Motivational Interviewing in Hearing Aid Users (MI-HAT)
Primary Purpose
Hearing Loss, Motivation, Hearing Disability
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
Control groups that undergo standard audiological care
Treatment groups that undergo motivational interviewing with audiological care
Outcomes
Primary Outcome Measures
Hearing aid use hours
Differences in hearing aid use hours will be measured at each time point
Patient reported outcomes
International Outcome Inventory for Hearing Aids questionnaire (Cox & Alexander, 2002) at each time point.
Secondary Outcome Measures
Full Information
NCT ID
NCT04673565
First Posted
December 13, 2020
Last Updated
May 16, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04673565
Brief Title
Motivational Interviewing in Hearing Aid Users
Acronym
MI-HAT
Official Title
A Randomized Controlled Trial Evaluating the Effects of Motivational Interviewing in New Hearing Aid Users
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
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.
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.
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).
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Motivation, Hearing Disability, Hearing Disorders and Deafness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The study will be a multi-center, prospective, randomized patient-blind controlled trial and employ a between-subject, pretest-posttest design.
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control groups that undergo standard audiological care
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment groups that undergo motivational interviewing with audiological care
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hearing aid use hours
Description
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.
Title
Patient reported outcomes
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26328620
Citation
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.
Results Reference
background
PubMed Identifier
12467367
Citation
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.
Results Reference
background
PubMed Identifier
16938796
Citation
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.
Results Reference
background
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Motivational Interviewing in Hearing Aid Users
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