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

Presbyacusis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02233361
• Other study ID #: 2013/2/0252
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2014
• Last updated: September 3, 2014
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: Lovisenberg Diakonale Hospital
• Contact: Jorunn Solheim, Ph.d.
• Phone: +47 23225429
• Email: jorunn.solheim[@]lds.no
• Is FDA regulated: No
• Health authority: Norway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 + years old

• Subjective and objective need for hearing aids.

Exclusion Criteria:

• Not being able to communicate in Norwegian.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Presbyacusis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonale Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Factor Barriers to hearing aid use	Difficulties with and barriers to hearing aid use will be documented and analyzed. Problems and barriers associated with hearing aid use will be recorded and categorized by the research team.	At the follow up appointment. Six month after the hearing aid was assigned for.	No
Primary	The effect of follow-up appointments on hearing aid use	The counseling utilize Motivational Interviewing (MI) to promote hearing aid use. Datalogging will be used to assess changes in hearing aid use.	1 year	No
Secondary	Hearing aid use measured with datalogging technology	The use of datalogging technology will strengthen the evaluation by providing an objective measure of hearing aid use. Real time use of hearing aids in hours per day will be assessed by connecting the instrument to the programming tool, Noah.	When signed for the hearing aid and six month later	No