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

Primary Purpose

Presbyacusis

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Counseling
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Presbyacusis focused on measuring Hearing rehabilitation, Elderly, Hearing aid use

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Not being able to communicate in Norwegian.

Sites / Locations

  • Lovisenberg Diakonale HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Counseling

Counselling

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 13, 2014
Last Updated
September 3, 2014
Sponsor
Lovisenberg Diakonale Hospital
Collaborators
Stiftelsen Helse og Rehabilitering
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1. Study Identification

Unique Protocol Identification Number
NCT02233361
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lovisenberg Diakonale Hospital
Collaborators
Stiftelsen Helse og Rehabilitering

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyacusis
Keywords
Hearing rehabilitation, Elderly, Hearing aid use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Counselling
Arm Type
No Intervention
Arm Description
The control group will not receive any information of a follow-up appointment. However, they will receive a notice on this after six month.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of follow-up appointments on hearing aid use
Description
The counseling utilize Motivational Interviewing (MI) to promote hearing aid use. Datalogging will be used to assess changes in hearing aid use.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hearing aid use measured with datalogging technology
Description
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.
Time Frame
When signed for the hearing aid and six month later
Other Pre-specified Outcome Measures:
Title
Factor Barriers to hearing aid use
Description
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.
Time Frame
At the follow up appointment. Six month after the hearing aid was assigned for.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 + years old Subjective and objective need for hearing aids. Exclusion Criteria: Not being able to communicate in Norwegian.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorunn Solheim, Ph.d.
Phone
+47 23225429
Email
jorunn.solheim@lds.no
First Name & Middle Initial & Last Name or Official Title & Degree
Kari Kvaerner, Ph.d.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorunn Solheim, Ph.d.
Organizational Affiliation
Lovisenberg Diakonale Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovisenberg Diakonale Hospital
City
Oslo
ZIP/Postal Code
0456
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorunn Solheim, Ph.d.
Email
jorunn.solheim@lds.no
First Name & Middle Initial & Last Name & Degree
Kari Kvaerner, Ph.d.
First Name & Middle Initial & Last Name & Degree
Jorunn Solheim, Ph.d.

12. IPD Sharing Statement

Learn more about this trial

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

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