The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial

April 6, 2015 updated by: US Department of Veterans Affairs
This study compares the effectiveness of hearing aid appointments provided in a group format to those provided in an individual format. We are asking if hearing aid training with group appointments is as good as or better than with individual appointments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The number of hearing aids dispensed by the VA has nearly quadrupled from 75,000 in 1996 to over 283,000 in 2003. However, the number of audiologists serving this population has less than doubled (72% increase) in the same period. This imbalance has resulted in burgeoning waiting times for audiology appointments, negatively impacting the quality of life of thousands of veterans while they wait for hearing aids. Reduction in waiting times through more efficient use of limited resources while maintaining high quality care is of great interest to VA leadership. Objectives: The orientation portion of the hearing aid fitting appointment and the hearing aid follow-up visit 4 The researcherseks later impart standard information relevant to all new hearing aid patients, and may be highly conducive to group format. Our specific aims are to compare group and the current standard of individual aural rehabilitation appointments to determine if: 1) group visits are at least as effective ('non-inferior') as individual visits for each audiology appointment, and 2) the use of group visits leads to lower costs for the VA. Methods: The researchers propose a non-inferiority, randomized clinical trial to compare the effectiveness of group vs. individual audiology appointments. The researchers will compare group vs. individual visits for two types of audiology appointments: hearing aid fitting (orientation only) and hearing aid follow-up. The researchers hypothesize that: 1) group visits are at least as effective as individual visits, as measured by hearing-related quality of life and hearing aid adherence, and 2) group visits lead to cost savings, not just in the immediate treatment period, but throughout a 6-month aural rehabilitation period. Setting and Population. The researchers propose to enroll 660 new hearing aid patients from the audiology clinics at the Seattle and American Lake Divisions of VA Puget Sound Health Care System. Randomized Interventions. Patients will be randomized to group vs. individual orientation (intervention #1) and group vs. individual follow-up (intervention #2) visits. Status: Recruitment is completed. The primary effectiveness outcome will be hearing-related quality of life 6 months after the hearing aid fitting. Secondary effectiveness outcomes will include hearing aid adherence and satisfaction with hearing amplification. Cost and utilization outcomes will include audiology labor for the initial visits and subsequent unplanned visits, the cost of hearing aids, and the number of hearing aid repairs. The researchers selected a time frame of 6 months because pilot data show that 75% of unplanned visits occur in the first 6 months. Analysis. An intention-to-treat analysis will be used to minimize bias due to subject self-selection. The researchers have chosen a sample size adequate to detect non-inferiority of hearing-related quality of life in patients undergoing group rehabilitation in either intervention. Analyses for each intervention will be stratified by degree of hearing loss, binaural vs. monaural hearing aid use, and group vs. individual appointment of the other intervention. Cost-effectiveness analyses will be pursued if greater effectiveness and higher costs are both documented, in which case pilot calculations of the unit cost to obtain an additional successfully treated patient (those with a clinically important improvement of 6 points on the Inner EAR scale) will be made. Benefit to VA. This proposal directly addresses three of the VA's designated research areas: sensory disorders, aging, and health services. In addition, this application is directly responsive to an HSR&D Solicitation on sensory disorders and loss. This project has the potential to help VA leadership identify more efficient treatment that maintains high quality care for one of the most common disabilities in veterans, and to provide insight into the value of group visits as a model of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
660

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

New hearing aid users at VA Puget Sound; eligible for VA hearing aids

Exclusion Criteria:

Prior hearing aid users; Inability to participate in a group rehabilitation sessions or to complete follow-up

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Arm 1
Procedure: Group hearing aid fittings
Procedure: Group hearing aid follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Hearing-related quality of life, hearing aid adherence

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Satisfaction, costs, utilization

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
US Department of Veterans Affairs

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margaret P. Collins, PhD MS, VA Puget Sound Health Care System Seattle Division, Seattle, WA

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLI 04-265

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.

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