ClinicalTrials.gg
Enrolling by invitationNCT04673565MI-HATUpdated May 7, 2026

Motivational Interviewing in Hearing Aid Users

An interventional study of Motivational interviewing in Hearing Loss, Motivation and Hearing Disability, sponsored by University of British Columbia. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Primary conditionDeafnessRegistry: Hearing LossReclassifiedWhy we changed it
Registry
Hearing Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Deafness
Why
  1. The study's listed conditions name Deafness, a narrower term within Hearing Loss.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Hearing loss is one of the most common chronic disabilities in the older adult population and affects their quality of life. Hearing aid use can improve one's quality of life by increasing a person's ability to detect, differentiate and locate sound, and improve speech recognition. Several factors seem to reduce motivation to use a hearing aid. Fears of exclusion and shame due to hearing loss are major deterrents to hearing aid use. Motivational interviewing (MI) is a counselling style aimed at creating desire in patients to change their behavior.

There have been pilot studies that suggest one-on-one MI can increase hearing aid use, but other pilot studies found the reverse hence the evidence is inconclusive. The effectiveness of group MI therapy is also being investigated in MI research. While results in group MI research are promising, studies investigating group MI have been limited to substance abuse.

Read the detailed description

Hearing loss is one of the most common chronic disabilities in the older adult population and affects their quality of life. Hearing aid use can improve one's quality of life by increasing a person's ability to detect, differentiate and locate sound, and improve speech recognition. Several factors seem to reduce motivation to use a hearing aid. Fears of exclusion and shame due to hearing loss are major deterrents to hearing aid use. MI is a counselling style aimed at creating desire in the patient to change their behavior.

To our knowledge, there have been no studies that investigated the impact of group MI on hearing aid use.

Hypothesis Standard care with motivational interviewing in a group setting does not alter the hearing aid usage when compared to the standard care alone in the new hearing aid users.

Study Methodology

Trial Objectives:

The purpose of this study is to determine the efficacy of group MI in improving adherence to hearing aid use, and to report the adverse effects of group MI if they exist.

Trial Design

  1. Settings The study will be a multi-center, prospective, randomized patient-blind controlled trial and employ a between-subject, pretest-posttest design.

    Study participants will be recruited at the audiology clinics located within the greater Vancouver region, BC. Audiology clinics will comply with Work safe BC and the Provincial Health Officer's COVID-19 orders as related to safety plans and best practices.

  2. Sample size determination Previous pilot research by Aazh (2016) suggests using a conservative estimation of effect size where d = 0.6 to estimate the sample size. A sample size of 180 participants (n = 90 in each group) will be required to achieve a level of significance of p = 0.05, power of 90%, at a randomization ratio of 1:1 and allowing for a 50% drop-out rate. We use a higher dropout rate than Aazh's study (50% vs. 20%) to compensate for the uncertainty surrounding COVID-19 pandemic. The estimated period for recruitment, intervention and data acquisition for this study is 48 months.
  3. Outcomes Differences in hearing aid use hours will be measured at each time point. This is a quantitative measure indicated by the mean number of hours the aid is used as recorded by the hearing aids' data logging feature. For bilateral hearing aid users, the mean number of hours will be calculated by averaging the left and right hearing aid use hours.

    Participants will also be asked to fill out the International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire (Cox \& Alexander, 2002) at each time point. This self-reported questionnaire is designed to measure the effectiveness of hearing aid interventions. The IOI-HA have been rigorously tested for their validity, reliability, and sensitivity (Cox \& Alexander, 2002; Vestergaard, 2006).

  4. Randomization Individuals who meet the inclusion criteria and provide informed consent will be assigned to a non-identifiable number sequence. Each sequence will have been previously allocated using block randomization to either treatment or control groups using a statistical software package, such as STATA. Block size variation will be used to prevent prediction of treatment. Creation of allocation lists will be done by the study coordinator, who will not be involved in data collection.

    • Treatment Group (MI group session + Standard care) Each participant in the treatment group will attend a 1-hour MI group session with 9 other participants hosted by a practicing MI therapies via Zoom at one month after the initial visit. This session will utilize MI to elicit motivation in each participant. Participants will also receive standard care delivered at in-person audiology clinic visits.
    • Control Group (Standard care) Each participant in the control group will receive standard care as typically delivered by audiologists at in-person audiology clinic visits. No additional treatment will be provided.
  5. Statistical Analysis Descriptive Statistics (means, standard deviation, frequency) will be used to summarize sample statistics. Repeated Measures (RM)-ANOVA tests will be conducted at each sampling interval to determine if there is a significant difference between the intervention and control groups with respect to the average number of hours the hearing aids are activated per day. Pearson's correlations will also be used to measure the strength of associations between hearing aid use hours via the data-logging feature and self-reported measures via the IOI-HA questionnaire. Data will be analyzed using STATA.
02

Conditions studied

  • Hearing Loss
  • Motivation
  • Hearing Disability
  • Hearing Disorders and Deafness

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03

In context

Deafness Reclassified

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 180 is above the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Compared within Deafness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years and older
  • New hearing aid user
  • Unilateral or bilateral hearing threshold above 25 dB in the worse ear (based on four-frequency PTA across 0.5, 1, 2 and 4 kHz, high-frequency PTA across 3, 4, 6, and 8 kHz, and low-frequency PTA across 0.5, 1 and 2 kHz)

Exclusion criteria

Exclusion Criteria:

  • History of hearing aid use
  • Do not understand the English language
  • Unable to complete the online questionnaires in English language
  • Have inconsistent pure-tone audiometric readings
  • Have medical constraints that prohibit them from wearing hearing aids
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
180 participants (estimated)

Study arms

  • No intervention
    Control

    Control groups that undergo standard audiological care

  • Experimental
    Treatment

    Treatment groups that undergo motivational interviewing with audiological care

    Behavioral: Motivational interviewing

Interventions

  • BehavioralMotivational interviewing

    Each participant in the treatment group will attend a 1-hour MI group session with 9 other participants hosted by a practicing MI therapies via Zoom at one month after the initial visit. This session will utilize MI to elicit motivation in each participant. Participants will also receive standard care delivered at in-person audiology clinic visits.

06

What researchers measure

Primary outcomes

  1. Hearing aid use hours

    Differences in hearing aid use hours will be measured at each time point

    Time frame: Study assessments will be performed during the initial visit, and at 1, 3, 6 and 12-month time points.

  2. Patient reported outcomes

    International Outcome Inventory for Hearing Aids questionnaire (Cox \& Alexander, 2002) at each time point.

    Time frame: Study assessments will be performed during the initial visit, and at 1, 3, 6 and 12-month time points.

07

Study locations

1 site
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References and documents

Publications

  • Liu AQ, Wijesinghe P, Lee M, Lau C, Sun J, Nunez DA. A randomized controlled trial evaluating the effects of motivational interviewing in new hearing aid users (MI-HAT): study protocol for a randomized controlled trial. Trials. 2023 May 22;24(1):346. doi: 10.1186/s13063-023-07352-7. PubMed 37217960 ↗
  • Aazh H. Feasibility of conducting a randomized controlled trial to evaluate the effect of motivational interviewing on hearing-aid use. Int J Audiol. 2016;55(3):149-56. doi: 10.3109/14992027.2015.1074733. Epub 2015 Sep 2. PubMed 26328620 ↗
  • Cox RM, Alexander GC. The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. Int J Audiol. 2002 Jan;41(1):30-5. doi: 10.3109/14992020209101309. PubMed 12467367 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2021 (actual). Primary completion is estimated for Dec 2026, 69 months after the start.

Of 50 non-industry interventional studies with no phase under Deafness, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20. This study's planned 69 months is above that.

Counting every sponsor, half of 58 studies reached it within 31 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2020
First posted
Dec 17, 2020
StartActual
Mar 16, 2021
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04673565
Responsible party
Desmond A Nunez (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Dec 17, 2020
Start date
Mar 16, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 7, 2026

Study contacts

Desmond Nunez, MBBS MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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