Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001139561p
Ethics application status
Submitted, not yet approved
Date submitted
7/08/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The HearChoice trial: A patient decision support intervention to address decision-making in hearing healthcare
Scientific title
The HearChoice trial: an evaluation of the clinical effectiveness of a patient decision support intervention on help-seeking and decisional conflict in adults with hearing loss
Secondary ID [1] 312312 0
NHMRC 2021 Hearing Health Evidence Based Support Service grant identification number: 2015748.
Universal Trial Number (UTN)
U1111-1309-5316
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 334067 0
Condition category
Condition code
Ear 330733 330733 0 0
Deafness
Public Health 330749 330749 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HearChoice: an online, modular, patient decision-support intervention for adults with hearing loss. Participants will independently access HearChoice via their smartphone, tablet, or computer web browser by following a link. HearChoice is designed to provide a step-by-step guide to decision-making about hearing healthcare, including background information about hearing loss, the importance of management, and guidance about options. HearChoice is presented using written text, images, interactive quizzes, and videos. HearChoice is designed so that participants can work through it at their own pace, and they may spend as little or long as they choose using HearChoice. Time spent on HearChoice will be monitored using website analytics. HearChoice will be made available to the participants for 3 months after they consent to participate, as we anticipate participants may wish to access the intervention more than once.
Intervention code [1] 328786 0
Behaviour
Comparator / control treatment
Hearing Loss Option Grid: hearing technology options. Participants will independently access the option grid via their smartphone, tablet, or computer web browser by following a link. The option grid is designed to provide a framework for decision-making about technology-based hearing management options, presented using written text. Participants will be allowed to review the option grid at their own pace, and they may spend as little or long as they choose using the option grid. Time spent on the option grid will be monitored using website analytics. The option grid will be made available to the participants for 3 months after they consent to participate, in line with what we plan to do for the HearChoice intervention.
Control group
Active

Outcomes
Primary outcome [1] 338496 0
Decisional conflict
Timepoint [1] 338496 0
Baseline, any time up to 5 days post intervention, 3 months post intervention. The primary timepoint is any time up to 5 days post intervention.
Secondary outcome [1] 436157 0
Preparedness for decision making
Timepoint [1] 436157 0
any time up to 5 days post intervention, 3 months post intervention
Secondary outcome [2] 436158 0
Readiness for hearing healthcare (readiness to take action)
Timepoint [2] 436158 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [3] 436159 0
Self-efficacy
Timepoint [3] 436159 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [4] 436160 0
Hearing-related quality of life
Timepoint [4] 436160 0
Baseline, 3 months post intervention.
Secondary outcome [5] 436166 0
Benefit: hearing aids or other devices - administered only to participants who obtained a hearing aid or other device
Timepoint [5] 436166 0
3 months post intervention
Secondary outcome [6] 436179 0
Economic benefit
Timepoint [6] 436179 0
Baseline, 3 months post intervention
Secondary outcome [7] 436181 0
Intervention evaluation
Timepoint [7] 436181 0
any time up to 5 days post intervention, 3 months post intervention
Secondary outcome [8] 436182 0
Use of online intervention
Timepoint [8] 436182 0
Any time intervention is accessed
Secondary outcome [9] 438845 0
Empowerment: knowledge, self-efficacy, skills, control, participation
Timepoint [9] 438845 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [10] 438846 0
Empowerment: knowledge
Timepoint [10] 438846 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [11] 438848 0
Empowerment: self-efficacy
Timepoint [11] 438848 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [12] 438849 0
Empowerment: skills
Timepoint [12] 438849 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [13] 438850 0
Empowerment: control
Timepoint [13] 438850 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [14] 438851 0
Empowerment: participation
Timepoint [14] 438851 0
Baseline, any time up to 5 days post intervention, 3 months post intervention.
Secondary outcome [15] 438853 0
Intention to take action
Timepoint [15] 438853 0
any time up to 5 days post intervention, 1 month post intervention, 3 months post intervention
Secondary outcome [16] 438854 0
Action taken
Timepoint [16] 438854 0
any time up to 5 days post intervention, 1 month post intervention, 3 months post intervention

Eligibility
Key inclusion criteria
=/>26 years of age
Currently residing in Australia
Subjective experience of hearing difficulty
English as a first spoken language or a good understanding of English
Access to computer, tablet or smartphone to navigate websites
Minimum age
26 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current user of hearing aid(s)

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 concealed via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using computerised sequence generation. Participants will be stratified according to age, perceived hearing difficulty, and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic and hearing characteristics of the intervention and control groups will be described at baseline.

Differences between groups will be evaluated at each timepoint using independent samples t-tests. The primary analysis will evaluate whether there is a difference between the intervention and control groups up to 5 days post intervention.

Analysis of variance will be used to compare change over time on each outcome measure between the intervention and control groups.

Additional analyses will be performed to explore the impact of demographic and hearing characteristics on each outcome over time between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
640
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316706 0
Government body
Name [1] 316706 0
National Health and Medical Research Council
Country [1] 316706 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 319398 0
None
Name [1] 319398 0
Address [1] 319398 0
Country [1] 319398 0
Other collaborator category [1] 283100 0
University
Name [1] 283100 0
University of Queensland
Address [1] 283100 0
Country [1] 283100 0
Australia
Other collaborator category [2] 283101 0
University
Name [2] 283101 0
Macquarie University
Address [2] 283101 0
Country [2] 283101 0
Australia
Other collaborator category [3] 283102 0
Government body
Name [3] 283102 0
National Acoustic Laboratories
Address [3] 283102 0
Country [3] 283102 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315484 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 315484 0
Ethics committee country [1] 315484 0
Australia
Date submitted for ethics approval [1] 315484 0
06/08/2024
Approval date [1] 315484 0
Ethics approval number [1] 315484 0

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

Contacts
Principal investigator
Name 134838 0
A/Prof Melanie Ferguson
Address 134838 0
enAble Institute, Curtin University, GPO Box U1987, Perth WA 6845, Australia
Country 134838 0
Australia
Phone 134838 0
+61 8 9266 3600
Fax 134838 0
Email 134838 0
[email protected]
Contact person for public queries
Name 134839 0
Melanie Ferguson
Address 134839 0
enAble Institute, Curtin University, GPO Box U1987, Perth WA 6845, Australia
Country 134839 0
Australia
Phone 134839 0
+61 8 9266 3600
Fax 134839 0
Email 134839 0
[email protected]
Contact person for scientific queries
Name 134840 0
Melanie Ferguson
Address 134840 0
enAble Institute, Curtin University, GPO Box U1987, Perth WA 6845, Australia
Country 134840 0
Australia
Phone 134840 0
+61 8 9266 3600
Fax 134840 0
Email 134840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified item-level data for demographic information and each outcome measure
When will data be available (start and end dates)?
Data will be made available upon completion of publication of the full program of research, and will be available for 5 years.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For any purpose for which the researchers have gained ethical approval
How or where can data be obtained?
Links to data will be published in peer-reviewed publications and on the ANZCTR.


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.