Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000130460
Ethics application status
Approved
Date submitted
16/12/2015
Date registered
4/02/2016
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Date results provided
17/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Training students in effective communication strategies via telehealth
Scientific title
Efficacy of using people with aphasia to train healthcare students in effective communication strategies over the internet
Secondary ID [1] 288164 0
None
Universal Trial Number (UTN)
U1111-1177-7004
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 297072 0
aphasia 297073 0
Condition category
Condition code
Stroke 297303 297303 0 0
Haemorrhagic
Stroke 297304 297304 0 0
Ischaemic
Physical Medicine / Rehabilitation 297305 297305 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: The students will participate in a theoretical lecture about strategies to communicate effectively with people with aphasia. The lecture will be delivered face-to-face by a fully qualified speech pathologist for no more than 1 hour in duration. Following the lecture, all students will have a conversation with 1-2 people with aphasia. The conversations will occur up to one week after the lecture. The students will be in groups of 1-2 students per conversation. The conversations will be conducted over the internet using eHAB software, with the students being at The University of Queensland while the people with aphasia will be at the Princess Alexandra Hospital. The conversations will run for approximately 10 minutes and involve 5 minutes of general conversation followed by 5 minutes of clinical questioning. During the clinical questioning, the students will ask the people with aphasia up to 5 questions to obtain information (e.g., what is your address? How many stairs do you have at home?). Following the conversation, the people with aphasia will provide the students with verbal and visual feedback about their use of conversation strategies. The students then will complete a reflective note about their learning experience before they complete the final outcome measures. To monitor adherence to the study a register of attendance at the lecture and conversation will be kept.
Intervention code [1] 293472 0
Other interventions
Comparator / control treatment
Participants in control group will attend the same training as the intervention group, however, at the completion of the training program, participants in the control group will not receive any feedback from the people with aphasia. The students in control group will participate in a theoretical lecture about strategies to communicate effectively with people with aphasia. The lecture will be delivered face-to-face by a fully qualified speech pathologist for a maximum duration of one hour. Following the lecture, all students will have a conversation with 1-2 people with aphasia. The conversations will occur up to one week after the lecture. The students will be in groups of 1-2 students per conversation. The conversations will be conducted over the internet using eHAB software, with the students being at The University of Queensland while the people with aphasia will be at the Princess Alexandra Hospital. The conversations will run for approximately 10 minutes and involve 5 minutes of general conversation followed by 5 minutes of clinical questioning. During the clinical questioning, the students will ask the people with aphasia up to 5 questions to obtain information (e.g., what is your address? How many stairs do you have at home?). Following the conversation, students will not be provided with feedback about their conversation with the people with aphasia, nor will they watch a reflective video of their conversation. However, the students will complete a reflective note about their learning experience before they complete the final outcome measures. To monitor adherence to the study a register of attendance at the lecture and conversation will be kept.
Control group
Active

Outcomes
Primary outcome [1] 296875 0
Change in confidence when communicating with people with aphasia using a customised 100mm visual analogue scale
Timepoint [1] 296875 0
Immediately before receiving the training and then immediately after the training.
Primary outcome [2] 296876 0
Change in knowledge about effective strategies for communicating with people with aphasia (in the form of an open-ended content question)
Timepoint [2] 296876 0
Immediately before receiving the training and then immediately after the training.
Secondary outcome [1] 319581 0
Analysis of the students’ conversations with people with aphasia according to the Kagan scales (the students’ skill in providing support for the person with aphasia during the conversation and the level of participation of the person with aphasia in the conversation) (Kagan et al., 2004). The analyses will be conducted by a research assistant who is trained in using the scales.
Timepoint [1] 319581 0
During the conversations with the people with aphasia.
Secondary outcome [2] 319582 0
The students’ effectiveness communicating during the conversations will be also rated according to Compass Assessment in Speech Pathology (COMPASS) Professional Competency Unit 2 Communication Element 2.1 (Use of interpersonal communication skills to facilitate the effective practice of speech pathology) by the members of the project team. COMPASS is the psychometrically validated competency-based assessment tool used to evaluate student performance on clinical placements Australia-wide, including at UQ and on UQ-organised industry placements (Speech Pathology Australia, 2014).
Timepoint [2] 319582 0
During the conversations with the people with aphasia.
Secondary outcome [3] 319583 0
The students’ abilities to use the telehealth technology will be evaluated through observational checklists developed by the project team.
Timepoint [3] 319583 0
During the conversations with the people with aphasia.
Secondary outcome [4] 320023 0
Analysis of the students’ conversations with people with aphasia according to conversation breakdowns and repairs (Cunningham & Ward, 2003). This analysis will be conducted by a research assistant who is trained in using the approach.
Timepoint [4] 320023 0
During the conversations with the people with aphasia.
Secondary outcome [5] 327899 0
Standardised Patient Interview Rating Scale (SPIRS)
Timepoint [5] 327899 0
During the conversations with the people with aphasia.

Eligibility
Key inclusion criteria
Students (Intervention and control groups): Students who are in the second or third year of study in the speech pathology program and are currently attending lectures about aphasia at The University of Queensland.

People with aphasia: diagnosed with aphasia by a speech pathologist prior to their inclusion in the study with no 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
Students (Intervention and control groups): 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
Power calculations for a medium effect size (0.26) with an alpha level of 0.05, power of 0.80 for a repeated measures ANOVA with within-between interactions indicated that a sample size of 32 participants is required. To allow for participant drop out and the fact that not all students enrolled in the course will wish to participate in the project, all students enrolled in the course (n = 100) will be approached about potential participation in the study.

The students' confidence when communicating with aphasia according to a 100mm visual analogue scale will be recorded before and immediately after the conversations with the people with aphasia. Changes in conversation ratings between the 2 groups at these time point will be analysed using a repeated measures ANOVA (or non-parametric equivalent if the data are not normally distributed).

The students’ knowledge of effective communication strategies for communicating with people with aphasia before and after the conversations using a written free recall question (i.e., List strategies for communicating with a person with aphasia) will be analysed using repeated measures ANOVAs (or non-parametric equivalent if the data are not normally distributed).

The students’ videotaped conversations with people with aphasia will be analysed according to: (a) the Kagan scales (the students’ skill in providing support for the person with aphasia during the conversation and the level of participation of the person with aphasia in the conversation) (Kagan et al., 2004) and (b) conversation breakdowns and repairs (Cunningham & Ward, 2003). Potential differences between the groups on these measures will be compared descriptively.

The students’ effectiveness communicating during the conversations will be also rated according to Compass Assessment in Speech Pathology (COMPASS) Professional Competency Unit 2 Communication Element 2.1 (Use of interpersonal communication skills to facilitate the effective practice of speech pathology) by the members of the project team. COMPASS is the psychometrically validated competency-based assessment tool used to evaluate student performance on clinical placements Australia-wide, including at UQ and on UQ-organised industry placements (Speech Pathology Australia, 2014). Potential differences between the groups on these measures will be compared descriptively using differences in ratings.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
4/07/2016
Actual
4/07/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
23/09/2016
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
100
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4971 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 12464 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 292568 0
University
Name [1] 292568 0
The University of Queensland
Country [1] 292568 0
Australia
Primary sponsor type
Individual
Name
Emma Finch
Address
School of Health and Rehabilitation Sciences
The University of Queensland, St Lucia, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 291291 0
None
Name [1] 291291 0
Address [1] 291291 0
Country [1] 291291 0
Other collaborator category [1] 278732 0
Individual
Name [1] 278732 0
Ashley Cameron
Address [1] 278732 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba
Queensland 4102
Country [1] 278732 0
Australia
Other collaborator category [2] 278733 0
Individual
Name [2] 278733 0
Jennifer Lethlean
Address [2] 278733 0
Speech Pathology Department
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba
Queensland 4102
Country [2] 278733 0
Australia
Other collaborator category [3] 278734 0
Individual
Name [3] 278734 0
Kyla Hudson
Address [3] 278734 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
Country [3] 278734 0
Australia
Other collaborator category [4] 278735 0
Individual
Name [4] 278735 0
Tanya Rose
Address [4] 278735 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
Country [4] 278735 0
Australia
Other collaborator category [5] 278736 0
Individual
Name [5] 278736 0
Jennifer Fleming
Address [5] 278736 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
Country [5] 278736 0
Australia
Other collaborator category [6] 278737 0
Individual
Name [6] 278737 0
David Copland
Address [6] 278737 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
Country [6] 278737 0
Australia
Other collaborator category [7] 278738 0
Individual
Name [7] 278738 0
Deborah Theodoros
Address [7] 278738 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Brisbane, QLD 4072
Country [7] 278738 0
Australia
Other collaborator category [8] 278739 0
Individual
Name [8] 278739 0
Steven McPhail
Address [8] 278739 0
Centre for Functioning and Health Research
Metro South Health
Suite 304
Level 3, Buranda Village
Cnr Ipswich Road and Cornwall Street
Buranda QLD 4102
Country [8] 278739 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294046 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 294046 0
Ethics committee country [1] 294046 0
Australia
Date submitted for ethics approval [1] 294046 0
30/11/2015
Approval date [1] 294046 0
01/12/2015
Ethics approval number [1] 294046 0
HREC/10/QPAH/329
Ethics committee name [2] 294047 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 294047 0
Ethics committee country [2] 294047 0
Australia
Date submitted for ethics approval [2] 294047 0
10/12/2015
Approval date [2] 294047 0
14/12/2015
Ethics approval number [2] 294047 0
2011000801

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

Contacts
Principal investigator
Name 62238 0
Dr Emma Finch
Address 62238 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country 62238 0
Australia
Phone 62238 0
+61 7 3896 3133
Fax 62238 0
Email 62238 0
[email protected]
Contact person for public queries
Name 62239 0
Emma Finch
Address 62239 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country 62239 0
Australia
Phone 62239 0
+61 7 3896 3133
Fax 62239 0
Email 62239 0
[email protected]
Contact person for scientific queries
Name 62240 0
Emma Finch
Address 62240 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country 62240 0
Australia
Phone 62240 0
+61 7 3896 3133
Fax 62240 0
Email 62240 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
The data refer to health data so will not be shared


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.