Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users

NCT ID: NCT02233361

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The proportion of elderly people is expected to increase greatly within the next couple of decades, resulting in a proportional increase in the need for hearing rehabilitation. However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus, a major challenge for audiological rehabilitation is facilitating the use of fitted hearing aids.

This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up appointment on hearing aid use, 2) to implement a specialized counselling program based on MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use with datalogging technology.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hearing impairment is one of the most common health issues among adults in Western countries. Socioeconomic status and level of family support are known to influence help-seeking among older hearing-impaired individuals. Although hearing loss can have significant adverse effects on an individual's quality of life, these effects have been found to be reversible through the use of hearing aids. Even short-time use has been found to improve the emotional and social experience of hearing impaired subjects. Unfortunately, of the approximately 200 000 people who have been provided with hearing aids in Norway, it is estimated that as many as 20-40% seldom or never use them. Lack of follow-up support and low motivation may explain why hearing impaired people do not use their hearing aids, but few research studies have addressed these issues.

The aim of this study is to evaluate two approaches for increasing hearing aid use, to obtain objective estimates of actual hearing aid use, to identify factors barriers to regular use and to study hearing aid use related to age and gender. The study will examine the extent to which follow-up appointments motivate use of hearing aids among people with hearing loss. A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed of the follow-up appointment. For decades, the use of hearing aids has been estimated using questionnaires. In the present study, hearing aid use will be objectively measured in hours pr.day using the hearing aid's datalogging. In addition, the study will develop, implement and evaluate a specialized counseling program for hearing aid users. Difficulties with and barriers to hearing aid use will be documented and analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Presbyacusis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Counseling

The intervention group will be informed in advance of a follow-up appointment six month after they have received their hearing aid. They will know that support will be given and time-use of the hearing aid will be checked out. Counseling on hearing aid use will be given.

Group Type EXPERIMENTAL

Counseling

Intervention Type BEHAVIORAL

A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed in advance.

Counselling

The control group will not receive any information of a follow-up appointment. However, they will receive a notice on this after six month.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Counseling

A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed in advance.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 65 + years old
* Subjective and objective need for hearing aids.

Exclusion Criteria

* Not being able to communicate in Norwegian.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jorunn Solheim, Ph.d.

Role: PRINCIPAL_INVESTIGATOR

Lovisenberg Diakonale Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lovisenberg Diakonale Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jorunn Solheim, Ph.d.

Role: CONTACT

+47 23225429

Kari Kvaerner, Ph.d.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jorunn Solheim, Ph.d.

Role: primary

Kari Kvaerner, Ph.d.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/2/0252

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motivational Interviewing in Hearing Aid Users
NCT04673565 ENROLLING_BY_INVITATION NA
Hearing Program in Primary Care
NCT05943509 ACTIVE_NOT_RECRUITING NA
Hearing Loss in Older Adults Study
NCT03382769 TERMINATED NA