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Trial registered on ANZCTR


Registration number
ACTRN12619000286145
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
25/02/2019
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Date results provided
25/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Teleaudiology hearing aid fitting follow-up consultations for adults
Scientific title
Teleaudiology hearing aid fitting follow-up consultations for adults: an evaluation of a translational study through a single-blinded randomized controlled trial and mini-cohort
Secondary ID [1] 296950 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing impairment 310907 0
Condition category
Condition code
Ear 309575 309575 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of interventions below are following the TIDieR checklist as recommended.
1. Brief name: Standard face-to-face and teleaudiology (remote) hearing aid fitting follow-up consultations were delivered for adults (new and experienced hearing aid users)
2. Why: Hearing loss is the fourth leading cause of years lived with disability. There is currently over 466 million people with disabling hearing loss across the globe. This number is expected to double by 2050. One of the main barriers to deliver timely services to these people is related to the imbalance between supply and demand in terms of number of patients versus hearing professionals, and their disproportional geographical distribution. The physical as well as economic barriers make difficult for patients to reach a clinic. Consultations at a distance (teleaudiology) would help to improve access to hearing services and reduce the global burden of unaddressed hearing loss. Rehabilitation with hearing aids fitting is the primary intervention for disabling hearing loss. Follow-up hearing aid fitting consultations are the most demading and necessary type of appointment after hearing aid fitting due to the complexity of adjusting the hearing aids to the patients' individual needs and ensure the delivery of the optimum benefit, satisfaction and handicap reduction for patients, which can reflect on their quality of life.
3. Materials: Two laptop computers with Microsoft Windows 10 operating system and two ‘dongles’ to provide 4G mobile internet connectivity were used for remote consultations. Both laptops had the same configurations and replicated the standard audiology computer system including software packages: (a) Noah (HIMSA, Copenhagen, Denmark) with Phonak and Unitron fitting software (Sonova Group, Stäfa, Switzerland) to programme hearing aids, and (b) TeamViewer Business (Goppingen, Germany) to enable the facilitator’s laptop to be controlled by the audiologist’s laptop and video-conferencing between the two sites. A portable bluetooth speaker on the remote site was used to provide better sound than the laptop speaker, and the audiologist used a headset. The laptops microphones used. The facilitator assisting the audiologist and patient on the remote site was also equipped with hearing aid accessories (e.g. otoscope, domes, cerustops, magnets, rotary tool for drilling and griding, cleaning kit, receivers, slim tubes, etc.), and paper copies of the study surveys that needed to be applied straight after the consultation.
4. Procedures: Participants received the fitting of hearing aids in the clinic as standard routine practice. Their care was continued as part of this study by another audiologist. The consistency of the clinical procedures were maintained in both teleaudiology and conventional follow-up consultations in which interventions were focused on the needs of each patient (patient-centred service). After greeting the patient, the audiologist (i) enquired whether there was any improvement in communication difficulties reported prior HA fitting, (ii) identified and/or assessed fitting issues or needs related to physical comfort, sound parameters or ease of management, (iii) addressed the (new) issues (if any) that patient could have been experiencing (e.g. “echoey” speech sound) and/or the audiologist could have identified (e.g. difficulty in correctly positioning the ear piece in the ear canal) through fine-tuning, counselling (including communication strategies) and instructions (including demonstrations and testing, e.g. phone use), (iv) addressed any further questions or doubts the participant and/or his/her significant other person had, (v) informed the patient on what the next step was and what he/she or the audiologist would expect for the next period until the next appointment, and (vi) made sure that all was clear for the patient, that they were happy with apparent result, and then finalized the consultation.
5. Who provided: All the follow-up consultations were provided by the same certified and licensed audiologist with 15 years of clinical experience to control for clinican's expertise. The remote consultations were delivered with the assistance of a facilitator who acted as the audiologist's hands on the remote side to help the audiologist and the patient. To control for the level of experience in assisting the audiologist and patient during the remote consultations, four volunteers in the first year of a Masters in Audiology course, who had basic HAs knowledge but as yet no practical experience acted as the facilitators. Prior to the start of the study, they received face-to-face training on the technical and clinical tasks that they would be required to undertake.
6. How, and 7. where: Two groups with participants randomized for their experience with hearing aids were recruited. Participants in each group received one standard face-to-face and one teleaudiology follow-up consultation in opposite order for first and second consultation. Group 1 (G1) received their first follow-up consultation face-to-face and their second consultation remotely. Group 2 (G2) received their follow-up consultations in the other order, first remotely and secondly face-to-face. Face-to-face consultations were delivered at the clinic as per conventional practice and remote consultations were delivered at the participants' most convenient places (e.g. home, office, clinic) through synchronous (real time video-conference) teleaudiology. The audiologist remotely controlled the fitting software installed in the remote computer and the hearing aids were wiressly programmed through the use of a wireless programming interface (iCube II or Noahlink). During remote consultations, if on occasions the internet connection or transmission of data was poor such that it compromised the communication, a telephone call using the speaker-phone facility was used. Each participant was seen three times by the research audiologist: two follow-up consultations and a third consultation for assessment of outcomes. Service was provided for participants who needed further intervention at this final consultation after the end of the study.
8. When and how much: The study was controlled for the number of interventions. Two follow-up consultations were delivered for each participant and participants did not receive any extra consutlations or any other clinical assistance between consultations, at the clinic in-person or by phone or email, during the study. In addition, the intervals between consultations were controlled through coordination of the availability of participants, facilitators and audiologist, as well as re-bookings resulting from unexpected issues (e.g. sickness), to ensure that intervals were in most cases between 7 to 14 days and thereby, reflecting as closely as possible standard clinical practice for the timing of follow-up consultations. The duration of the consultations was registered and was supposed to be delivered within approximately 45 minutes as per normal clinic routine.
9. and 10. Tailoring and modifications: This study presents a methodology that was incorporated into routine clinical practice of three audiology clinics (Lions Hearing Clinics) in southern, eastern and northern urbans area of Perth, Western Australia. There was minimal disruption to routine clinical practice in relation to the bookings and occasional re-bookings of appointments for the study. Consultations only differed from each other on the mode of delivery. All the clinical procedures (physical and sensory management, instructions and counselling) involved in the HA fitting and follow-up consultations were delivered as they are normally in conventional clinical routine.Ear impressions and real ear measurements (REMs) were not performed in the follow-up consultations due to the need of expensive equipment to be on the remote side and because it is rarely used in follow-up hearing aid fitting consultations. Hearing aid adjustments were based on the REM traces resulted from the fitting consultation and on the fitting needs reported by the participants or identified by the audiologist. Clinical best practices were required to be followed in the clinics from where the participants were recruited and these continued in the care provided as part of this study, as described in the procedures above.
11. and 12. The outcome assessor was the audiologist as it usually is in routine practice. The audiologist who delivered the follow-up consultations made use of a checklist regarding the application of the tools for each participant’s face-to-face and remote consultations for consistency of clinical and research procedures.
Intervention code [1] 313220 0
Rehabilitation
Comparator / control treatment
The control was a group of participants who received gold standard consultations (face-to-face) and the experimental was a group of participants who received teleaudiology consultations (remote).
Control group
Active

Outcomes
Primary outcome [1] 318528 0
Primary outcome 1: mean/median COSI score (Client Oriented Scale of Improvement, a validated tool with Likert scale 5 point) by measurement of improvement (change) of communication with interventions.
Timepoint [1] 318528 0
Identification of communication situations (goals) at the hearing aid fitting consultation and measurements were immediately prior interventions in each of the next consultations (two follow-up consultations and one outcome assessment consultation).
Primary outcome [2] 318529 0
Primary Outcome 2: mean/median HAII score (Hearing Aid Issues Instrument, a designed tool in absence of an available tool; Likert scale 7 point) by measurement of improvement (change) of fitting issues with interventions.
Timepoint [2] 318529 0
Identification of fitting issues was done immediately prior the first follow-up consultation and addressed during this consultation. Measurements were at immediately prior each next intervention (in the next consultation).
Primary outcome [3] 318530 0
Primary Outcome 3: mean/median IOI-HA score (International Outcome Inventory for Hearing Aids, a validated tool with Likert scale 5 point) by measurement of improvement (changes) of quality of life aspects and overall quality of life.
Timepoint [3] 318530 0
As per original tool, items were applied at the end of the study (Outcome assessment consultation). Some of the items were slightly changed to allow investigation of before-after comparisons.
Secondary outcome [1] 365286 0
Participants' satisfaction with each consultation was measured by the HASS-P (Hearing aid Service Satisfaction for Patients/Participants) using a 5 point Likert scale. This tool was designed for the study in absence of an available tool. Mean/median scores were evaluated.
Timepoint [1] 365286 0
The HASS-P was applied straight after the consultations.

Secondary outcome [2] 365287 0
Participants' satisfaction regarding the service received was measured by the HAUQ (Hearing Aid Users Questionnaire, a validated tool) items #6 and 7 using a 5 pont Likert scale, and items #9 to 11 using open-ended questions.
Timepoint [2] 365287 0
Applied at the end of the study in the Outcome assessment consultation.
Secondary outcome [3] 365288 0
Audiologist' satisfaction with each consultation was measured by HASS-A (Hearing Aid Service Satisfaction for Audiologists) using a 5 point Likert scale. This tool was designed for the study in absence of an available tool. Mean/median scores were evaluated. It was used to investigate the quality of the service provided from professional's perspective and also barriers (technical and human-related) to satisfaction with the services provided.
Timepoint [3] 365288 0
The HASS-A was applied straight after the consultations.
Secondary outcome [4] 367326 0
Yes/No single question was applied to investigate whether the participants believed that remote consultations can similarly address their needs compared to face-to-face consultations.
Timepoint [4] 367326 0
Applied at the end of the sutdy in the Outcome assessment consultation.
Secondary outcome [5] 367327 0
Remaining pre-established hearing aid fitting issues were investigated by HAUQ item #4 (Yes/No answers).
Timepoint [5] 367327 0
Applied at the end of the sutdy in the Outcome assessment consultation.
Secondary outcome [6] 367328 0
Daily hours of hearing aid use was investigated by IOI-HA item#1 and HAUQ item #2.
Timepoint [6] 367328 0
Applied at the end of the sutdy in the Outcome assessment consultation.
Secondary outcome [7] 367329 0
Participants' self-perceived need for further consultation was investigated by HAUQ item #8 (Yes/No answer).
Timepoint [7] 367329 0
Applied at the end of the sutdy in the Outcome assessment consultation.
Secondary outcome [8] 367330 0
Participants' satisfaction with the hearing aid after treatment was measured by IOI-HA item #4 and HAUQ item #5.
Timepoint [8] 367330 0
Applied at the end of the sutdy in the Outcome assessment consultation.
Secondary outcome [9] 367334 0
Barriers (technical and human-related) to participants' satisfaction with the services provided were investigated by HASS-P through closed questions for each aspect of the service asking it their satisfaction was affected by any human- or technical-related issues during the provision of the service. Answers were open.
Timepoint [9] 367334 0
The HASS-P was applied straight after the consultations.
Secondary outcome [10] 367378 0
Duration of the consultations will be measured by registering the amount of time taken for the delivery of each standard face-to-face and teleaudiology consultation.
Timepoint [10] 367378 0
Applied for each consultation.

Eligibility
Key inclusion criteria
The inclusion and exclusion criteria for participation were designed to include people who are typically seen in hearing aid clinics. Inclusion criteria: (i) new HA users who were to be fitted with HAs for the first time, (ii) experienced HA users (with at least 1 year of HA use) to be fitted with a different set of aids compared to those previously worn, (iii) were over 18 years of age, (iv) could speak fluent English, and (v) were in good general health. All types, severities and configurations of hearing loss were accepted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who were in a dependent relationship that precluded them from making independent decision, or unable to perform tasks required due to an underlying physical or mental condition (e.g. difficulty to recall information, unable to provide answers to questions, move arms and hands, presented with visual severe impairment, etc.) were not included.

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)
The allocation was concealed from those recruiting participants until the moment of assignment by contacting the holder of the allocation schedule who was 'off-site' or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified randomisation was used to counterbalance the level of experience with HA that could influence treatment responsiveness. A sequence of nominal identification numbers was generated in Microsoft Excel. This was used to allocate 56 participants into groups “1” and “2”, with an equal number of new (n = 14) and experienced (n = 14) HA users in each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
This study design allowed a parallel assingment for cross-sectional comparisons (type effect) as well as it allowed two prospective mini-cohorts with a crossover assingment for each group (consultations delivered in opposite order in each group) for longitudinal comparisons (pre-post or before-after effect). This allowed analysis of the order effect.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A change of at least 0.55 in the COSI or HAII mean scores of participants was considered a clinically important difference. The basis for this was that the minimum difference reflects a certainty of significant clinical change pre-post intervention(s) from at least one ordinal response to another (e.g. from ‘somewhat better’ to ‘better’) for at least one of the communication or fitting situations from which mean scores were obtained from averaging scores across situations within participants. In case one cancels each other out (e.g. one goes up by one step, and another down by one step) there will not be a significant clinical change, and this indicates that the intervention is not yet effective. For 80% chance to detect a difference of at least 0.55 between average scores within participants from baseline (before follow-up interventions) to the end of the assessment period and between participants in the control and experimental groups, and assuming a standard deviation (SD) of 0.64 (same as for COSI, Dillon, James and Ginis, 1997), a sample of 14 participants in each group was needed for recruitment for comparisons between related observations and 25 participants in each group for comparisons between independent observations (two-tailed a = 0.05).

Likert scales were most often used for participants’ assessment (IOI_HA, COSI, HAII, HASS P/A and some items from the HAUQ). These were treated as ordinal and/or scale variables when scores were averaged within or across participants.
Normality of data distribution was assessed by Shapiro-Wilk test. When data was not normally distributed (also after attempts to transform the data), non-parametric tests were employed using the SPSS statistical package software.
The Kruskal-Wallis H test, a rank-based test, was used to determine whether there were any statistical differences between responses of independent observations (different participants in each group) of two or more groups. The Wilcoxon signed-rank test was used to determine whether there were any statistical differences between responses of two related groups (same participants in both groups) whereas the Friedman test was used for three or more related groups. These tests were used to examine the difference in the distribution of scores, medians and/or mean-ranks of two groups, which measures the effect of a condition on the location of the distribution regarding the outcome of interest. A post-hoc test with Bonferroni correction to the alpha values was run for determining where the significant differences were; this performs multiple pairwise comparisons when testing more than two groups (e.g. subgroups, new and experience users) and controlling for Type I errors.
Effect size estimates were calculated and assessed against Cohen's criteria (0.1 = small, 0.3 = medium, 0.5 = large effect). Power of statistical analysis were also calculated using the G*Power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/09/2016
Date of last participant enrolment
Anticipated
Actual
3/11/2017
Date of last data collection
Anticipated
Actual
7/12/2018
Sample size
Target
56
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12800 0
Lions Hearing Clinic - Joondalup - Joondalup
Recruitment hospital [2] 12801 0
Lions Hearing Clinic - Mount Lawley - Mount Lawley
Recruitment hospital [3] 12802 0
Lions Hearing Clinic - Winthrop - Winthrop
Recruitment postcode(s) [1] 25272 0
6027 - Joondalup
Recruitment postcode(s) [2] 25273 0
6050 - Mount Lawley
Recruitment postcode(s) [3] 25274 0
6150 - Winthrop

Funding & Sponsors
Funding source category [1] 301519 0
Government body
Name [1] 301519 0
Coordination for the Improvement of Higher Education Personnel (CAPES) Foundation, Ministry of Education
Country [1] 301519 0
Brazil
Funding source category [2] 301520 0
Other
Name [2] 301520 0
Ear Science Institute Australia
Country [2] 301520 0
Australia
Primary sponsor type
Other
Name
Ear Science Institute Australia
Address
1 Salvado Road, Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 301758 0
None
Name [1] 301758 0
Address [1] 301758 0
Country [1] 301758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302262 0
Human Ethics Office of Research Enterprise
Ethics committee address [1] 302262 0
Ethics committee country [1] 302262 0
Australia
Date submitted for ethics approval [1] 302262 0
11/09/2015
Approval date [1] 302262 0
14/10/2015
Ethics approval number [1] 302262 0
RA/4/1/7819

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

Contacts
Principal investigator
Name 89614 0
Mrs Karina Ferreira Mello Tao
Address 89614 0
Ear Science Institute Australia
1 Salvado Road, Subiaco, WA 6008
Country 89614 0
Australia
Phone 89614 0
+61 8 63804900
Fax 89614 0
Email 89614 0
[email protected]
Contact person for public queries
Name 89615 0
Robert Eikelboom
Address 89615 0
Ear Science Institute Australia
1 Salvado Road, Subiaco, WA 6008
Country 89615 0
Australia
Phone 89615 0
+61 8 63804900
Fax 89615 0
Email 89615 0
[email protected]
Contact person for scientific queries
Name 89616 0
Robert Eikelboom
Address 89616 0
Ear Science Institute Australia
1 Salvado Road, Subiaco, WA 6008
Country 89616 0
Australia
Phone 89616 0
+61 8 63804900
Fax 89616 0
Email 89616 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
IPD will not be shared because of confidentiality of personal clinical data; furthermore consent to release data was not requested. In a study of this nature and with this relatively small sample size, anonymising data is very difficult.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1272Informed consent form    376639-(Uploaded-01-02-2019-15-12-48)-Study-related document.pdf
1273Ethical approval    376639-(Uploaded-01-02-2019-15-14-52)-Study-related document.pdf
1274Ethical approval    Ammendments approval 376639-(Uploaded-01-02-2019-15-15-46)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.