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Trial registered on ANZCTR


Registration number
ACTRN12613001263785
Ethics application status
Approved
Date submitted
28/10/2013
Date registered
18/11/2013
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Date results information initially provided
4/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Novel Approach to Real-life Communication: Narrative Intervention in Aphasia
Scientific title
For people with aphasia following stroke, is a manualised narrative intervention programme aimed at improving discourse in everyday communication situations more effective than usual speech pathology intervention as measured by improved language ability across the different levels of language (i.e. words, sentences, discourse) in everyday communication activities?
Secondary ID [1] 283416 0
Nil
Universal Trial Number (UTN)
Trial acronym
NARNIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 290329 0
Traumatic brain injury 290330 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290731 290731 0 0
Speech therapy
Stroke 290883 290883 0 0
Ischaemic
Stroke 290884 290884 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study compares two groups of clients with aphasia, one receiving a novel speech pathology intervention and the other receiving usual speech pathology care. Participants in both groups will receive 20 sessions of intervention (400 treatment sessions in total). Sessions (approx. 1 hour duration) will be offered 4 x per week over a 5 week period. This is commensurate with length of stay at the local sites and realistic for community based intervention. A total of 200 therapy sessions will therefore be provided to the 10 participants in the experimental group, and 200 sessions to the control group (by the usual speech pathologist).
For the experimental group, the intervention protocol will be developed following principles set out in Whitworth (2010), using a metalinguistic approach to increase awareness of both sentence and narrative structure. Beginning with narratives using picture sequences, the therapy will focus initially on identifying the main event/s in each picture, accessing the verb and the relevant nouns for each event, followed by creating a complete argument structure around each. A framework for narrative discourse, based on story grammar, will be introduced, and sentences organized around setting the scene (the beginning), the events taking place (the middle), and concluding the story (the end). More naturalistic situations will be introduced using a mind-mapping approach where diagrams are then used to retrieve and then link ideas, events, and words in a way that leads to the organization and planning of thoughts for subsequent production.
Intervention code [1] 288141 0
Rehabilitation
Comparator / control treatment
Participants will receive intervention determined by the usual speech pathologist in the same dosage as the intervention group. Usual care will involve therapy aimed to increase comprehension and production of language at the word and sentence levels, and functional communication goals determined by the client. This encompasses a large proportion of usual care tasks. The speech pathologist will have access to the assessment data with the exception of the data from the Discourse protocol.
Control group
Active

Outcomes
Primary outcome [1] 290730 0
The primary outcome measure is the Curtin University Discourse Protocol (CUDP) to measure performance in connected speech of everyday communication tasks. Data have already been collected on 60 healthy adult speakers and will be available to the study for comparison. The protocol involves recount of events, procedural discourse, exposition (providing opinions) and story narratives which are analyzed on a range of parameters (Whitworth, 2010). These involve novel structural frameworks drawn from the child literacy and narrative literature, and linguistic features that have been found to be diagnostic across a range of language profiles, e.g. quantitative measures of overall sentence structure, coherency and cohesion.
Timepoint [1] 290730 0
Prior to intervention, immediately-post intervention and 4 weeks post-intervention.
Secondary outcome [1] 305106 0
A range of word and sentence level measures will be taken to monitor impact on other levels of language. These include:
1. Tests of Semantic processing (Pyramids and Palm Trees, Howard & Patterson, 1992 – noun semantics; Kissing and Dancing Test, Bak & Hodges, 2003 – verb semantics)
2. Selected word and sentence comprehension and production tasks (Northwestern Test of Verbs and Sentences, 2011).
Timepoint [1] 305106 0
Prior to intervention, immediately-post intervention and 4 weeks post-intervention.

Eligibility
Key inclusion criteria
Participants will be recruited who (a) are medically stable (b) present with their first episode of aphasia (c) are undergoing rehabilitation (d) have no cognitive difficulties such as dementia (d) are able to give informed consent to participate and (e) were proficient in English prior to their stroke (i.e. used English in everyday communication). There is no restriction on type of aphasia. Mild dysarthria and/or apraxia of speech may be present but should not be the primary difficulty.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of (a) severe aphasia, including severe anomia, severe apraxia or dysarthria (b) cognitive difficulties such as dementia (c) inability to give informed consent to participate and (d) do not use English in everyday communication.

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 were enrolled and consented, and then an email, giving only the subjects’ initials, was sent to the collaborator responsible for randomisation. Allocation was concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This was determined before the start of the trial using an Excel spreadsheet, using the random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Assessors are blinded to the intervention group of the participants. Protocol of novel intervention is known only to intervention therapists.
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a one-year pilot RCT to allow us to estimate effect sizes to do a proper power calculation.The primary interest is in using ANOVA with one between-subject factor (2 treatment types) and one within-subject factor (before and after treatment). An effect of treatment would be shown by an interaction between these factors.
Preliminary estimates of the power with 10 participants in each group, using the available information, were calculated using G*Power 3.1.
Assuming a correlation of 0.75 between pre- and post- measures (quite conservative for this group) there is power of 0.67 for detecting an interaction with an effect size f of 0.2 and 0.95 for an effect size f of 0.3.
All data will be entered into electronic databases at Curtin University with specialist statistical advice available from the Faculty of Health Sciences at Curtin University. A flow diagram will be used to report the number of participants enrolled in the study, randomised, and allocated to each group. Descriptive (e.g. means and standard deviations) and nonparametric statistics will be used to analyze the pre- and post-intervention data. Baseline demographic and clinical characteristics for study groups will be compared and reported to determine whether the two groups were equivalent at baseline. Statistical procedures will be used to compare groups for primary and secondary outcomes. Differences between participants receiving intervention vs. usual care will be examined using repeated measures ANOVA analyses with between subjects factors being intervention (usual care vs. experimental intervention) and the within subjects factor being measurement time-point (pre and post intervention, 4 week follow-up). For primary and secondary outcomes, the estimated effect sizes and associated 95% confidence intervals will be reported.

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)
WA
Recruitment hospital [1] 1599 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 7476 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 288144 0
Government body
Name [1] 288144 0
Western Australian Institute of Medical Research
Address [1] 288144 0
Western Australian Institute for Medical Research (WAIMR) Queen Elizabeth II Medical Centre (QEIIMC)
Hospital Avenue, Nedlands,
Perth 6009, Western Australia
Country [1] 288144 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street
PERTH
Western Australia 6000

Country
Australia
Secondary sponsor category [1] 286861 0
University
Name [1] 286861 0
Curtin University
Address [1] 286861 0
GPO Box U1987
PERTH
Western Australia. 6845
Country [1] 286861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290060 0
Royal Perth Hospital Human Ethics Committee
Ethics committee address [1] 290060 0
Wellington Street
PERTH
Western Australia 6000
Ethics committee country [1] 290060 0
Australia
Date submitted for ethics approval [1] 290060 0
Approval date [1] 290060 0
16/04/2013
Ethics approval number [1] 290060 0
REG 13-018
Ethics committee name [2] 290061 0
Curtin University Human Ethics committee
Ethics committee address [2] 290061 0
GPO Box U1987
PERTH
Western Australia. 6845
Ethics committee country [2] 290061 0
Australia
Date submitted for ethics approval [2] 290061 0
Approval date [2] 290061 0
27/03/2013
Ethics approval number [2] 290061 0
HR 44/2013

Summary
Brief summary
This project is a randomized control trial that will deliver and evaluate a highly innovative intervention for people with aphasia (i.e. loss of or reduction in the ability to use language) following stroke. Pilot work with the intervention, based around narrative structure and daily communication activities, has been successful in significantly improving language ability in everyday communication. The study will recruit 20 people with aphasia from Royal Perth Hospital and compare the novel protocol to usual speech pathology intervention. Outcomes will significantly refine future intervention with people with aphasia and facilitate translation of theory into routine clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43726 0
A/Prof Anne Whitworth
Address 43726 0
Curtin University
GPO Box U1987
PERTH
Western Australia 6000
Country 43726 0
Australia
Phone 43726 0
+61892663498
Fax 43726 0
Email 43726 0
anne.whitworth@curtin.edu.au
Contact person for public queries
Name 43727 0
A/Prof Anne Whitworth
Address 43727 0
Curtin University
GPO Box U1987
PERTH
Western Australia 6000
Country 43727 0
Australia
Phone 43727 0
+61892663498
Fax 43727 0
Email 43727 0
anne.whitworth@curtin.edu.au
Contact person for scientific queries
Name 43728 0
A/Prof Anne Whitworth
Address 43728 0
Curtin University
GPO Box U1987
PERTH
Western Australia 6000
Country 43728 0
Australia
Phone 43728 0
+61892663498
Fax 43728 0
Email 43728 0
anne.whitworth@curtin.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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6736 0
Whitworth, A., Leitao, S., Cartwright, J., Webster, J., Hankey, G. J., Zach, J., ... & Wolz, V. (2015). NARNIA: A new twist to an old tale. A pilot RCT to evaluate a multilevel approach to improving discourse in aphasia. Aphasiology, 29(11), 1345-1382.
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary