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Trial registered on ANZCTR


Registration number
ACTRN12613000776707
Ethics application status
Approved
Date submitted
7/07/2013
Date registered
11/07/2013
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Date results information initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Very Early Rehabilitation in Speech in patients with aphasia following stroke.
Scientific title
A three armed, prospective multicentre randomised controlled speech therapy trial comparing usual care, usual care plus and Very Early Rehabilitation in Speech (VERSE) with blinded outcome assessment of the Aphasia Quotient score in patients with aphasia following acute stroke.
Secondary ID [1] 282791 0
Nil known
Universal Trial Number (UTN)
U1111 - 1145 - 4130
Trial acronym
VERSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 289561 0
Stroke 289578 0
Condition category
Condition code
Stroke 289888 289888 0 0
Ischaemic
Stroke 289911 289911 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 289912 289912 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm Two Usual care Plus - Increased intensity of speech therapy sessions (uncontrolled) The therapy provided is at the discretion of the speech therapist based on usual care speech therapy provided in the stroke unit. It involves a combination of non standardised aphasia therapy, counselling and patient/family education however the intensity or the number of treamtent sessions will be specified and equivalent to 20 sessions of 45 - 60 minutes. There will be a minimum of 3 and a maximum of 5 sessions per week. Intevention must be completed within a maximum 25 working days after baseline assessment.
Arm 3 VERSE intervention - Increased intensity of speech therapy sessions (prescribed) The number of sessions will be equal to arm 2 (20 sessions of 45 - 60 minutes of 1:1 speech therapy, but the intervention will be standardised and prescribed by an expert advisory committee for the therapist to follow. The intervention will be specifically tailored to meet specific set goals based on patients needs and include predominantly direct 1:1 therapy.
All sessions in all arms of treatment will be recorded. Documentation will include the date, duration and content of each session. A random sample of sessions will be recorded and submitted to the study monitor to ensure adherence to the protocol.
Intervention code [1] 287474 0
Rehabilitation
Comparator / control treatment
Arm 1- Usual Care. The therapy provided is at the discretion of the speech therapist based on usual care speech therapy provided in the stroke unit. It involves a combination of non standardised aphasia therapy, counselling and patient/family education. Audited results indicate that usual care consists of 14 minutes per week but therapists report 1- 3 sessions of 30 minutes a week. In this trial we anticipate that usual care speech therapy will be less than 6 hours in total during the trial intervention period. (up to 25 days)
Control group
Active

Outcomes
Primary outcome [1] 289950 0
Aphasia Quotient (AQ)score
Timepoint [1] 289950 0
12 weeks post stroke
Secondary outcome [1] 303639 0
Aphasia Quotient (AQ) score
Timepoint [1] 303639 0
26 weeks post stroke
Secondary outcome [2] 303640 0
Discourse Analysis (Correct Information Units)
Timepoint [2] 303640 0
12 and 26 weeks post stroke
Secondary outcome [3] 303641 0
Anxiety Depression Rating Score (ADRS)
Timepoint [3] 303641 0
12 and 26 weeks post stroke
Secondary outcome [4] 303642 0
Stroke and Aphasia Quality of Life (SAQoL)
Timepoint [4] 303642 0
12 and 26 weeks post stroke
Secondary outcome [5] 303643 0
Resource Utilisation Questionnaire
Timepoint [5] 303643 0
26 weeks post stroke

Eligibility
Key inclusion criteria
Acute stroke with resultant acute aphasia of any type and score < 93.7 of the Aphasia Quotient (no TIA, SAH or SDH)
Medical stability at recruitment
Ability to maintain a wakeful alert state for 30 consecutive minutes within 14 days of stroke onset
Normal or corrected hearing and vision.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing clinical diagnosis of dementia
Diagnosis or treatment of major depression at the time of enrolment
Concurrent participation in another interventional trial


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)
Participants will be assigned to group via a web based centralized automated allocation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated blocked and stratified randomisation procedure will allocate participants to one of three treatment arms. Participants will be stratified based on aphasia severity, determined by the Aphasia Quotient and the acute care hospital site.
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
Analysis Method:
The primary aim of this trial is to test the effect of intensity of therapy in early stroke recovery. This is achieved through the primary effectiveness hypothesis which will be analysed using a linear mixed effects regression model with % Maximal Potential Recovery (%MPR) as the outcome measure. The UC-Plus and VERSE groups will be combined into a single high intensity group. This combined intervention group will be compared to the UC group on the primary outcome measure (%MPR16 at 12 weeks). The model will adjust for differences in baseline aphasia severity and baseline stroke severity by including the baseline WAB-R(AQ) score and the baseline NIHSS4 score as covariates in the model. The effect of hospital site will be controlled for by including hospital site as a random effect. The treatment effect will be reported as difference in %MPR with the corresponding 95% confidence interval.
Since publication of the trial protocol five new sites have been added to address low participant recruitment. As a result, the Executive Committee decided there was a need to include hospital site as a random effect. This required the adaptation of our original statistical plan from using General Estimating Equations model (GEE) to a Linear Mixed Effect Regression models.

Subgroup Analyses:
The linear mixed effects regression model will be modified to analyse the difference in the primary effectiveness outcome (%MPR at 12 weeks) between
1) the VERSE group and UC group AND
2) the UC- Plus group and the UC group
As with the primary analysis, the model will adjust for differences in baseline aphasia severity and baseline stroke by including the baseline WAB-R(AQ) score and the baseline NIHSS score as covariates in the model. The effect of hospital site will be controlled for by including recruiting site as a random effect. The treatment effect for each subgroup analysis will be reported as difference in %MPR16 with the corresponding 95% confidence interval.
No corrections for multiple testing in subgroup analyses will be undertaken for these planned analyses. The unadjusted p-values will be reported together with the number of subgroup analyses undertaken.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 1212 0
Joondalup Health Campus - Joondalup
Recruitment hospital [2] 1213 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 1214 0
Cairns Base Hospital - Cairns
Recruitment hospital [4] 1217 0
St George Hospital - Kogarah
Recruitment hospital [5] 1219 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 1220 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [7] 3397 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [8] 5125 0
Gold Coast Hospital - Southport
Recruitment hospital [9] 5126 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 5127 0
The Alfred - Prahran
Recruitment hospital [11] 5128 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [12] 5129 0
Concord Repatriation Hospital - Concord
Recruitment hospital [13] 5130 0
Prince of Wales Hospital - Randwick
Recruitment hospital [14] 5131 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [15] 13530 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 7127 0
6027 - Joondalup
Recruitment postcode(s) [2] 7128 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [3] 7129 0
4870 - Cairns
Recruitment postcode(s) [4] 7132 0
2217 - Kogarah
Recruitment postcode(s) [5] 7134 0
2050 - Camperdown
Recruitment postcode(s) [6] 7135 0
6160 - Fremantle
Recruitment postcode(s) [7] 9180 0
2640 - Albury
Recruitment postcode(s) [8] 12590 0
3065 - Fitzroy
Recruitment postcode(s) [9] 12591 0
3181 - Prahran
Recruitment postcode(s) [10] 12592 0
6009 - Nedlands
Recruitment postcode(s) [11] 12593 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [12] 12594 0
2031 - Randwick
Recruitment postcode(s) [13] 12595 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [14] 12596 0
4215 - Southport
Recruitment postcode(s) [15] 26150 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 8221 0
New Zealand
State/province [1] 8221 0
Tauranga and Christchurch

Funding & Sponsors
Funding source category [1] 287567 0
Government body
Name [1] 287567 0
National Health and Medical Research Council
Address [1] 287567 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 287567 0
Australia
Funding source category [2] 302377 0
Charities/Societies/Foundations
Name [2] 302377 0
The Tavistock Trust for Aphasia
Address [2] 302377 0
Bedford House
15 George Street
Woburn
Bedfordshire MK179PX
Country [2] 302377 0
United Kingdom
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 286319 0
None
Name [1] 286319 0
Address [1] 286319 0
Country [1] 286319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289541 0
Melbourne Health
Ethics committee address [1] 289541 0
Grattan St Parkville Victoria 3050
Ethics committee country [1] 289541 0
Australia
Date submitted for ethics approval [1] 289541 0
29/07/2013
Approval date [1] 289541 0
22/05/2014
Ethics approval number [1] 289541 0

Summary
Brief summary
Trial Objectives
To demonstrate that a standardised and prescribed intensive speech therapy regimen for aphasia is more effective and cost saving than non-standardised usual care training methods in the very early post-stroke recovery period.

Primary Hypothesis:
Very early aphasia therapy will result in greater improvement in communication at 12 weeks post-stroke, as measured by the Western Aphasia Battery-Revised; Aphasia Quotient (WAB-R (AQ)).
Secondary Hypotheses:
1. VERSE aphasia therapy will result in a greater improvement in communication than UC-Plus aphasia therapy at 12 and 26 weeks post stroke, as measured by the WAB-R (AQ).
2. VERSE aphasia therapy and UC-Plus will each result in greater improvements in communication than U C alone, as measured by the WAB-R(AQ), at 12 weeks and 26 weeks post stroke.
3. VERSE aphasia therapy will result in greater improvements in connected speech than UC-Plus, as measured by Discourse Analysis, at 12 weeks and 26 weeks post stroke.
4. VERSE aphasia therapy and UC-Plus will each result in greater improvements in connected speech than UC alone, as measured by Discourse Analysis, at 12 weeks and 26 weeks post stroke.
5. Very early aphasia therapy (UC-Plus and VERSE) will result in better quality of life at 12 and 26 weeks post stroke than UC control.
6. Very early aphasia therapy (UC-Plus and VERSE) will be more cost-effective than UC at 12 and 26 weeks post stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41262 0
A/Prof Erin Godecke
Address 41262 0
School of Psychology and Social Sciences
Edith Cowan University
270 Joondalup Dve
JOONDALUP WA 6027
Country 41262 0
Australia
Phone 41262 0
+61 8 6304 5901
Fax 41262 0
Email 41262 0
e.godecke@ecu.edu.au
Contact person for public queries
Name 41263 0
A/Prof Erin Godecke
Address 41263 0
School of Psychology and Social Sciences
Edith Cowan University
270 Joondalup Dve
JOONDALUP WA 6027
Country 41263 0
Australia
Phone 41263 0
+61 8 6304 5901
Fax 41263 0
Email 41263 0
e.godecke@ecu.edu.au
Contact person for scientific queries
Name 41264 0
A/Prof Erin Godecke
Address 41264 0
School of Psychology and Social Sciences
Edith Cowan University
270 Joondalup Dve
JOONDALUP WA 6027
Country 41264 0
Australia
Phone 41264 0
+61 8 6304 5901
Fax 41264 0
Email 41264 0
e.godecke@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual de identified participant data underlying published results.
When will data be available (start and end dates)?
Following publication of results - no end date
Available to whom?
Researchers with a methodologically sound proposal, case by case basis at the discretion of the Principal investigator.
Available for what types of analyses?
for IPD meta analyses and to achieve the aims in approved proposals.
How or where can data be obtained?
Requirement to sign a data access agreement and approval by principal investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary