Motivational Interviewing in Hearing Aid Users (MI-HAT)

May 16, 2022 updated by: Desmond A Nunez, University of British Columbia

A Randomized Controlled Trial Evaluating the Effects of Motivational Interviewing in New Hearing Aid Users

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control groups that undergo standard audiological care
Experimental: Treatment
Treatment groups that undergo motivational interviewing with audiological care
Behavioral: Motivational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing aid use hours
Time Frame: Study assessments will be performed during the initial visit, and at 1, 3, 6 and 12-month time points.
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
Time Frame: Study assessments will be performed during the initial visit, and at 1, 3, 6 and 12-month time points.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20-02393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss

Clinical Trials on Motivational interviewing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe