perform a feasibility trial among people within 3-12 months of a stroke who are living at home. Participants will either receive the SASS intervention (12 week MBI program includes weekly group class and home practice) or attention control intervention (12 week social group). This research project will provide important pilot data for work that will have the potential to impact on a large number of survivors of stroke living in the community who need support with managing the consequences of their stroke. If successful this pilot data will provide the rationale for future related work which has the potential to save lives and improve the quality of life of thousands of survivors of stroke.
Trial website
Trial related presentations / publications
Public notes
Intervention fidelity will be monitored throughout the trial by an independent member of the research team who will monitor group
classes and procedures for baseline and outcome assessments.
Focus groups will be conducted with up to 10 participants in either intervention group and a separate interview/ semi-structured survey will occur with the instructors involved in the group classes. The selection will include a range of ages and balance of males and females, and those who attended all or some of the allocated group classes. The qualitative interviews will be used to seek feedback on participants’ satisfaction with the program of research and suggestions for areas of improvement. Satisfaction levels will be sought from instructors regarding their experience with delivering the classes in the intervention or control arm. Satisfaction levels will also be assessed from the perspective of yoga instructors regarding the delivery of the intervention and staff collecting outcome measures.Qualitative interviews will be a group face-to-face sessions, and include open-ended questions. The interviews will be audio-recorded, and will run for around 60 minutes.

Contacts
Principal investigator
Name 95674 0
Prof Dominique Cadilhac
Address 95674 0
Stroke and Ageing Research Group
Level 2 - Monash University
Victorian Heart Hospital
631 Blackburn Road
Clayton VIC 3168
Country 95674 0
Australia
Phone 95674 0
+61 3 7511 1865
Fax 95674 0
Email 95674 0
[email protected]
Contact person for public queries
Name 95675 0
Dr Tharshanah Thayabaranathan
Address 95675 0
Stroke and Ageing Research Group
Level 2 - Monash University
Victorian Heart Hospital
631 Blackburn Road
Clayton VIC 3168
Country 95675 0
Australia
Phone 95675 0
+61 3 7511 1968
Fax 95675 0
Email 95675 0
[email protected]
Contact person for scientific queries
Name 95676 0
Prof Dominique Cadilhac
Address 95676 0
Stroke and Ageing Research Group
Level 2 - Monash University
Victorian Heart Hospital
631 Blackburn Road
Clayton VIC 3168
Country 95676 0
Australia
Phone 95676 0
+61 3 7511 1865
Fax 95676 0
Email 95676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
On completion of publications by the investigators and the SASS collaborators, anonymised data will be available for secondary research purposes such as pooling data for meta-analyses of similar studies, or complimentary research questions.
When will data be available (start and end dates)?
Anticipated from 2024, no end date determined
Available to whom?
Academics and students
Available for what types of analyses?
Research questions that do not replicate our primary and secondary outcome analyses
How or where can data be obtained?
Direct contact via email with the Coordinating Principal Investigator, Professor Dominique Cadilhac ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5099Study protocol  [email protected]
5100Informed consent form  [email protected]
5101Clinical study report  [email protected]
5102Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIResearch Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry2024https://doi.org/10.1016/j.jphys.2024.02.015
N.B. These documents automatically identified may not have been verified by the study sponsor.