Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000277640
Ethics application status
Approved
Date submitted
2/03/2023
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 implementation of an online Hearing Wellbeing Program on wellbeing in adults with hearing conditions - co-design development and feasibility study.
Scientific title
Development and Feasibility of a Co-Designed Program Targeting the Psychosocial and Emotional Impacts of Hearing Conditions in Adults
Secondary ID [1] 309114 0
None
Universal Trial Number (UTN)
Trial acronym
HWP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 329203 0
Mental health 329204 0
Condition category
Condition code
Ear 326162 326162 0 0
Deafness
Ear 326163 326163 0 0
Other ear disorders
Mental Health 326164 326164 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The existing Hearing Wellbeing Program (HWP) is an intervention that addresses the psychosocial and emotional needs of adults with hearing loss. It comprises 10 self-guided wellbeing modules, currently available only in hard copy (further information provided below). The first phase of the research will adapt the existing HWP to be self-paced and online, using co-design methods with adults with lived experience of hearing loss, audiologists, psychologists, educationalists, and digital technology experts.

Co-design participants will first attend an online workshop for a duration of approximately 2-3 hours to formulate a plan and structure for the online version of the HWP. Following this development, a prototype of the online HWP will be created. Approximately three months later, participants will attend another online workshop for a duration of approximately 1-2 hours to test the prototype of the online HWP and provide feedback for further changes. Iterative versions of the HWP will then be asynchronously tested by co-design participants. An email link to the updated HWP will be provided for each iteration and feedback will be requested via return email. The online HWP will be deemed ready to be piloted in the feasibility study when there are no more significant issues or changes required.

Participants will then be recruited for the feasibility 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. A sub-set of participants will be invited to a semi-structured interview to explore usability, understandability, ease of use, burden, recommendation, and willingness to pay. The participants invited to the interview will be purposively sampled based on engagement with the program and demographic variables to obtain a wide range of perspectives. Online interviews will be conducted within 1-2 months of trial completion.
Intervention code [1] 325560 0
Treatment: Other
Intervention code [2] 325561 0
Rehabilitation
Intervention code [3] 325562 0
Behaviour
Comparator / control treatment
None. Single-arm, pre-post feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334034 0
Deductive thematic analysis of themes generated from semi-structured interviews using the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) in the subset of participants invited for the interview post-intervention.
Timepoint [1] 334034 0
Post-intervention (immediately after 3 month study period)
Primary outcome [2] 334035 0
Primary composite outcome: Feasibility of the study design for a subsequent randomised controlled trial (RCT). Dichotomous outcome:
a) Composite of process outcomes indicates that the study design is feasible for subsequent RCT.
b) Composite of process outcomes indicates that the study design is not suitable to RCT in current iteration.

The following process outcomes will contribute to composite feasibility outcome:
1. Recruitment rate determined from study records
2. Sample characteristics as determined from demographic questionnaire
3. Resource use as determined from study records
4. Ability to manage study as determined from study records
5. Intervention use and compliance as determined from web analytics
Timepoint [2] 334035 0
Post-intervention (immediately after 3 month study period) - primary timepoint
Primary outcome [3] 334036 0
Digital intervention usability as measured by the mean score of the System Usability Scale (SUS)
Timepoint [3] 334036 0
Post-intervention (immediately after 3 month study period) - primary timepoint
Secondary outcome [1] 419144 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 [1] 419144 0
Baseline
Post-intervention (immediately after 3 month study period)
Secondary outcome [2] 419145 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 [2] 419145 0
Baseline
Post-intervention (immediately after 3 month study period)
Secondary outcome [3] 419146 0
Health-related quality of life composite score measured via mean score on the 36-Item Short Form Survey (SF-36)
Timepoint [3] 419146 0
Baseline
Post-intervention (immediately after 3 month study period)
Secondary outcome [4] 419147 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 [4] 419147 0
Baseline
Post-intervention (immediately after 3 month study period)
Secondary outcome [5] 419385 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 [5] 419385 0
Baseline
Post-intervention (immediately after 3 month study period)
Secondary outcome [6] 419386 0
Acceptability of the online HWP as measured by the mean score of the Acceptability of Intervention Measure (AIM)
Timepoint [6] 419386 0
Post-intervention (immediately after 3 month study period)
Secondary outcome [7] 419387 0
Appropriateness of the online HWP as measured by the mean score on the Intervention Appropriateness Measure (IAM)
Timepoint [7] 419387 0
Post-intervention (immediately after 3 month study period)
Secondary outcome [8] 419390 0
Engagement with the HWP as measured via the mean score of the User Engagement Scale Short Form (UES-SF)
Timepoint [8] 419390 0
Post-intervention (immediately after 3 month study period)

Eligibility
Key inclusion criteria
Co-design participant key inclusion criteria: Participants with self-reported hearing loss, audiologists, psychologists, educationalists and digital technology experts.
Access to the internet.

Feasibility study participant 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Part 1: A qualitative co-design approach will be utilised across two workshops to adapt the HWP to an online version given that stakeholder inclusion can increase acceptability and future effectiveness of healthcare interventions. Workshop 1 will be used to create and refine the structure of the online HWP by bringing together a co-design team including people with lived experience, educationalists, technology experts, and healthcare providers. In Workshop 2, a prototype will be presented to the group for user testing, feedback, and iteration. The online HWP will be further iterated in partnership with the co-design team and research steering committee.

Part 2: A feasibility study will then assess and determine the feasibility of the online HWP, with results guiding further revision of the program. The feasibility study will employ a mixed-methods, single-arm, pre-post intervention design.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Part 1: Workshops will be recorded and transcribed verbatum. Data will be analysed using deductive qualitative thematic analysis, guided by the RE-AIM framework. We aim to recruit up to 10 participants to be involved in the co-design portion.

Part 2: Interview data will be analysed using qualitative descriptive content analysis to gain an in-depth understanding of the experiences of both participants who found the program acceptable and useful and those whose experience was less positive. Quantitative data will be analysed using descriptive statistics given the small sample of the study and will inform refinement of the randomised-controlled trial protocol. We aim to recruit approximately 30 participants for the feasibility study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
5/07/2023
Date of last participant enrolment
Anticipated
15/03/2024
Actual
Date of last data collection
Anticipated
6/05/2024
Actual
Sample size
Target
45
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313315 0
Government body
Name [1] 313315 0
National Health and Medical Research Council (NHMRC)
Country [1] 313315 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] 315060 0
None
Name [1] 315060 0
Address [1] 315060 0
Country [1] 315060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312541 0
University of Melbourne HREC (Greater than low risk - Science, Technology, Engineering, Mathematics and Medicine (STEMM))
Ethics committee address [1] 312541 0
Ethics committee country [1] 312541 0
Australia
Date submitted for ethics approval [1] 312541 0
24/03/2023
Approval date [1] 312541 0
29/05/2023
Ethics approval number [1] 312541 0
2023-25812-40874-3

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

Contacts
Principal investigator
Name 125026 0
Dr Emma Laird
Address 125026 0
Soundfair Australia
1 Hamilton Place
Mount Waverley VIC 3149
Country 125026 0
Australia
Phone 125026 0
+61 03 9510 1577
Fax 125026 0
+61 03 8640 0681
Email 125026 0
[email protected]
Contact person for public queries
Name 125027 0
Emma Laird
Address 125027 0
Soundfair Australia
1 Hamilton Place
Mount Waverley VIC 3149
Country 125027 0
Australia
Phone 125027 0
+61 03 9510 1577
Fax 125027 0
+61 03 8640 0681
Email 125027 0
[email protected]
Contact person for scientific queries
Name 125028 0
Emma Laird
Address 125028 0
Department of Audiology and Speech Pathology
The University of Melbourne
550 Swanston Street
Carlton VIC 3053
Country 125028 0
Australia
Phone 125028 0
+61 03 8344 2501
Fax 125028 0
Email 125028 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
Given the nature of this part of the study (workshops and qualitative interviews throughout co-design process and small sample size feasibility study) individual participant data will not be available to protect participant anonymity. Individual participant data will be available in the final part of the project (clinical trial).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18468Study protocol  [email protected]
18469Informed consent form  [email protected]
18470Ethical approval  [email protected]
18471Statistical analysis plan  [email protected]
18472Other  [email protected] Participant recruitment advertisement



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.