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Trial registered on ANZCTR


Registration number
ACTRN12611000833965
Ethics application status
Approved
Date submitted
8/08/2011
Date registered
8/08/2011
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Date results provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving communication between health practitioners, students and people with aphasia
Scientific title
The effects of communication partner training on communicative interactions between health professionals, health professional students and people with aphasia
Secondary ID [1] 262706 0
Nil
Universal Trial Number (UTN)
U1111-1123-1789
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 270411 0
Condition category
Condition code
Physical Medicine / Rehabilitation 270664 270664 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will investigate the effects of implementing a communication partner training program on the communicative interactions between people with aphasia, health professionals and health professional students. The component of the study that involves people with aphasia will consist of single group design, with all people with aphasia receiving the training program. During the study, the people with aphasia will complete a training program which consists of 6 modules (based on the Communication Partner Training Program developed by Connect in the United Kingdom). The modules will focus on developing strategies to assist communication. The modules will be delivered as group sessions facilitated by a qualified speech pathologist and will consist of 6 1-1.5 hour sessions over 6 weeks or 2-3 3 hour sessions depending upon the needs of the people with aphasia. The component of the study involving the health professionals will consist of a single group design, with all health professionals receiving the training program. In contrast, the component of the study that involves the health practitioner students will consist of a randomised control trial (with half of the students receiving the training program and the remaining half of the students acting as an untrained control group). To ensure equality, the students who are allocated to the control group will be offered the training program at the completion of the study. The health professionals and health professional students will attend a single training session (1.5 hours in duration and facilitated by a qualified speech pathologist) at the end of the program (they will not attend any other training sessions). During this session, the people with aphasia will teach the communication strategies to the health professionals and students.
Intervention code [1] 267050 0
Rehabilitation
Comparator / control treatment
For the health professional students, half of the students will completed the single training session with the people with aphasia. For comparison purposes, the remaining students will attend their usual lectures and not the training program (however, to ensure equality, a training program will be offered to the control group after the completion of the study). For the people with aphasia and health professionals, all participants in these groups will be trained (pre and post training measures will be collected for the people with aphasia and the health professionals rather than having a separate control group).
Control group
Active

Outcomes
Primary outcome [1] 269295 0
Change in self-rated communicative confidence (for all participants) eg. the Communication Confidence Rating Scale for Aphasia for the participants with aphasia, and a non-standardised rating scale developed specifically for this study for the health professionals and health professional students (the scale will consist of a 10cm long line ranging from "Not at all confident" through to "Very confident")
Timepoint [1] 269295 0
Pre-program, immediately post-program and 3 months later
Primary outcome [2] 269296 0
Change in self-rated knowledge and implementation of effective communication strategies (for all participants) as measured by a non-standardised rating scale developed specifically for this study (the scale will consist of a 10cm long line ranging from "Not at all confident" through to "Very confident"). The health professionals and students will also be asked to write down strategies and resources that could be used to facilitate communication with people with aphasia.
Timepoint [2] 269296 0
Pre-program, immediately post-program and 3 months later
Secondary outcome [1] 279322 0
Change in self-rated health-related quality of life for the people with aphasia (as measured by the EQ-5D and SS-QOL)
Timepoint [1] 279322 0
Pre-program, immediately post-program and 3 months later
Secondary outcome [2] 279323 0
Change in aphasia severity for the people with aphasia (as measured by the Western Aphasia Battery)
Timepoint [2] 279323 0
Pre-program, immediately post-program and 3 months later

Eligibility
Key inclusion criteria
The people with aphasia will have been diagnosed with aphasia by a speech pathologist. The health professionals will be health practitioners who are currently employed at the Princess Alexandra Hospital. The students will be second year or Graduate Entry Masters students who are currently enrolled in the speech pathology program at The University of Queensland and who have not completed block clinical placements with people with aphasia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For the people with aphasia, any individuals with severe comprehension or cognitive difficulties will be excluded. For the students, any individuals who have completed block clinical placements with people with aphasia will be excluded.

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)
For the people with aphasia and health professionals, all individuals who are enrolled in the study will participate in the training sessions. For the health professional students, half of the students will be randomly allocated to the training program during the study while the remaining students will act as a control group (the control group will be offered the training program at the completion of the study to ensure equality between the students). Allocation to the student groups will be concealed through the use of opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The people with aphasia and the health professionals will not be randomised (all as participants in these groups will receive the program), however, the students will be randomised using a computer-generated randomisation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
For the people with aphasia and the health professionals, a single group study design will be employed (as all participants in these groups will receive the training program). For the student component of the study, a parallel design will be used with half of the students receiving the training program during the study and the remaining half acting as a control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2011
Actual
23/09/2011
Date of last participant enrolment
Anticipated
Actual
26/10/2012
Date of last data collection
Anticipated
Actual
26/10/2012
Sample size
Target
120
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2294 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 267522 0
Government body
Name [1] 267522 0
Queensland Health Allied Health Clinical Education and Training Unit
Country [1] 267522 0
Australia
Funding source category [2] 289038 0
Charities/Societies/Foundations
Name [2] 289038 0
National Stroke Foundation
Country [2] 289038 0
Australia
Funding source category [3] 289039 0
Hospital
Name [3] 289039 0
Princess Alexandra Hospital Research Foundation Postgraduate Scholarship
Country [3] 289039 0
Australia
Primary sponsor type
Individual
Name
Emma Finch
Address
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 266564 0
Individual
Name [1] 266564 0
Jennifer Lethlean
Address [1] 266564 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 266564 0
Australia
Other collaborator category [1] 252133 0
Individual
Name [1] 252133 0
Steven McPhail
Address [1] 252133 0
Centre for Functioning and Health Research
Centro Buranda
Buranda QLD 4103
Country [1] 252133 0
Australia
Other collaborator category [2] 252134 0
Individual
Name [2] 252134 0
Jennifer Fleming
Address [2] 252134 0
Occupational Therapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [2] 252134 0
Australia
Other collaborator category [3] 252135 0
Individual
Name [3] 252135 0
Kyla Brown
Address [3] 252135 0
Division of Speech Pathology
The University of Queensland
St Lucia QLD 4072
Country [3] 252135 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269565 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 269565 0
Ethics committee country [1] 269565 0
Australia
Date submitted for ethics approval [1] 269565 0
Approval date [1] 269565 0
20/05/2011
Ethics approval number [1] 269565 0
Ethics committee name [2] 269566 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 269566 0
Ethics committee country [2] 269566 0
Australia
Date submitted for ethics approval [2] 269566 0
Approval date [2] 269566 0
22/07/2011
Ethics approval number [2] 269566 0

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

Contacts
Principal investigator
Name 32927 0
Dr Emma Finch
Address 32927 0
Speech Pathology Department Princess Alexandra Hospital
Ipswich Road Woolloongabba QLD 4102
Country 32927 0
Australia
Phone 32927 0
+61 7 3896 3133
Fax 32927 0
Email 32927 0
e.whiting@uq.edu.au
Contact person for public queries
Name 16174 0
Emma Finch
Address 16174 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 16174 0
Australia
Phone 16174 0
+61 7 3896 3133
Fax 16174 0
Email 16174 0
e.whiting@uq.edu.au
Contact person for scientific queries
Name 7102 0
Emma Finch
Address 7102 0
Speech Pathology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 7102 0
Australia
Phone 7102 0
+61 7 3896 3133
Fax 7102 0
Email 7102 0
e.whiting@uq.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
Data refers to health data so will not be publicly available


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
SourceTitleYear of PublicationDOI
EmbaseDoes communication partner training improve the conversation skills of speech-language pathology students when interacting with people with aphasia?.2017https://dx.doi.org/10.1016/j.jcomdis.2017.05.004
N.B. These documents automatically identified may not have been verified by the study sponsor.