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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]

None

Universal Trial Number (UTN)

Trial acronym

HALOS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hearing Loss

Condition category

Condition code

Ear

Deafness

Ear

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [1]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [2]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [3]

Subjective hearing handicap as measured by the Hearing Handicap Inventory for Elderly Screening (Ventry, et al 1982).

Timepoint [3]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [4]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [5]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [6]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [7]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [8]

Self-reported number of falls in the last 12 months post-enrolment

Timepoint [8]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [9]

Frailty as measured using the FRAIL Scale (Woo et al 2012) which covers fatigue, resistance, ambulation, illness and loss of weight.

Timepoint [9]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [10]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [11]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [12]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [13]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [14]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [15]

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]

Once-off at the time of enrolment

Secondary outcome [16]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [17]

Psychomotor Function as measured by the Detection Task in the web-based, computerised Cogstate Brief Battery (Frederickson, et al 2010)

Timepoint [17]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [18]

Visual attention as measured by the Identification Task in the web-based computerised Cogstate Brief Battery (Frederickson, et al 2010)

Timepoint [18]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [19]

Working Memory as measured by the One-Back Task in the web-based, computerised Cogstate Brief Battery (Frederickson, et al 2010)

Timepoint [19]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [20]

Visual learning as measured by the One-Card Back Task in the web-based, computerised Cogstate Brief Battery (Frederickson, et al 2010)

Timepoint [20]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [21]

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]

Baseline, 2 years & 4 years post-enrolment

Secondary outcome [22]

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]

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?

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]

University

Name [1]

Macquaire University

Address [1]

Balaclava Rd
Macquarie Park
New South Wales 2109

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Cochlear Ltd

Address [2]

1 University Avenue
Macquarie University
New South Wales 2109

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Martin Lee Centre for Hearing Health Innovation

Address [3]

Balaclava Rd
Macquarie Park
New South Wales 2109

Country [3]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd
Macquarie Park
New South Wales 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee

Ethics committee address [1]

Balaclava Rd
North Ryde NSW  2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/05/2022

Approval date [1]

12/05/2022

Ethics approval number [1]

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

Prof Bamini Gopinath

Address

The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109

Country

Australia

Phone

+61 298508962

Fax

[email protected]

Contact person for public queries

Name

Jessica Turner

Address

Macquarie University Hearing
Department of Linguistics
Macquarie University
Balaclava Rd
Macquarie Park 2109

Country

Australia

Phone

+61 298508750

Fax

[email protected]

Contact person for scientific queries

Name

Bamini Gopinath

Address

The Australian Hearing Hub 16 University Avenue Macquarie University Macquarie Park NSW 2109

Country

Australia

Phone

+61 298508962

Fax

[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 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 ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
16009	Study protocol	[email protected]
16010	Informed consent form	[email protected]	384052-(Uploaded-20-05-2022-14-38-07)-Study-related document.pdf
16021	Ethical approval	[email protected]	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

Source	Title	Year of Publication	DOI
Embase	A protocol for the Hearing impairment in Adults: A Longitudinal Outcomes Study (HALOS).	2023	https://dx.doi.org/10.1371/journal.pone.0283171

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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