Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12623001313628
Ethics application status
Approved
Date submitted
24/10/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring and monitoring aphasia services
Scientific title
Feasibility of implementing a comprehensive quality assessment toolkit for post-stroke aphasia services: a multi-centre pilot study with embedded mixed-methods process evaluation
Secondary ID [1] 310573 0
MRFF 2016134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 331430 0
Stroke 332009 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328173 328173 0 0
Speech therapy
Stroke 328746 328746 0 0
Haemorrhagic
Stroke 328747 328747 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will implement a method of measuring usual aphasia care using a minimum aphasia dataset. The minimum dataset comprises sociodemographic data (e.g., age, sex at birth, languages spoken), process of care indicators (e.g., use of standardised aphasia assessment tool, provision of aphasia education to patient/family) , treatment descriptors (e.g., type of aphasia treatment provided, number of aphasia treatment sessions) and core aphasia outcome measures (i.e., Western Aphasia Battery-Revised, Scenario Test, SAQoL-39g, GHQ-12). The minimum dataset will be collected only while the participant is an inpatient in a participating acute or subacute hospital/health service.

Participants may receive usual care aphasia intervention provided by hospital speech pathologists and/or other allied health professionals. The usual care aphasia interventions provided to participants will not be prescribed by the research team and will differ across participants and sites. The minimum dataset will capture details about usual care aphasia intervention.

Patient experience questionnaire
Participants (patients with aphasia) will also complete an aphasia-friendly patient experience questionnaire (one per participant) prior to completing their involvement in the study. This may occur in the acute hospital setting for patients being discharged directly to the community, or in the subacute setting for patients who receive subacute rehabilitation.

The questionnaire comprises six questions: 1) How easy was it for you to provide information and participate in the speech pathology tests? 2) How understandable were the questions and tests? 3) How helpful were the questions and tests in describing you and your aphasia? 4) How much did you enjoy answering the questions and completing the tests? 5) Was the amount of time it took to complete the tests acceptable? 6) How would you rate your overall satisfaction with the questions asked and the tests completed?

Participants will respond on a 5-point Likert scale with visual supports (to increase accessibility for people with aphasia).

In addition, there is one open-ended question: Do you have any other feedback you would like to share about your experience?

Patient experiences will contribute to the evaluation of the feasibility and acceptability of implementing the minimum dataset in clinical practice.
Intervention code [1] 326979 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336048 0
Composite primary outcome: Feasibility of administering the minimum dataset will be determined using various methods:
- Quality (determined using qualitative evaluation methods) and completeness (determined by the number of fields of minimum dataset data collected for each participant and site)
- Mixed-methods process evaluation using participant questionnaire to establish feasibility and acceptability of administering the minimum dataset. Assessed using a patient experience questionnaire designed for this study.
Timepoint [1] 336048 0
Feasibility of administering the minimum dataset will be assessed at the conclusion of data collection for all participants. The minimum dataset will be collected by hospital staff throughout each participant's hospital admission. The process evaluation surveys will be conducted at the time of the participants' discharge from hospital which will vary across participants.
Secondary outcome [1] 428839 0
N/A
Timepoint [1] 428839 0
N/a

Eligibility
Key inclusion criteria
Participants with aphasia
1) Aphasia as a result of a new stroke
2) Aged 18 years or older at the time of recruitment
3) Can demonstrate capacity to consent (by self or
via proxy - see consent process for details of consent via proxy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with aphasia
1) Presenting with aphasia resulting from a previous stroke
2) Presenting with a language impairment with an aetiology other than stroke
3) Medically unstable
4) Decreased alertness

Study design
Purpose
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 314782 0
Government body
Name [1] 314782 0
National Health and Medical Research Council (Medical Research Future Fund)
Country [1] 314782 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland, St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 317108 0
None
Name [1] 317108 0
Address [1] 317108 0
Country [1] 317108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313793 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 313793 0
Building 14 Rode Road CHERMSIDE QLD 4032
Ethics committee country [1] 313793 0
Australia
Date submitted for ethics approval [1] 313793 0
27/03/2023
Approval date [1] 313793 0
29/05/2023
Ethics approval number [1] 313793 0
HREC/2023/MNHB/95293

Summary
Brief summary
We will establish a person-centred approach to health service monitoring in aphasia services. Our team has developed a minimum aphasia dataset in partnership with stroke survivors with aphasia, their families, clinicians, and researchers. We will evaluate its implementation using a prospective, multi-centre, observational cohort study and a mixed-methods process evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129362 0
Dr Sarah J Wallace
Address 129362 0
Queensland Aphasia Research Centre, The University of Queensland, Level 7, 296 Herston Road, Herston, Queensland 4006
Country 129362 0
Australia
Phone 129362 0
+61 07 3346 7453
Fax 129362 0
Email 129362 0
[email protected]
Contact person for public queries
Name 129363 0
Sarah J Wallace
Address 129363 0
Queensland Aphasia Research Centre, The University of Queensland, Level 7, 296 Herston Road, Herston, Queensland 4006
Country 129363 0
Australia
Phone 129363 0
+61 7 3346 7453
Fax 129363 0
Email 129363 0
[email protected]
Contact person for scientific queries
Name 129364 0
Sarah J Wallace
Address 129364 0
Queensland Aphasia Research Centre, The University of Queensland, Level 7, 296 Herston Road, Herston, Queensland 4006
Country 129364 0
Australia
Phone 129364 0
+61 7 3346 7453
Fax 129364 0
Email 129364 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20729Study protocol    The protocol manuscript has been submitted for pub... [More Details]



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.