NCT04673565

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

December 13, 2020

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hearing aid use hours

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

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

  • Patient reported outcomes

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

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

Study Arms (2)

Control

NO INTERVENTION

Control groups that undergo standard audiological care

Treatment

EXPERIMENTAL

Treatment groups that undergo motivational interviewing with audiological care

Behavioral: Motivational interviewing

Interventions

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.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Publications (4)

  • 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.

    PMID: 26328620BACKGROUND
  • 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.

    PMID: 12467367BACKGROUND
  • Vestergaard MD. Self-report outcome in new hearing-aid users: Longitudinal trends and relationships between subjective measures of benefit and satisfaction. Int J Audiol. 2006 Jul;45(7):382-92. doi: 10.1080/14992020600690977.

    PMID: 16938796BACKGROUND
  • 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.

MeSH Terms

Conditions

Hearing LossHearing DisordersDeafness

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study will be a multi-center, prospective, randomized patient-blind controlled trial and employ a between-subject, pretest-posttest design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 17, 2020

Study Start

March 16, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations