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Trial registered on ANZCTR
Registration number
ACTRN12618000583246
Ethics application status
Approved
Date submitted
23/03/2018
Date registered
16/04/2018
Date last updated
22/03/2019
Date data sharing statement initially provided
20/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of hearing rehabilitation services for adults with hearing loss and their communication partners.
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Scientific title
Impact of online face-to-face communication training for adults with hearing loss and their communication partners on hearing disability.
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Secondary ID [1]
294312
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HEARing CRC XR4.1.1a
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Universal Trial Number (UTN)
U1111-1210-8189
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing loss
307022
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Condition category
Condition code
Ear
306126
306126
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0
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A randomised controlled trial will be used to evaluate the impact of an online face-to-face communication training program (HEARhelp Online).
The objective of HEARhelp Online is to increase face-to-face communication around the home and reduce communication disability. It comprises of 5 x 30 minutes online modules, which participants will work through over a five week period (1 per week) in a location of their choice (e.g., own home, family member's home). Participants will complete the modules as a dyad, consisting of an adult with hearing loss and a nominated communication partner (who may or may not have a hearing loss). Dyads are able to work through the online modules together or independently, however they will need to complete the majority of the home activities jointly.
The modules/topics covered in the program are: 1) Understanding why face-to-face communication is important, (2) Preparing for regular face-to-face communication at home, (3) How to speak face-to-face at home to achieve your goals, (4) Preparing the environment for face-to-face communication, and (5) Preparing to speak face-to-face now and into the future. Within each module there is written information, images, in-session activities and home activities. Some modules also include video examples demonstrating good and bad face-to-face communication. The activities dyads will be asked to complete include: monitoring and reflecting on their own communication, goal setting and action planning for face-to-face communication, practicing of face-to-face communication and making changes to room layouts in their home to promote face-to-face communication.
Adherence to the training will be monitored using website analytics (e.g. frequency with which participants log into modules; time taken to complete modules) and by reviewing written booklets at completion of the intervention.
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Intervention code [1]
300613
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Rehabilitation
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Intervention code [2]
300614
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Lifestyle
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Intervention code [3]
300615
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Behaviour
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Comparator / control treatment
Control condition is treatment as usual where participants will be able to continue receiving standard audiological rehabilitation as per Audiology Australia's Recommended Standards for Clinical Practice (http://audiology.asn.au/index.cfm/resources-publications/professional-resources/professional-practice-standards/). All participants assigned to the control condition will be given the opportunity to participate in the HEARhelp Online training once data collection is complete.
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Control group
Active
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Outcomes
Primary outcome [1]
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Level of hearing disability experienced by adults with hearing loss, as measured using the Hearing Handicap Questionnaire (Gatehouse & Noble, 2004)
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Assessment method [1]
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Timepoint [1]
305142
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Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Primary outcome [2]
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Level of third party disability experienced by communication partners of adults with hearing loss (participants with no hearing loss only), as measured by the Significant Other Scale for Hearing Disability (SOS-HEAR; Scarinci, Worrall & Hickson, 2009)
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Assessment method [2]
305206
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Timepoint [2]
305206
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Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [1]
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Actions taken by adults with hearing loss and their communication partners as a result of participating in the HEARhelp Online training (intervention group only), as measured by a study specific questionnaire and semi-structured, in-depth interviews.
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Assessment method [1]
344505
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Timepoint [1]
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4.5 months (3 months post-intervention)
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Secondary outcome [2]
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Website usability, as measured using the System Usability Scale (SUS; Bangor, Kortum & Miller, 2008)(intervention group only)
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Assessment method [2]
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Timepoint [2]
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Week 7 (immediately post-intervention)
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Secondary outcome [3]
345030
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Changes to capability for practicing face-to-face communication at home, as measured using a modified COM-B survey (Michie, Atkins & West, 2014)
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Assessment method [3]
345030
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Timepoint [3]
345030
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Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [4]
345031
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Changes to opportunity for practicing face-to-face communication at home, as measured using a modified COM-B survey (Michie, Atkins & West, 2014)
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Assessment method [4]
345031
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Timepoint [4]
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Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [5]
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Changes to motivation for practicing face-to-face communication at home, as measured using a modified COM-B survey (Michie, Atkins & West, 2014)
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Assessment method [5]
345032
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Timepoint [5]
345032
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Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [6]
345033
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Use of face-to-face communication, as measured by the International Outcome Inventory - Alternative Interventions (IOI-AI) (Noble, 2002; Laplante-Levesque, Hickson & Worrall, 2012)
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Assessment method [6]
345033
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Timepoint [6]
345033
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Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [7]
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Benefit from face-to-face communication, as measured by the International Outcome Inventory - Alternative Interventions (IOI-AI) (Noble, 2002; Laplante-Levesque, Hickson & Worrall, 2012)
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Assessment method [7]
345034
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Timepoint [7]
345034
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Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [8]
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Residual activity limitations and participation restrictions, as measured by the International Outcome Inventory - Alternative Interventions (IOI-AI) (Noble, 2002; Laplante-Levesque, Hickson & Worrall, 2012)
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Assessment method [8]
345035
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Timepoint [8]
345035
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Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Secondary outcome [9]
345036
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Economic evaluation of HEARhelp Online, as measured by questions on benefits and costs associated with hearing rehabilitation services, derived from a range of sources and purposefully integrated for this study
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Assessment method [9]
345036
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Timepoint [9]
345036
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Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
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Eligibility
Key inclusion criteria
Participants must sign up to the study as a dyad, of which:
At least one member of the dyad has a self-reported hearing disability
At least one member of the dyad experiences self-reported communication difficulties at home
Both members of the dyad are over 18 years old
Both members of the dyad reside in Australia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
One or both members of the dyad has no access to the Internet
One or both members of the dyad reside in an aged care facility
Participant is not part of a dyad who have both consented to the study
Although not a strict inclusion/exclusion criteria, adults with hearing loss will be encouraged to nominate a communication partner who they live with or see frequently, who will also participate in the study.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation via central randomisation by computer using REDcap software.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be stratified by hearing aid ownership (hearing aid owner vs, non-owner). Participants will be randomised at a dyad level, based on the hearing aid ownership of the participant with hearing loss (if both have a hearing loss, it will be based on the first participant to sign up to the study).
A randomisation table will be created using computer software (Stata).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Participants will include a maximum of 517 dyads (i.e., 1034 participants), based on a power of 0.8, type 1 error of 0.01, a time trend by treatment hypothesis, and an expectation that the treatment group will be 2.8 points lower on the primary response variable (HHQ) at the final assessment point (T3), compared to the control group (based on results of communication education program; Hickson, Worrall & Scarinci, 2007), modelled on a Mixed Effects model. NB: A more accurate sample size will be calculated, based on the results of the first 50 participants who enrol in the study.
An intention to treat analysis will be used.
Two subject-specific mixed effects models will be applied to compare the control group to the intervention group (HEARhelp Online) on levels of hearing disability experienced by adults with hearing loss and their communication partners.
To compare the cost-effectiveness of the control group and intervention group (HEARhelp Online) for adults with hearing loss and their communication partners, we will consider benefits (e.g. decreased in hearing disability, increased hearing aid use, decreased hearing aid returns) in the context of the costs associated with audiology appointments (e.g. audiologist time, client time, client travel).
To evaluate the usability of HEARhelp Online, the System Usability Scale will be analysed using descriptive statistics.
A series of two-way mixed ANOVAs will compare group differences (control group vs. intervention group) on self-perceived levels of capability, opportunity and motivation.
A two-way mixed ANOVA will compare group differences (control vs. intervention group) on face-to-face communication outcomes (e.g., use, benefit).
The qualitative interviews will be transcribed verbatim and analysed using thematic analysis to explore the actions taken by adults with hearing loss and their communication partners as a result of participating in HEARhelp Online.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
23/04/2018
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Actual
22/06/2018
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Date of last participant enrolment
Anticipated
31/10/2018
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Actual
22/11/2018
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Date of last data collection
Anticipated
31/01/2019
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Actual
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Sample size
Target
1034
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
298957
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Other Collaborative groups
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Name [1]
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The HEARing Cooperative Research Centre
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Address [1]
298957
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550 Swanston Street
Department of Audiology and Speech Pathology
The University of Melbourne
Carlton
VIC 3053
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Country [1]
298957
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
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Country
Australia
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Secondary sponsor category [1]
298173
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University
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Name [1]
298173
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The University of Melbourne
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Address [1]
298173
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550 Swanston Street
Department of Audiology and Speech Pathology
The University of Melbourne
Carlton
VIC 3053
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Country [1]
298173
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Australia
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Other collaborator category [1]
280022
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Government body
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Name [1]
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Australian Hearing
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Address [1]
280022
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Australian Hearing
Level 5,
16 University Ave,
Macquarie university ,
NSW, 2109
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Country [1]
280022
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299892
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University of Queensland Human Research Ethics Committee
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Ethics committee address [1]
299892
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Office of Research Ethics
The University of Queensland
Cumbrae-Stewart Building #72
Brisbane
Queensland 4072
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Ethics committee country [1]
299892
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Australia
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Date submitted for ethics approval [1]
299892
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30/01/2018
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Approval date [1]
299892
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09/03/2018
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Ethics approval number [1]
299892
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2018000176
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Summary
Brief summary
This project aims to evaluate an online face-to-face communication training program (HEARhelp Online) for adults with hearing loss an their communication partners. HEARhelp Online is a simple, web-based intervention that addresses the need to make people more aware to speak to someone with hearing loss face-to-face. It is specifically tailored dyads comprising of an adult with hearing loss and a frequent communication partner and aims to improve face-to-face communication around the home. Participants will include a maximum of 517 dyads, who will be randomised to either the intervention group (HEARhelp Online + treatment as usual) or the control group (treatment as usual). Dyads in the intervention group will complete 5 online modules (which include information, videos and activities) over a 5 week period.
It is hypothesised that participating in the HEARhelp Online training program (+ treatment as usual) will: (1) lead to significantly greater decrease in hearing disability experienced by adults with hearing loss and their communication partners, compared to the control group (treatment as usual), (2) Be more cost-effective, compared to control group (treatment as usual), (3) be associated with positive changes in capability, opportunity and motivation, and (4) be associated with positive changes in use of face-to-face communication training.
Participants will be asked to complete surveys at baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention). Participants may also be invited to participate in an interview at 4.5 months (3 months post-intervention). Data will be analysed using descriptive statistics, mixed effects models, a series of two-way mixed ANOVAs and qualitative interviews.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Carly Meyer
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Address
81890
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School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Brisbane
Queensland 4072
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Country
81890
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Australia
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Phone
81890
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+61 7 3365 8547
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Fax
81890
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+61 7 3365 1877
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Email
81890
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[email protected]
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Contact person for public queries
Name
81891
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Dr Carly Meyer
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Address
81891
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School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Brisbane
Queensland 4072
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Country
81891
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Australia
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Phone
81891
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+61 7 3365 8547
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Fax
81891
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+61 7 3365 1877
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Email
81891
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[email protected]
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Contact person for scientific queries
Name
81892
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Dr Carly Meyer
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Address
81892
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School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Brisbane
Queensland 4072
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Country
81892
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Australia
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Phone
81892
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+61 7 3365 8547
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Fax
81892
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+61 7 3365 1877
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Email
81892
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
Download to PDF