Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000951752p
Ethics application status
Submitted, not yet approved
Date submitted
22/06/2022
Date registered
6/07/2022
Date last updated
6/07/2022
Date data sharing statement initially provided
6/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Narrative Discourse Therapy for Patients in Post-Traumatic Amnesia (PTA): A feasibility study
Scientific title
Narrative Discourse Therapy for Patients in Post-Traumatic Amnesia (PTA): A feasibility study
Secondary ID [1] 307411 0
Nil Known
Universal Trial Number (UTN)
Nil Known
Trial acronym
NDT-PTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic amnesia 326742 0
Narrative discourse impairment 326743 0
Cognitive-communication impairment 326744 0
Traumatic Brain Injury 326745 0
Condition category
Condition code
Injuries and Accidents 323975 323975 0 0
Other injuries and accidents
Neurological 324106 324106 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will partake in a 30-minute 1:1 therapy sessions five times a week, aimed at developing narrative discourse skills, until they are deemed out of PTA (scoring 12 for 3 consecutive days on the Westmead PTA scale) or up to 10 sessions (whichever occurs first). The intervention will be delivered face-to-face. on our Acquired Brain Injury ward.

The therapy will be conducted by a member of the speech pathology team. The speech pathology team at Epworth HealthCare is experienced in cognitive-communication therapy and brain injury but will receive additional training and support. Training will occur through use of the manual and by the two Epworth Speech Pathologists involved in the study. The manual has been designed specifically for this study. Clinicians who will be administering the intervention will participate in 1x 60 minute face-to-face training session at least 2 weeks prior to delivering the first intervention.

Each treatment session will consist of the elements described below:

Part 1: Narrative discourse task with picture prompts
The participant will be shown a narrative picture sequence and then supported by the clinician to describe all the story elements. The participant will then be asked to tell the story from start to finish without any prompting, to see if they are able to retain the narrative structure and include the story elements. Note: participants will be shown a different narrative pictures sequence during each session.

Part 2: Narrative generation task
The participant will then be asked to tell the clinician a personal anecdote describing a time where they have had a similar experience to the story they just described. The clinician will document whether the patient included the same story elements as they were supported to do in the first task.

Where the intervention has been delivered by a clinician outside of the research team, a member of the research team will check-in with the clinician to ensure all measures have been completed accurately and respond to any queries from the clinician.

In addition to formal outcome measure for monitor tolerance and participation in the intervention by tracking the duration of each session and number of sessions attended.
Intervention code [1] 323848 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331777 0
Participation/ engagement using the Pittsburgh Rehabilitation Participation Scale (Lenze et al., 2004). A clinician-rated 6-point Likert-type item measuring patient participation in inpatient rehabilitation sessions.
Timepoint [1] 331777 0
Measured throughout each intervention session
Primary outcome [2] 331778 0
Agitation using the Agitated Behaviour Scale (Corrigan, 1989). A 14-item scale developed to monitor agitation during the acute phase of recovery from acquired brain injury.
Timepoint [2] 331778 0
Measured during each intervention session
Secondary outcome [1] 411094 0
Length of session assessed using a standard wall clock (record time at the start of the session and time at the end of the session to calculate duration).
Timepoint [1] 411094 0
Duration of each intervention session
Secondary outcome [2] 411095 0
Patient enjoyment of the intervention tasks- participants will be asked if they enjoyed the task (i.e. a yes/no response)
Timepoint [2] 411095 0
At the end of each intervention session
Secondary outcome [3] 411096 0
Narrative discourse skills will be assessed using the Flowerpot Story (Huber, W., and Gleber, J., 1982). This is an assessment of discourse structure which will be taken prior to treatment and then afterwards and the pre-post outcome measure. An audio recording will be taken to allow for analysis after the session.
Timepoint [3] 411096 0
Assessment using the flowerpot story will be completed prior to the first intervention session (between 1 and 3 days before commencing intervention and immediately post-intervention completion.
Secondary outcome [4] 411097 0
Task completion. Participants will be rated on how well they complete the therapy tasks on a scale of 0-2 (o = nil, 1 = partial and 2 = complete)
Timepoint [4] 411097 0
At the end of each intervention session
Secondary outcome [5] 411098 0
Number of sessions attended. Audit of session attendance checklist.
Timepoint [5] 411098 0
Cumulative data will be assessed at the conclusion of the study.

Eligibility
Key inclusion criteria
Has a next of kin who can provide consent to participate

Adequate communication to participate in structure therapy targeting narrative skills as determined by their treating speech pathologist

Ability to participate in a structured therapy session as determined by the clinician who is screening the patient

English speaking

Maximum score on The Westmead Post-Traumatic Amnesia Scale (WPTAS) <11 within 24 hours of admission

Adult (i.e. over 18 years old)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously diagnosed dementia or conditions impacting communication

Visual impairments which cannot be compensated for to see picture stimuli

Inability to sustain alertness for sufficient period of time to participate in the intervention

Medically unstable as determined by treating medical team

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/07/2022
Actual
Date of last participant enrolment
Anticipated
3/10/2022
Actual
Date of last data collection
Anticipated
14/10/2022
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22601 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 37860 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 311687 0
Charities/Societies/Foundations
Name [1] 311687 0
Epworth Medical Foundation
Country [1] 311687 0
Australia
Primary sponsor type
Hospital
Name
Epworth Healthcare
Address
89 Bridge Rd, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 313142 0
None
Name [1] 313142 0
n/a
Address [1] 313142 0
n/a
Country [1] 313142 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311141 0
Monash Health Ethics
Ethics committee address [1] 311141 0
Ethics committee country [1] 311141 0
Australia
Date submitted for ethics approval [1] 311141 0
25/05/2022
Approval date [1] 311141 0
Ethics approval number [1] 311141 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120086 0
Mrs Aashna Vazirani
Address 120086 0
Epworth Healthcare, 29 Erin Street, Richmond, VIC, 3121
Country 120086 0
Australia
Phone 120086 0
+61 03 9426 8726
Fax 120086 0
Email 120086 0
[email protected]
Contact person for public queries
Name 120087 0
Aashna Vazirani
Address 120087 0
Epworth Healthcare, 29 Erin Street, Richmond, VIC, 3121
Country 120087 0
Australia
Phone 120087 0
+61 03 9426 8726
Fax 120087 0
Email 120087 0
[email protected]
Contact person for scientific queries
Name 120088 0
Aashna Vazirani
Address 120088 0
Epworth Healthcare, 29 Erin Street, Richmond, VIC, 3121
Country 120088 0
Australia
Phone 120088 0
+61 03 9426 8726
Fax 120088 0
Email 120088 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor,

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal and for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available in published results in Jan/ Feb 2023, no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.