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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.
Scientific title
Impact of online face-to-face communication training for adults with hearing loss and their communication partners on hearing disability.
Secondary ID [1] 294312 0
HEARing CRC XR4.1.1a
Universal Trial Number (UTN)
U1111-1210-8189
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 307022 0
Condition category
Condition code
Ear 306126 306126 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300613 0
Rehabilitation
Intervention code [2] 300614 0
Lifestyle
Intervention code [3] 300615 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 305142 0
Level of hearing disability experienced by adults with hearing loss, as measured using the Hearing Handicap Questionnaire (Gatehouse & Noble, 2004)
Timepoint [1] 305142 0
Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Primary outcome [2] 305206 0
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)
Timepoint [2] 305206 0
Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [1] 344505 0
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.
Timepoint [1] 344505 0
4.5 months (3 months post-intervention)
Secondary outcome [2] 344506 0
Website usability, as measured using the System Usability Scale (SUS; Bangor, Kortum & Miller, 2008)(intervention group only)
Timepoint [2] 344506 0
Week 7 (immediately post-intervention)
Secondary outcome [3] 345030 0
Changes to capability for practicing face-to-face communication at home, as measured using a modified COM-B survey (Michie, Atkins & West, 2014)
Timepoint [3] 345030 0
Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [4] 345031 0
Changes to opportunity for practicing face-to-face communication at home, as measured using a modified COM-B survey (Michie, Atkins & West, 2014)
Timepoint [4] 345031 0
Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [5] 345032 0
Changes to motivation for practicing face-to-face communication at home, as measured using a modified COM-B survey (Michie, Atkins & West, 2014)
Timepoint [5] 345032 0
Baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [6] 345033 0
Use of face-to-face communication, as measured by the International Outcome Inventory - Alternative Interventions (IOI-AI) (Noble, 2002; Laplante-Levesque, Hickson & Worrall, 2012)
Timepoint [6] 345033 0
Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [7] 345034 0
Benefit from face-to-face communication, as measured by the International Outcome Inventory - Alternative Interventions (IOI-AI) (Noble, 2002; Laplante-Levesque, Hickson & Worrall, 2012)
Timepoint [7] 345034 0
Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [8] 345035 0
Residual activity limitations and participation restrictions, as measured by the International Outcome Inventory - Alternative Interventions (IOI-AI) (Noble, 2002; Laplante-Levesque, Hickson & Worrall, 2012)
Timepoint [8] 345035 0
Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)
Secondary outcome [9] 345036 0
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
Timepoint [9] 345036 0
Week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
Allocation via central randomisation by computer using REDcap software.
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
23/04/2018
Actual
22/06/2018
Date of last participant enrolment
Anticipated
31/10/2018
Actual
22/11/2018
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
1034
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298957 0
Other Collaborative groups
Name [1] 298957 0
The HEARing Cooperative Research Centre
Country [1] 298957 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
QLD 4072
Country
Australia
Secondary sponsor category [1] 298173 0
University
Name [1] 298173 0
The University of Melbourne
Address [1] 298173 0
550 Swanston Street
Department of Audiology and Speech Pathology
The University of Melbourne
Carlton
VIC 3053
Country [1] 298173 0
Australia
Other collaborator category [1] 280022 0
Government body
Name [1] 280022 0
Australian Hearing
Address [1] 280022 0
Australian Hearing
Level 5,
16 University Ave,
Macquarie university ,
NSW, 2109
Country [1] 280022 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299892 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 299892 0
Ethics committee country [1] 299892 0
Australia
Date submitted for ethics approval [1] 299892 0
30/01/2018
Approval date [1] 299892 0
09/03/2018
Ethics approval number [1] 299892 0
2018000176

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

Contacts
Principal investigator
Name 81890 0
Dr Carly Meyer
Address 81890 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Brisbane
Queensland 4072
Country 81890 0
Australia
Phone 81890 0
+61 7 3365 8547
Fax 81890 0
+61 7 3365 1877
Email 81890 0
[email protected]
Contact person for public queries
Name 81891 0
Carly Meyer
Address 81891 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Brisbane
Queensland 4072
Country 81891 0
Australia
Phone 81891 0
+61 7 3365 8547
Fax 81891 0
+61 7 3365 1877
Email 81891 0
[email protected]
Contact person for scientific queries
Name 81892 0
Carly Meyer
Address 81892 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Brisbane
Queensland 4072
Country 81892 0
Australia
Phone 81892 0
+61 7 3365 8547
Fax 81892 0
+61 7 3365 1877
Email 81892 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?

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.