Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000276651
Ethics application status
Approved
Date submitted
22/02/2023
Date registered
15/03/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
15/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of an online Hearing Wellbeing Program on wellbeing in adults with hearing conditions - a randomised clinical trial.
Scientific title
Implementation and Evaluation of a Co-Designed Program Targeting the Psychosocial and Emotional Impacts of Hearing Conditions in Adults
Secondary ID [1] 309054 0
None
Universal Trial Number (UTN)
Trial acronym
HWP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 329109 0
Mental health 329110 0
Condition category
Condition code
Ear 326082 326082 0 0
Deafness
Ear 326083 326083 0 0
Other ear disorders
Mental Health 326084 326084 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Hearing Wellbeing Program (HWP) is an online program that addresses the psychosocial and emotional needs of adults with hearing loss. An earlier co-design and feasibility study will first be conducted to develop and iterate the online HWP for use in the current study.

Once a participant registers for the online program, they will be prompted to complete a brief questionnaire that enables the content of the program to be tailored to the individual. Where a person indicates that they may be impacted within an area of psychosocial concern, the appropriate module is suggested. The HWP comprises 10 self-guided wellbeing modules:
1. Acceptance and hearing loss
2. Anxiety and hearing loss
3. Confidence, self-efficacy and hearing loss
4. Grief and hearing loss
5. Identity and hearing loss
6. Loneliness and hearing loss
7. Low mood and hearing loss
8. Relationships
9. Respectful communication and hearing loss
10. Stigma and hearing loss

Each module offers psychologically based information about the topic, followed by information about how this may relate to them as a person with a hearing condition. The modules use lay language and aim to validate the persons emotional and psychosocial experiences. This is enhanced via the inclusion of lived experience quotes and stories related to the topic.

Every module concludes with three or more psychologically based strategies and participants can choose the ones that feel most suitable for them. Each strategy is introduced and explained followed by an applied exercise or activity, as applicable. The program also indicates where support of a psychologist may be required. It is anticipated that the content will be delivered via a combination of written text, infographics, captioned short videos, and interactive components. It is anticipated that each module will take a minimum of 30 minutes to complete however this will vary depending upon the strategies and activities selected by each individual (with many strategies suitable for use on multiple occasions).

The program is completed securely online, and the participant can complete the program at a time and place of their choice, over a three month trial period. Learning Management System and web-based analytics will be used to monitor adherence and usage data. Self-reported engagement will be reported in a sub-set of participants invited to a semi-structured interview.
Intervention code [1] 325494 0
Treatment: Other
Intervention code [2] 325495 0
Rehabilitation
Intervention code [3] 325496 0
Behaviour
Comparator / control treatment
A short captioned video (10-15 minutes) that describes the social and emotional impacts of hearing conditions will be used as an active control. This information will be similar to the psychologically based information offered at the start of each of the HWP modules. Participants will have access to the video throughout the three month trial period and may watch it however many times they choose. The video will be developed specifically for the study.
Control group
Active

Outcomes
Primary outcome [1] 333948 0
Wellbeing (composite primary outcome consisting of social, emotional and psychological wellbeing) measured via mean score on the Mental Health Continuum-Short Form (MHC-SF)
Timepoint [1] 333948 0
Baseline
Post-intervention (immediately after 3 month trial period) - primary timepoint
3 months after trial period concluded (6 months from baseline)
Primary outcome [2] 333949 0
Wellbeing (composite primary outcome consisting of life satisfaction, acceptance of hearing loss, and social support) as measured via mean score on the Scale of the Subjective Well-Being of Older Adults with Hearing Loss (SWB-HL)
Timepoint [2] 333949 0
Baseline
Post-intervention (immediately after 3 month trial period) - primary timepoint
3 months after trial period concluded (6 months from baseline)
Primary outcome [3] 333950 0
Hearing handicap (composite primary outcome consisting of activity limitations and participation restrictions) as measured via mean score on the Revised Hearing Handicap Inventory (RHHI)
Timepoint [3] 333950 0
Baseline
Post-intervention (immediately after 3 month trial period) - primary timepoint
3 months after trial period concluded (6 months from baseline)
Secondary outcome [1] 418817 0
Health-related quality of life composite score measured via mean score on the 36-Item Short Form Survey (SF-36)
Timepoint [1] 418817 0
Baseline
Post-intervention (immediately after 3 month trial period)
3 months after trial period concluded (6 months from baseline)
Secondary outcome [2] 418818 0
Psychological symptoms (composite score and subscores for depression, anxiety and stress) as measured via mean score on the Depression, Anxiety, Stress Scale (DASS-21)
Timepoint [2] 418818 0
Baseline
Post-intervention (immediately after 3 month trial period)
3 months after trial period concluded (6 months from baseline)
Secondary outcome [3] 418820 0
Quality-adjusted life years (QALY) gained from each treatment will be determined via a composite health state index score that will be calculated from individual health profiles using the EQ-5D-5L and adjusted using the Australian value set published by Norman et al. (2023).

Norman, R., Mulhern, B., Lancsar, E. et al. The Use of a Discrete Choice Experiment Including Both Duration and Dead for the Development of an EQ-5D-5L Value Set for Australia. PharmacoEconomics (2023). https://doi.org/10.1007/s40273-023-01243-0
Timepoint [3] 418820 0
Baseline
Post-intervention (immediately after 3 month trial period)
3 months after trial period concluded (6 months from baseline)
Secondary outcome [4] 419143 0
Cost-utility analysis will provide an incremental cost effectiveness ratio (ICER) [net cost of intervention divided by net QALYs gained] that will be reported in monetary units (cost per QALY gained).

Cost of intervention will be calculated via audit of study specific financial records.
Timepoint [4] 419143 0
Baseline
Post-intervention (immediately after 3 month trial period)
3 months after trial period concluded (6 months from baseline)

Eligibility
Key inclusion criteria
Participants with self-reported hearing loss.
Access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central computerised concealed randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Upon registering for the study on the HWP webpage, participants will be randomised to the intervention or active control group using a computer-generated random number generator and redirected to the appropriate follow-on webpage.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A tentative a priori power analysis of the primary treatment outcome of wellbeing as measured by The Mental Health Continuum-Short Form (MHC-SF) suggested a total sample size of N=98 was required to detect a medium effect size (Cohen’s f = 0.25) at an alpha of 0.05 and power of 0.8 using between-subjects ANOVA. Sample size calculation will be reviewed following analysis of initial treatment data obtained in an initial feasibility study.

Descriptive statistics will summarise the profile of study participants. These will be presented as frequencies and percentages for categorical variables; means, standard deviations, medians and ranges for variables measured on a continuous scale. Quantitative efficacy data will be analysed using an intention to treat analysis and linear mixed model approaches to determine indicators of reliable clinical change and the effect sizes in change in wellbeing pre- and post-intervention, and differences between intervention and control groups. Multivariate multiple linear regression will be conducted to explore possible impact of demographic characteristics and recruitment pathways on the efficacy of the intervention.

A process evaluation will be conducted using content analysis from qualitative interviews conducted with a subsample of participants and user experience questionnaires. The purpose of the process evaluation is to increase understanding of the HWP intervention by evaluating aspects of implementation, mechanisms of impact, and the context in which the HWP is delivered. Program analytic data will be analysed against the efficacy data to understand the mechanisms of action of the program with respect to dose, reach and type of module. A cost-analysis will be undertaken using the EQ-5D-5L data combined with program analytics and willingness to pay data from an initial feasibility study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
6/01/2025
Actual
Date of last data collection
Anticipated
10/11/2025
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313257 0
Government body
Name [1] 313257 0
National Health and Medical Research Council (NHMRC)
Country [1] 313257 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Soundfair Australia
Address
Soundfair Australia
1 Hamilton Place
Mount Waverley VIC 3149
Country
Australia
Secondary sponsor category [1] 314999 0
None
Name [1] 314999 0
Address [1] 314999 0
Country [1] 314999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312489 0
University of Melbourne HREC (Greater than low risk - Science, Technology, Engineering, Mathematics and Medicine (STEMM))
Ethics committee address [1] 312489 0
The University of Melbourne
Grattan Street
Parkville VIC 3010
Ethics committee country [1] 312489 0
Australia
Date submitted for ethics approval [1] 312489 0
24/03/2023
Approval date [1] 312489 0
29/05/2023
Ethics approval number [1] 312489 0
2023-25812-40874-3

Summary
Brief summary
The overall aim of this project is to adapt an existing Hearing Wellbeing Program (HWP) to be an implementation-ready online intervention that addresses the psychosocial and emotional needs of adults with hearing loss. The HWP is the output of a human-centred co-design process conducted in 2020-21 with people living with hearing loss, researchers, audiologists, and psychologists, policy makers, philanthropic organisations, and consultants, initiated by Soundfair (a consumer-driven charity) to address a gap in offerings that address the psychosocial and emotional impacts of hearing loss. It comprises 10 self-guided wellbeing modules, currently available only in hard copy. It is, however, ideally suited to adaptation as an online resource, thus allowing flexibility in its delivery in response to consumers’ desire for accessible support options that are not tied to specific help-seeking pathways (i.e., seeing a hearing healthcare professional) nor location or geography.
Specifically, this project will:
1. Adapt the existing HWP to be self-paced and online, using co-design methods with adults with lived experience of hearing loss, audiologists, psychologists, and digital technology experts.
2. Assess and determine the feasibility of the online HWP, and revise the program based on these results.
3. To evaluate the efficacy and health costs of the online HWP for adults with hearing loss, compared to an active control, in a clinical trial.
Trial website
Trial related presentations / publications
Public notes
This project will have three phases:
1. Focus groups and workshops to convert the Hearing Wellbeing Program into an online program. Estimated March-November 2023.
2. A feasibility study to explore the Hearing Wellbeing Program in a small group of users. Estimated November 2023 - July 2024.
3. A clinical trial to determine the effect of the Hearing Wellbeing Program. Estimated August 2024 - September 2025.

Contacts
Principal investigator
Name 124842 0
Dr Emma Laird
Address 124842 0
Soundfair Australia
1 Hamilton Place
Mount Waverley VIC 3149
Country 124842 0
Australia
Phone 124842 0
+61 03 9510 1577
Fax 124842 0
+61 03 8640 0681
Email 124842 0
emma@soundfair.org.au
Contact person for public queries
Name 124843 0
Dr Emma Laird
Address 124843 0
Soundfair Australia
1 Hamilton Place
Mount Waverley VIC 3149
Country 124843 0
Australia
Phone 124843 0
+61 03 9510 1577
Fax 124843 0
+61 03 8640 0681
Email 124843 0
emma@soundfair.org.au
Contact person for scientific queries
Name 124844 0
Dr Emma Laird
Address 124844 0
Department of Audiology and Speech Pathology
The University of Melbourne
550 Swanston Street
Carlton VIC 3053
Country 124844 0
Australia
Phone 124844 0
+61 03 8344 2501
Fax 124844 0
Email 124844 0
emma.laird@unimelb.edu.au

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 individual line-by-line data of quantitative outcomes.
When will data be available (start and end dates)?
Immediately following all publication outputs. No end date determined.
Available to whom?
Researchers who provide a sound proposal.
Available for what types of analyses?
IPD meta-analyses.
How or where can data be obtained?
Please contact principal investigator via email on emma@soundfair.org.au or emma.laird@unimelb.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18408Study protocol  emma@soundfair.org.au
18409Informed consent form  emma@soundfair.org.au
18410Statistical analysis plan  emma@soundfair.org.au
18411Ethical approval  emma@soundfair.org.au
18412Other  emma@soundfair.org.au Participant recruitment advertisement



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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