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Trial registered on ANZCTR


Registration number
ACTRN12621000664842
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
1/06/2021
Date last updated
1/06/2021
Date data sharing statement initially provided
1/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a novel discourse intervention on everyday communication in people with dementia.
Scientific title
Evaluating the feasibility and effectiveness of a novel discourse intervention on everyday communication in people with dementia
Secondary ID [1] 303902 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 321486 0
Primary progressive aphasia 321487 0
Condition category
Condition code
Neurological 319240 319240 0 0
Dementias
Physical Medicine / Rehabilitation 319546 319546 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The NARNIA (Novel Approach to Real-life communication: Narrative Intervention in Aphasia) intervention approach is based upon established models of how language is organised and prepared for speaking and draws on the thinking processes that are used in everyday communication. NARNIA is a structured, yet highly interactive behavioural intervention that revolves around usual conversational speaking. The protocol uses discourse frameworks for everyday communication (i.e. giving opinions, explaining procedures, recounting personal memories) to scaffold and extend language output. This involves talking about recent experiences and events, different topics, including current affairs and opinion topics, and sharing stories from the person’s own life. A detailed NARNIA treatment protocol is followed.

Prior to the 10 week intervention period, participants will undergo two weeks of initial baseline assessment. A range of cognitive and language assessments will be completed, including the Curtin University Discourse Protocol and a self-report quality of life measure.

The intervention will be delivered by a research assistant (i.e. graduate speech pathologist) who will be trained in the treatment protocol provided with ongoing support throughout the project.

The intervention will be delivered individually and face to face in the participants' own home. The intervention will be delivered twice weekly over 10 weeks, for one hour. The intervention will be personalised for each participant, focusing on discourse topics that are meaningful to them and that align with their interests, current activities and upcoming events. This means that while the discourse genres targeted are standardised (e.g. procedures, opinions, recounts), the topics are personalised (e.g. opinions on politics vs. AFL). This will ensure the salience of intervention and specificity to their everyday communication.

Homework practice will be provided following each session, encouraging participants to practice the discourse topics and use of the discourse frameworks during everyday conversations. Participants will be provided with worksheets from the intervention sessions for reference where appropriate.

Treatment fidelity will be monitored by the chief investigator. One session per fortnight will be video recorded and coded against essential elements of the treatment protocol. Any deviation from the prescribed intervention protocol will be discussed with the research assistant and noted for statistical analysis.
Intervention code [1] 320208 0
Rehabilitation
Intervention code [2] 320462 0
Treatment: Other
Comparator / control treatment
No control group or control treatment.
Each participant will act as their own control. Participants will be assessed for a two week baseline period prior to starting the 10 week intervention.
Control group
Active

Outcomes
Primary outcome [1] 327110 0
The primary outcome measures involve analysis of Correct Information Units (CIUs) of language samples.

The first primary outcome measure is informativeness [%CIUs]

Timepoint [1] 327110 0
Pre treatment baseline period (week 1 and 2)
Immediately post treatment (week 13)
Follow up (week 17)
Primary outcome [2] 327403 0
The second primary outcome measure is efficiency [CIUs/min] of information communicated.

Analysis of CIUs has a long history and evidence base of use within the aphasia and dementia fields.
Timepoint [2] 327403 0
Pre treatment baseline period (week 1 and 2)
Immediately post treatment (week 13)
Follow up (week 17)
Secondary outcome [1] 393838 0
Secondary language outcome measures will be performed on standard language tasks (non-discourse) to measure change on tests of noun and verb processing.

The first secondary outcome is the Object and Action Naming Battery.
Timepoint [1] 393838 0
Pre treatment baseline period (week 1 and 2)
Immediately post treatment (week 13)
Follow up (week 17)
Secondary outcome [2] 393839 0
Secondary QoL outcomes will be measured using an aphasia-specific measure of QoL, the Assessment of Living with Aphasia (ALA), which is purposefully weighted towards social relationships (i.e. communication environment), participation in life roles, and life satisfaction, each of which are key dimensions of quality of life in aphasia. The ALA has established reliability and good internal consistency for all domains.
Timepoint [2] 393839 0
Pre treatment baseline period (week 1 and 2)
Immediately post treatment (week 13)
Follow up (week 17)
Secondary outcome [3] 394981 0
The second secondary outcome is the Northwestern Assessment of Verbs and Sentences
Timepoint [3] 394981 0
Pre treatment baseline period (week 1 and 2)
Immediately post treatment (week 13)
Follow up (week 17)
Secondary outcome [4] 394982 0
An semi-structured interview (exit interview) will be completed with participants at the completion of the study. This will help to establish feasibility and acceptability of the intervention.
Timepoint [4] 394982 0
Immediately post treatment (week 13)

Eligibility
Key inclusion criteria
Inclusion criteria: (1) clinical diagnosis of a dementia syndrome (i.e. major neurocognitive disorder, DSM-5), including Alzheimer’s disease, frontotemporal dementia and/or PPA or progressive language impairment (e.g. complaints of word finding and/or communication difficulties that are worsening over time), (2) early to moderate stage of disease progression as determined by the MMSE (13-25 points) or ACE-III (38-88 points; So et al., 2018), noting that cut off criteria may be adjusted for each participant based on their age and years of education in consultation with their medical specialist, (3) capacity to consent to participation as determined by their treating medical specialist, (4) normal or corrected hearing and vision, and (5) proficient in English (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
Exclusion criteria: (1) severe dementia (MMSE < 13; ACE-III <38; So et al., 2018), (2) primary impairment of apraxia of speech (AoS) or dysarthria, (3) a prior diagnosis of stroke, head injury or neurosurgery, and (4) clinically diagnosed major depression.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
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 intervention, e.g. social participation and life measures. A series of Geneneralized Linear Mixed Models (GLMMs) will be used to determine the main and interactive effects of time (baseline, immediately post-intervention, and maintenance) on discourse performance measures (%CIUs and CIUs/min). Qualitative data collected through the case history 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
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] 19070 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 33620 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 308294 0
Charities/Societies/Foundations
Name [1] 308294 0
Dementia Australia Research Foundation
Country [1] 308294 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987,
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 309099 0
None
Name [1] 309099 0
Address [1] 309099 0
Country [1] 309099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308267 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 308267 0
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 308267 0
Australia
Date submitted for ethics approval [1] 308267 0
Approval date [1] 308267 0
19/08/2020
Ethics approval number [1] 308267 0
Ethics committee name [2] 308268 0
Curtin University HREC
Ethics committee address [2] 308268 0
GPO Box U1987
Perth Western Australia 6845
Ethics committee country [2] 308268 0
Australia
Date submitted for ethics approval [2] 308268 0
Approval date [2] 308268 0
16/12/2020
Ethics approval number [2] 308268 0
HRE2020-0765

Summary
Brief summary
This study aims to modify and evaluate the feasibility and effectiveness of a highly novel therapy approach that has been trialled with other neurological populations (e.g. stroke, traumatic brain injury). The intervention is predicted to improve the informativeness and efficiency of everyday communication and quality of life in people living with early stage dementia. The study will recruit 15 adults with a diagnosis of dementia and progressive language impairment. Each participant will act as his or her own control. The study will provide pilot data to inform a future large-scale trial, help to optimise the treatment protocol, and discern the most appropriate candidates for the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110134 0
Dr Jade Cartwright
Address 110134 0
Curtin University
Curtin School of Allied Health
GPO Box U1987
Perth Western Australia 6845
Country 110134 0
Australia
Phone 110134 0
+61 8 9266 4631
Fax 110134 0
Email 110134 0
j.cartwright@curtin.edu.au
Contact person for public queries
Name 110135 0
Jade Cartwright
Address 110135 0
Curtin University
Curtin School of Allied Health
GPO Box U1987
Perth Western Australia 6845
Country 110135 0
Australia
Phone 110135 0
+61 8 9266 4631
Fax 110135 0
Email 110135 0
j.cartwright@curtin.edu.au
Contact person for scientific queries
Name 110136 0
Jade Cartwright
Address 110136 0
Curtin University
Curtin School of Allied Health
GPO Box U1987
Perth Western Australia 6845
Country 110136 0
Australia
Phone 110136 0
+61 8 9266 4631
Fax 110136 0
Email 110136 0
j.cartwright@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 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.