Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000062426
Ethics application status
Approved
Date submitted
3/12/2015
Date registered
21/01/2016
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Date results provided
17/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using people with aphasia to train health professionals in effective communication strategies over the internet
Scientific title
Efficacy of using people with aphasia to train health professionals in effective communication strategies over the internet
Secondary ID [1] 288050 0
None
Universal Trial Number (UTN)
U1111-1177-1850
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 296915 0
Aphasia 296916 0
Condition category
Condition code
Stroke 297152 297152 0 0
Ischaemic
Stroke 297204 297204 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 297564 297564 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health professionals from a variety of disciplines will be randomly allocated to groups (internet vs. face-to-face). All health professionals will attend an initial assessment session, a training session, and then a follow-up session. The initial assessment sessions will be held up to one week before the training session, while the follow-up session will occur approximately one week later. At the initial and follow-up assessment sessions, the health professionals will complete survey measures about their confidence when interacting with people with aphasia and knowledge about communication strategies. During the training session the health professionals will learn and implement communication strategies via a single 1 hour lecture by a speech pathologist and then a 15 minute conversation with a person with aphasia followed by feedback. The conversations will involve 1-2 health professionals paired with 1-2 people with aphasia in a small group format. The internet group will receive the training over the internet (this will involve watching a pre-recorded version of the training session online and then having a real-time conversation in a small group format with a person with aphasia (via Skype or a similar program) to practically implement the strategies. A register of attendance will be kept to monitor adherence to the intervention.
Intervention code [1] 293372 0
Other interventions
Comparator / control treatment
Health professionals in the control group will attend an initial assessment session, a training session, and then a follow-up session. At the initial and follow-up assessment sessions, the health professionals will complete survey measures about their confidence when interacting with people with aphasia and knowledge about communication strategies. During the training session the health professionals will learn and implement communication strategies via a single 1 hour lecture by a speech pathologist and then a 15 minute conversation with a person with aphasia followed by feedback. The control group will receive the training in the traditional face to face format delivered by a speech pathologist physically present in the room with participants. During the conversation, the people with aphasia will be physically present in the room with the health professional.
Control group
Active

Outcomes
Primary outcome [1] 296768 0
Change in confidence when communicating with people with aphasia using a customised 100mm visual analogue scale
Timepoint [1] 296768 0
Immediately before receiving the training and then immediately after the training.
Primary outcome [2] 296769 0
Change in knowledge about effective strategies for communicating with people with aphasia (in the form of an open-ended content question)
Timepoint [2] 296769 0
Immediately before the training and immediately after receiving the training
Secondary outcome [1] 319295 0
Self-rated success of the communication partner training program by the person with aphasia on a customised 100mm visual anologue scale.
Timepoint [1] 319295 0
Immediately after the person with aphasia has participated in the conversation with the health professional

Eligibility
Key inclusion criteria
Participants will be Health professionals from a variety of allied health disciplines employed at the Princess Alexandra (PA) Hospital (Brisbane, Queensland). The people with aphasia will be currently attending an outpatient communication group at the Princess Alexandra Hospital. The people with aphasia will all be diagnosed with aphasia by a speech pathologist prior to their inclusion in the study and will not have any other neurological or developmental conditions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health professionals - inadequate English skills to consent and participate in the program; history of neurological conditions. People with aphasia - inadequate English skills to consent and participate in the program; history of other neurological or developmental conditions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computerised random number generator will be used to determine group allocation, which will be concealed at the time of recruitment using opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The visual analogue scale data will initially be analysed using descriptive statistics (mean, SD, range). The confidence visual analogue data will be analysed using repeated measures ANOVAs (or non-parametric equivalent) with between group comparisons (internet, face to face) and time (pre, post) as the repeated measure. The people with aphasia visual analogue scale data will be analysed using independent samples t tests (or non-parametric equivalent) (internet, face to face). The knowledge questions will be analysed descriptively using thematic analysis. Sample size calculations were based primarily upon current clinical numbers and feasibility. A sample size calculation for this project is somewhat speculative in the absence of pilot data. The study requires 54 complete data sets (90% completion rate from the 60 participants) to achieve 80% power to detect a between group difference of 7.9mm on the primary outcome visual analogue scale (assuming a standard deviation of 14mm, 1:1 allocation ratio, and 0.68 correlation between baseline and follow-up assessments).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/05/2013
Date of last participant enrolment
Anticipated
29/02/2016
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
60
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4832 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 12338 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 292495 0
Charities/Societies/Foundations
Name [1] 292495 0
National Stroke Foundation
Country [1] 292495 0
Australia
Funding source category [2] 292496 0
Charities/Societies/Foundations
Name [2] 292496 0
Princess Alexandra Hospital Research Support Scheme Postgraduate Scholarship
Country [2] 292496 0
Australia
Primary sponsor type
Individual
Name
Emma Finch
Address
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba
Queensland 4102
Country
Australia
Secondary sponsor category [1] 291205 0
Individual
Name [1] 291205 0
Ms Ashley Cameron
Address [1] 291205 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba
Queensland 4102
Country [1] 291205 0
Australia
Other collaborator category [1] 278740 0
Individual
Name [1] 278740 0
Dr Kyla Brown
Address [1] 278740 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country [1] 278740 0
Australia
Other collaborator category [2] 278741 0
Individual
Name [2] 278741 0
Dr Steven McPhail
Address [2] 278741 0
Centre for Functioning and Health Research
Metro South Hospital and Health Service
Country [2] 278741 0
Australia
Other collaborator category [3] 278742 0
Individual
Name [3] 278742 0
Dr Jennifer Lethlean
Address [3] 278742 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country [3] 278742 0
Australia
Other collaborator category [4] 278743 0
Individual
Name [4] 278743 0
Associate Professor Jennifer Fleming
Address [4] 278743 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country [4] 278743 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293961 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 293961 0
Ethics committee country [1] 293961 0
Australia
Date submitted for ethics approval [1] 293961 0
28/12/2012
Approval date [1] 293961 0
29/01/2013
Ethics approval number [1] 293961 0
HREC/10/QPAH/329
Ethics committee name [2] 293962 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 293962 0
Ethics committee country [2] 293962 0
Australia
Date submitted for ethics approval [2] 293962 0
06/02/2013
Approval date [2] 293962 0
14/02/2013
Ethics approval number [2] 293962 0
2011000801

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

Contacts
Principal investigator
Name 61646 0
Dr Emma Finch
Address 61646 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 61646 0
Australia
Phone 61646 0
+61 7 3896 3133
Fax 61646 0
Email 61646 0
[email protected]
Contact person for public queries
Name 61647 0
Emma Finch
Address 61647 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 61647 0
Australia
Phone 61647 0
+61 7 3896 3133
Fax 61647 0
Email 61647 0
[email protected]
Contact person for scientific queries
Name 61648 0
Emma Finch
Address 61648 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 61648 0
Australia
Phone 61648 0
+61 7 3896 3133
Fax 61648 0
Email 61648 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
Individual participant data will not be available as the data are health data


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.