Clinical trial NCT02233361: Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users
Official title: Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Presbyacusis
Keywords: Hearing rehabilitation
Elderly
Hearing aid use
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
First posted: 2014-09-08
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not being able to communicate in Norwegian.

Primary outcomes:
measure: The effect of follow-up appointments on hearing aid use
timeFrame: 1 year
Secondary outcomes:
measure: Hearing aid use measured with datalogging technology
timeFrame: When signed for the hearing aid and six month later
Other outcomes:
measure: Factor Barriers to hearing aid use
timeFrame: At the follow up appointment. Six month after the hearing aid was assigned for.
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
affiliation: Lovisenberg Diakonale Hospital
name: Jorunn Solheim, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: