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Trial registered on ANZCTR


Registration number
ACTRN12622000752763
Ethics application status
Approved
Date submitted
16/05/2022
Date registered
26/05/2022
Date last updated
26/05/2022
Date data sharing statement initially provided
26/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Hearing impairment in Adults: a Longitudinal Outcomes Study (HALOS)
Scientific title
Hearing impairment in Adults: a Longitudinal Outcomes Study (HALOS)
Secondary ID [1] 307111 0
None
Universal Trial Number (UTN)
Trial acronym
HALOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 326272 0
Condition category
Condition code
Ear 323578 323578 0 0
Deafness
Ear 323579 323579 0 0
Other ear disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Hearing impairment in Adults: A Longitudinal Outcomes Study (HALOS) is a national, prospective, observational study on health and social outcomes from hearing device users (hearing aid & cochlear implant) aged 40 years and over.

The HALOS study will collect audiological, health, psychosocial, cognitive and functional outcomes that will be collected cross-sectionally and longitudinally. Participants will be surveyed at three time-points, (1) baseline, (2) 24-month follow-up, and (3) 48-month follow up. Participants will be required to fill out a 60-minute online survey using REDCap at each time-point which will assess the following outcomes:
1. Demographic, medical & treatment-related details
2. Health Utilities Index-3 (HUI-3)
3. Patient-Reported Outcomes Measurement Information System-43 (PROMIS-43)
4. Social Participation Restrictions Questionnaire (SPaRQ)
5. Hearing Handicap Inventory for Screening (HHIE-S)
6. Speech, Spatial & Qualities of Hearing Scale short form (SSQ-12)
7. International Outcome Inventory for Hearing Devices (IDI-HD)
8. Attitudes towards Loss of Hearing Questionnaire (ALHQ)
9. Illness Perception Questionnaire (IPQ)
10. Falls History
11. FRAIL Scale
12. Utrecht Work Engagement Scale (UWES-9)
13. Individual Work Performance Questionnaire
14. Quantitative Job Security
15. Short-Form Unmet Needs Survey (SF-SUNS)
16. Interpersonal Relationship Functioning

In addition to the survey, participants will complete a short 15 minute online computerised cognitive assessment using the Cogstate Brief Battery which includes 4 tests: Detection (rection time), identification test (choice reaction time), one card learning test (visual memory) and one back test (working memory). Participants will complete this unsupervised in their own homes.

Audiometric data will be obtained from hearing service providers for participants who have provided consent. The collected data will include audiometric thresholds for air and bone conduction stimuli in both ears for frequencies at 0.25 to 8.0 kHz and/or four-frequency average hearing loss (4FAHL) data. When the participant first presented to the clinic and type of amplification device used will also be collected.

A qualitative component will be conducted at baseline only in a subset of participants, in the form of semi-structured interviews conducted via telephone by a research assistant. This will investigate the experiences of the patient journey and the navigation of the hearing health service pathway. Participating in the interview is optional and the first 28 consenting participants (14 Hearing Aid and 14 Cochlear Implant users) will complete the interview.
Intervention code [1] 323568 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331343 0
Health-related quality of life (HRQoL) measured using the Health Utilities Index Mark 3 (HUI3) questionnaire (Horsman, et al 2003). HUI3 comprises of 8 dimensions including vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain.
Timepoint [1] 331343 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [1] 409578 0
Physical, mental, and social health of adults measured using the Patient Reported Outcome Measurement Information System - PROMIS-43 version 2.1 (Cell, et al 2019). Physical Health will be assessed from the physical function and fatigue domains. Mental Health will be assessed from the depression and anxiety domains. Social Health will be assessed from the ability to participate in social roles and activities domain.
Timepoint [1] 409578 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [2] 409579 0
Hearing-related participation restrictions as measured by the Social Participation Restrictions Questionnaire (Heffernan, et al, 2019), a hearing-specific patient reported outcome measure. The Social Behaviours subscale measures difficulties with performing actions in a social context due to hearing loss and the Social Perceptions subscale measured negative thoughts and feelings experienced in a social context due to hearing loss.
Timepoint [2] 409579 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [3] 409580 0
Subjective hearing handicap as measured by the Hearing Handicap Inventory for Elderly Screening (Ventry, et al 1982).
Timepoint [3] 409580 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [4] 409581 0
Hearing Disability across three domains, speech hearing, spatial hearing and qualities of hearing as measured by the Speech, Spatial & Qualities of Hearing Scale – 12 (Nobel et al, 2013).
Timepoint [4] 409581 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [5] 409582 0
The effectiveness of hearing devices as measured by a modified version of the International Outcome Inventory for Hearing Aids Questionnaire (Cox et al 2009). To include Cochlear Implant users, “hearing aid(s)” is replaced by “hearing device(s)” and is referred to as the International Outcome Inventory for Hearing Devices Questionnaire.
Timepoint [5] 409582 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [6] 409583 0
Attitudes towards hearing loss and hearing devices as measured using a modified version the Attitudes towards Loss of Hearing Questionnaire v2.1 (Saunders et al 2005). To include Cochlear Implant users, “hearing aid(s)” is replaced by “hearing device(s)”. Five domains are assessed: Denial of hearing loss, negative associations, negative coping strategies, manual dexterity and vision, and hearing-related esteem.
Timepoint [6] 409583 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [7] 409585 0
Illness perception as measured by the Brief Illness Perception Questionnaire (Broadbentet al 2006), which measures cognitive and emotional representations of illness. This has been modified for the context of hearing loss.
Timepoint [7] 409585 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [8] 409586 0
Self-reported number of falls in the last 12 months post-enrolment
Timepoint [8] 409586 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [9] 409587 0
Frailty as measured using the FRAIL Scale (Woo et al 2012) which covers fatigue, resistance, ambulation, illness and loss of weight.
Timepoint [9] 409587 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [10] 409588 0
Work engagement as measured using the Utrecht Work Engagement Scale 9 (Schaufeli, et al 2006), which evaluates work engagement based on three categories: vigour, dedication, and absorption. This will be completed only by participants who are currently working.
Timepoint [10] 409588 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [11] 409589 0
Job performance as measured using the Individual Work Performance Questionnaire (Ramos-Villagrass et al 2019), which evaluates the three main dimensions of job performance task performance, contextual performance, and counterproductive work behaviour. This will be completed only by participants who are currently working.
Timepoint [11] 409589 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [12] 409590 0
Job security as measured by three quantitative items from the Job Insecurity questionnaire (Hellgreen, et al, 1999). This will be completed only by participants who are currently working.
Timepoint [12] 409590 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [13] 409591 0
Unmet needs as measured by a modified version of the Short-Form Survivor Unmet Needs Survey (Campbell et al 2014), Four domains are assessed: information needs, work and financial needs, access and continuity of care and coping sharing and emotional needs. This questionnaire has been modified for hearing device users.
Timepoint [13] 409591 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [14] 409592 0
Interpersonal relationship functioning as measured by four items on topic avoidance from questions developed by Donvan-Kicken & Cauglin, 2010. This will be completed only be participants who identify as being currently in a relationship.
Timepoint [14] 409592 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [15] 409593 0
Qualitative data on the patient journey and navigation of the hearing health service pathway in a subsample of participants collected during a 30-minute semi-structured one-on-one telephone interview with a member of the research team.
Timepoint [15] 409593 0
Once-off at the time of enrolment
Secondary outcome [16] 409594 0
Cost-benefit analysis will be carried out from a societal perspective for a lifetime horizon to assess the intervention (cochlear implants and/or hearing aids) efficiency for hearing loss.
Timepoint [16] 409594 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [17] 409887 0
Psychomotor Function as measured by the Detection Task in the web-based, computerised Cogstate Brief Battery (Frederickson, et al 2010)
Timepoint [17] 409887 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [18] 409888 0
Visual attention as measured by the Identification Task in the web-based computerised Cogstate Brief Battery (Frederickson, et al 2010)
Timepoint [18] 409888 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [19] 409889 0
Working Memory as measured by the One-Back Task in the web-based, computerised Cogstate Brief Battery (Frederickson, et al 2010)
Timepoint [19] 409889 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [20] 409890 0
Visual learning as measured by the One-Card Back Task in the web-based, computerised Cogstate Brief Battery (Frederickson, et al 2010)
Timepoint [20] 409890 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [21] 409891 0
Psychomotor-attention composite score (Maruff, et al 2010) measured from aggregating performance on the Detection and Identification Tasks in the web-based computerised Cogstate Brief Battery (Frederickson, et al 2010)
Timepoint [21] 409891 0
Baseline, 2 years & 4 years post-enrolment
Secondary outcome [22] 409892 0
Learning - Working Memory composite score (Maruff, et al 2010) measured from aggregating performance on the One-Card Learning and One-Card back Tasks in the web-based computerised Cogstate Brief Battery (Frederickson, et al 2010)
Timepoint [22] 409892 0
Baseline, 2 years & 4 years post-enrolment

Eligibility
Key inclusion criteria
1. Aged 40+ years
2. Wears a hearing device (Hearing Aid and/or Cochlear Implant) in at least one ear
3. Able to give informed consent
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English language competency to complete the online survey

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size calculations were based a mixed model of repeated measures with a general correlation structure. The calculations assumed a group (CI versus HA) allocation ratio of 1:1, correlation between time points (rho) of 0.5, alpha of 0.05 and power of 0.8. Attrition rates (loss to follow-up) were estimated as 10% in the first follow-up and a further 20% for the last follow-up. Based upon available data from Contrera et al., 2016, using health-related quality of life as the outcome measure, a conservative effect size (Cohen’s d) ranging from 0.2 to 0.3 a minimum sample size of 206 to 454 per group (accounting for loss to follow-up) is needed to detect differences between the two groups in outcome of interest (i.e., quality of life) over time.

Descriptive statistics will be used to summarise the dataset and provide central tendency statistics. Regression models of repeated measures will be used to test for differences between and within the two groups over time. Interaction effects between the health outcomes will also be explored. To understand the complex relationships between treating hearing loss and health outcomes (e.g. quality of life, mental health status, and functioning) structural equation modelling and path analyses will be conducted to examine direct and indirect pathways. Patterns and trajectories and profiling developmental pathways for hearing impairment will be analysed with group-based trajectory modelling (GBTM). Using finite mixture modeling, GBTM maximizes information available in multivariate longitudinal data to track the course of an outcome and assess the heterogeneity in the population allowing for a more precise individual classifications into various groups that comprise of that taxonomy.

For the qualitative semi-structured interviews conducted at baseline, interviews will be transcribed verbatim and analysed using inductive thematic analysis. According to a recent qualitative study involving adults with a hearing loss, approximately 14 participants per group (cochlear implant & hearing aid users) will required to reach data saturation

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
908
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311416 0
University
Name [1] 311416 0
Macquaire University
Country [1] 311416 0
Australia
Funding source category [2] 311421 0
Commercial sector/Industry
Name [2] 311421 0
Cochlear Ltd
Country [2] 311421 0
Australia
Funding source category [3] 311422 0
Charities/Societies/Foundations
Name [3] 311422 0
Martin Lee Centre for Hearing Health Innovation
Country [3] 311422 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie Park
New South Wales 2109
Country
Australia
Secondary sponsor category [1] 312838 0
None
Name [1] 312838 0
Address [1] 312838 0
Country [1] 312838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310895 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 310895 0
Balaclava Rd
North Ryde NSW 2109
Ethics committee country [1] 310895 0
Australia
Date submitted for ethics approval [1] 310895 0
02/05/2022
Approval date [1] 310895 0
12/05/2022
Ethics approval number [1] 310895 0
11262

Summary
Brief summary
The objectives of HALOS is to:
1) evaluate the impacts of treating hearing loss on health (quality of life, cognition, depression/mood, functional status etc.), relationships, education, and work/employment outcomes.
2) examine differences in patterns/trajectories of long-term outcomes within and between groups [Hearing-aid (HA) versus Cochlear implant (CI)] of hearing device users.
3) determine the impact from the timing of intervention (initiation of HA use or implant of CI) and the effectiveness of earlier intervention on outcomes
4) evaluate the cost-effectiveness of early intervention/rehabilitation for hearing loss.

Adults aged 40 years and over who use either a Hearing Aid and/or Cochlear Implant will be recruited from participating hearing service providers and hearing loss support groups. Participants will complete an online survey and brief online cognitive assessment at three time-points, (1) baseline, (2) 24-month follow-up, and (3) 48-month follow up. Audiological, health, psychosocial, and functional outcomes will be measured using validated instruments. Audiometric data will be obtained from hearing service providers for participants who have provided consent. The collected data will include audiometric thresholds, information about when the participant first presented to the clinic and the type of amplification device used. Participants will also be invited to complete a semi-structured interview at baseline only which will investigate the experiences of the patient journey and the navigation of the hearing health service pathway.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119266 0
Prof Bamini Gopinath
Address 119266 0
The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109
Country 119266 0
Australia
Phone 119266 0
+61 298508962
Fax 119266 0
Email 119266 0
bamini.gopinath@mq.edu.au
Contact person for public queries
Name 119267 0
Mrs Jessica Turner
Address 119267 0
Macquarie University Hearing
Department of Linguistics
Macquarie University
Balaclava Rd
Macquarie Park 2109
Country 119267 0
Australia
Phone 119267 0
+61 298508750
Fax 119267 0
Email 119267 0
jessica.turner@mq.edu.au
Contact person for scientific queries
Name 119268 0
Prof Bamini Gopinath
Address 119268 0
The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109
Country 119268 0
Australia
Phone 119268 0
+61 298508962
Fax 119268 0
Email 119268 0
bamini.gopinath@mq.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 participant data collected during the trial.
When will data be available (start and end dates)?
Within 18 months of the completion of the project, with no end date.
Available to whom?
A case-by-case basis at the discretion of the Primary Investigator
Available for what types of analyses?
The analyses will be conducted to only achieve the aims of the project.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Bamini Gopinath (bamini.gopinath@sydney.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16009Study protocol  jessica.turner@mq.edu.au
16010Informed consent form  jessica.turner@mq.edu.au 384052-(Uploaded-20-05-2022-14-38-07)-Study-related document.pdf
16021Ethical approval  jessica.turner@mq.edu.au 384052-(Uploaded-20-05-2022-14-37-47)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA protocol for the Hearing impairment in Adults: A Longitudinal Outcomes Study (HALOS).2023https://dx.doi.org/10.1371/journal.pone.0283171
N.B. These documents automatically identified may not have been verified by the study sponsor.