Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000526875
Ethics application status
Approved
Date submitted
27/01/2020
Date registered
5/05/2021
Date last updated
5/05/2021
Date data sharing statement initially provided
5/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Beyond NARNIA: Examining the effectiveness of a novel communication intervention for post-stroke aphasia in the clinical setting
Scientific title
Beyond NARNIA: Examining the effectiveness of a novel communication intervention for post-stroke aphasia in the clinical setting
Secondary ID [1] 300368 0
Nil
Universal Trial Number (UTN)
U1111-1247-2938
Trial acronym
Beyond NARNIA
Linked study record
The study ACTRN12613001263785 is the parent trial. The current study is a follow-up study to collect more data.

Health condition
Health condition(s) or problem(s) studied:
Aphasia 315985 0
Condition category
Condition code
Stroke 314262 314262 0 0
Ischaemic
Physical Medicine / Rehabilitation 316491 316491 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of Protocol: NARNIA (Novel Approach to Real-life communication: Narrative Intervention in Aphasia) is a behavioural intervention that revolves around usual conversational speaking, but provides structure and feedback to the client using frameworks that are conceptually different to usual aphasia intervention. The NARNIA intervention protocol aims to increase awareness and use of language structures across a diverse range of everyday speaking situations, focusing simultaneously on word, sentence and discourse levels. Descriptions and preliminary results of the NARNIA intervention have been published in journals but the full protocol is not currently available. Adaptations for group delivery have been developed where usual clinical service delivery at a site is via group therapy. The protocol will be delivered under two conditions: (1) in 1-to-1 therapy (Study 1) and (2) in group therapy (Study 2). All participants will be assessed using the same assessment battery and undergo the same intervention. Given the two service delivery modes, the data from participants treated in individual sessions and those treated within a group will be analysed separately. While all participants will be analysed individually, performance of individuals in the two separate conditions will be compared in two groups. As numbers may be small, however, these will provide preliminary data only on the comparison of service models.This study is different to the original study in not collecting control data from participants receiving 'usual care'. It is designed specifically to collect data on individuals undergoing the NARNIA intervention, with each individual being analysed using a single case design to identify patterns of responsiveness to the intervention.
Aims: The overall study will examine treatment effectiveness in a clinical setting, individual variability, and feasibility of group delivery of this approach.Two separate studies are being conducted based on individual or group service delivery. Study 1 will involve providing NARNIA intervention individually to 10 people who would receive usual individualised out-patient services. Study 2 will involve adapting the NARNIA intervention and delivering this within a group setting to 10 people (3-4 per group), receiving usual group-based out-patient services.
Design: A single-case experimental design will be used, using each participant as their own control.
Schedule: The NARNIA intervention protocol will be delivered twice-weekly by a qualified speech pathologist, individually in Study 1 and in small groups (3-4 participants per group) in Study 2, over 10 weeks (20 sessions in total). Each sessions will run for one hour.
Adherence to the intervention protocol is being carried out in both studies. Therapy integrity will be monitored by the research team via video recording of a subset of sessions. Essential data on client attendance and performance will be collected on standardised data collection forms by treating speech pathologists to record treatment dose for individuals. One session per fortnight per participant will be video-recorded and coded against required essential elements of the NARNIA intervention protocol to establish fidelity. Any deviation from the prescribed therapy protocol will be discussed with the speech pathology team and noted for statistical analysis. Regular feedback will be provided to all therapists by the Research team in regular support meetings.
Intervention code [1] 316653 0
Rehabilitation
Intervention code [2] 318231 0
Treatment: Other
Comparator / control treatment
Each participant will serve as their own control.
Control group
Active

Outcomes
Primary outcome [1] 322650 0
The same primary outcome measures will be collected on participants, irrespective of whether they undertake the intervention protocol in individual or group therapy.

(1) Change in frequency of macro structural language elements in samples of everyday discourse production, collected on the Curtin University Discourse Protocol (CUDP) (Whitworth et al, 2015). This is collected across 3 genres but is a composite score where the 3 genres (recounts, opinions, procedures) are collapsed into an everyday discourse composite score.
Timepoint [1] 322650 0
Post intervention - 12 weeks
Follow-up - 17 weeks
Primary outcome [2] 322651 0
(2) Change in Informativeness of discourse production, as measured by Percentage Correct Information Units (%CIUs) (Nicholas & Brookshire (1993) in samples collected on the CUDP. This s a composite score of the data collected across the 3 everyday discourse genres, and reflects the relative frequency of relevant words to non-relevant production, and (2) 'Efficiency' which is measured by CIUs per minute which is the average frequency of CIUs per minute of information communicated. This measure will enable comparison with other studies.
Timepoint [2] 322651 0
Post intervention - 12 weeks
Follow-up - 17 weeks
Primary outcome [3] 326689 0
(3) Change in Efficiency of discourse production, as measured by CIUs per minute (CIUs/min) in samples collected on the CUDP. This s a composite score of the data collected across the 3 everyday discourse genres, and is the the average frequency of CIUs/min of information communicated. This measure will enable comparison with other studies.
Timepoint [3] 326689 0
Post intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [1] 379184 0
The same secondary outcome measures will be collected on participants, irrespective of whether they undertake the intervention protocol in individual or group therapy.

(1) Change in frequency of correct naming performance on the Object and Action Naming Battery (Druks & Masterson, 2000). This tool permits the relative contribution of nouns and verbs to the overall score.
Timepoint [1] 379184 0
Post intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [2] 379186 0
(2) Change in frequency of correct scores on the Northwestern Assessment of Verbs and Sentences) (Thompson, 2011). This tool further permits examination of the relative contribution of sentence processing components to impairment in sentence processing..
Timepoint [2] 379186 0
Post-intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [3] 385302 0
(3) Change in the score on the Assessment of Living with Aphasia (ALA) (Simmons-Mackie et al, 2014). This tool encompasses a number of different domains (including social participation, communication activity, communication partners and is viewed as an overall measure of Quality of Life related to communication). It is purposefully weighted towards social relationships (i.e. communication environment), participation in life roles, and life satisfaction. These are reflected in an overall score.
Timepoint [3] 385302 0
Post-intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [4] 392370 0
(4) Change in frequency of overall amount of output, as measured by total words, in samples of everyday discourse production, collected on the CUDP (Whitworth et al, 2015). This is collected across 3 genres but is a composite score where the 3 genres (recounts, opinions, procedures) are collapsed into an everyday discourse composite score.
Timepoint [4] 392370 0
Post-intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [5] 392371 0
(5) Change in overall frequency of nouns used in samples of everyday discourse production, collected on the CUDP (Whitworth et al, 2015). This is collected across 3 genres but is a composite score where the 3 genres (recounts, opinions, procedures) are collapsed into an everyday discourse composite score.
Timepoint [5] 392371 0
Post-intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [6] 392372 0
(6) Change in overall frequency of verbs used in samples of everyday discourse production, collected on the CUDP (Whitworth et al, 2015). This is collected across 3 genres but is a composite score where the 3 genres (recounts, opinions, procedures) are collapsed into an everyday discourse composite score.
Timepoint [6] 392372 0
Post-intervention - 12 weeks
Follow-up - 17 weeks
Secondary outcome [7] 394049 0
(7) Feasibility of group delivery will be examined through a composite of (a) semi-structured interviews with participants and staff members delivering the group therapy at the end of each intervention period to collect qualitative data about treatment experiences and perceived challenges and benefits and (b) completion of a tailored Post-Study Questionnaire, based on the Post-Study Usability Questionnaire (PSSUQ)..
Timepoint [7] 394049 0
Post intervention - 12 weeks

Eligibility
Key inclusion criteria
(1) stroke defined by ICD-10 codes 161-164, (2) medically stable and suitable for rehabilitation, (3) >3 weeks post onset, with no upper limit for time post stroke, (4) mild-moderate aphasia of any type (>32.3 and <93.8 WAB-R-AQ16), participants with crossed aphasia will be eligible, (5) normal or corrected hearing and vision, and (6) proficient in English prior to stroke (used English in everyday communication [no interpreter required for therapy]).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) severe aphasia (<32.3 WAB-R-AQ), (2) primary impairment of apraxia of speech (AoS) or dysarthria, or moderate-severe AoS or dysarthria, (3) a prior diagnosis of dementia, head injury or neurosurgery, (4) a concurrent progressive neurological condition, (5) clinically diagnosed major depression, (8) current participation in an aphasia trial. Previous strokes will not exclude recruitment.

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)
Allocation is not concealed.
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
Other
Other design features
A within-subjects, multiple baseline across-behaviours research design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Each participant will be analysed as a single subject to investigate individual response to intervention. McNemar (two tailed) tests will be used where paired nominal data are present, e.g., picture naming, with Fisher Exact (two tailed) tests with Poisson distribution used on pairwise comparisons of unrelated data, e.g., discourse measures. A range of statistical analyses will be used to measure change in performance on other variables of interest in response to the novel intervention, e.g. social participation and life measures. A series of Geneneralized Linear Mixed Models will be used to determine the main and interactive effects of time (baseline, immediately post-intervention, and maintenance) on discourse performance measures (structural language measures, %CIUs and CIUs/min) and type of therapy delivery (individual, group). Qualitative data collected through the pre- and post-intervention semi-structured interviews will be transcribed verbatim and analysed using content thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15692 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 15693 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [3] 18831 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 18832 0
Osborne Park Hospital - Stirling
Recruitment postcode(s) [1] 29112 0
6150 - Murdoch
Recruitment postcode(s) [2] 29113 0
6160 - Fremantle
Recruitment postcode(s) [3] 33283 0
6009 - Nedlands
Recruitment postcode(s) [4] 33284 0
6021 - Stirling

Funding & Sponsors
Funding source category [1] 304793 0
Government body
Name [1] 304793 0
WA Health, Western Australian Government
Country [1] 304793 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street
Bentley WA 6013
Country
Australia
Secondary sponsor category [1] 305112 0
None
Name [1] 305112 0
Address [1] 305112 0
Country [1] 305112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305207 0
South Metropolitan Health Service HREC
Ethics committee address [1] 305207 0
St John of God Murdoch Hospital
14 Barry Marshall Place
MURDOCH, WA 6150
Ethics committee country [1] 305207 0
Australia
Date submitted for ethics approval [1] 305207 0
28/01/2020
Approval date [1] 305207 0
11/02/2020
Ethics approval number [1] 305207 0
RGS0000003850

Summary
Brief summary
A new approach to therapy for people with aphasia (language impairment after stroke) has been developed by our team which, when compared to usual car in a pilot trial, has provided highly promising evidence of greater gains in everyday speaking, participation in daily activities, and quality of life. The protocol, NARNIA (a Novel Approach to Real-life communication: Narrative Intervention in Aphasia), is a highly structured language therapy delivered using a natural interactive approach. As different service delivery models are in place within clinical settings, i.e. individual 1-to-1 therapy and group therapy, 10 people will receive individual therapy and 10 will receive group therapy. We aim to examine treatment effectiveness in a clinical setting, individual variability, and feasibility of group delivery of this approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99610 0
A/Prof Anne Whitworth
Address 99610 0
Curtin School of Allied Health
Faculty of Health Sciences
Curtin University
Kent St, BENTLEY, WA 6102
Country 99610 0
Australia
Phone 99610 0
+61 8 9266 3498
Fax 99610 0
Email 99610 0
[email protected]
Contact person for public queries
Name 99611 0
A/Prof Anne Whitworth
Address 99611 0
Curtin School of Allied Health
Faculty of Health Sciences
Curtin University
Kent St, BENTLEY, WA 6102
Country 99611 0
Australia
Phone 99611 0
+61 8 9266 3498
Fax 99611 0
Email 99611 0
[email protected]
Contact person for scientific queries
Name 99612 0
A/Prof Anne Whitworth
Address 99612 0
Curtin School of Allied Health
Faculty of Health Sciences
Curtin University
Kent St, BENTLEY, WA 6102
Country 99612 0
Australia
Phone 99612 0
+61 8 9266 3498
Fax 99612 0
Email 99612 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
HREC approval has been granted to enable aggregated, non-identifiable data from the project to be provided to Principal Investigators of other studies, on request and where ethical approval is in place, to address research questions examining aphasia intervention. With increasing use of aggregated data by research teams, it is anticipated that access to data from this study may be requested to contribute to meta-analyses and analysis of combined data, facilitating further advances in this area. Information has been included in the Participant Information Sheets and Consent Forms to ensure participants are informed and understand that this may happen. No information will be identifiable to individual participants.


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.