- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02233361
Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users
Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users.
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jorunn Solheim, Ph.d.
- Phone Number: +47 23225429
- Email: jorunn.solheim@lds.no
Study Contact Backup
- Name: Kari Kvaerner, Ph.d.
Study Locations
-
-
-
Oslo, Norway, 0456
- Recruiting
- Lovisenberg Diakonale Hospital
-
Contact:
- Kari Kvaerner, Ph.d.
-
Contact:
- Jorunn Solheim, Ph.d.
- Email: jorunn.solheim@lds.no
-
Principal Investigator:
- Jorunn Solheim, Ph.d.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 65 + years old
- Subjective and objective need for hearing aids.
Exclusion Criteria:
- Not being able to communicate in Norwegian.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of follow-up appointments on hearing aid use
Time Frame: 1 year
|
The counseling utilize Motivational Interviewing (MI) to promote hearing aid use.
Datalogging will be used to assess changes in hearing aid use.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hearing aid use measured with datalogging technology
Time Frame: When signed for the hearing aid and six month later
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Factor Barriers to hearing aid use
Time Frame: At the follow up appointment. Six month after the hearing aid was assigned for.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorunn Solheim, Ph.d., Lovisenberg Diakonale Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/2/0252
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.
Clinical Trials on Presbyacusis
-
Institut PasteurCEntre de Recherche et d'Innovation en Audiologie Humaine; Laboratoire de correction...Recruiting
Clinical Trials on Counseling
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Texas Christian UniversityTerminated
-
Lata Medical Research Foundation, NagpurUnknownMalnutrition in Pregnancy | Other Disorders of Breast and Lactation Associated With ChildbirthIndia
-
Port Said UniversityMansoura University; Prince Sattam Bin Abdulaziz UniversityRecruitingFertility IssuesEgypt
-
Loyola UniversityCompletedUterine Leiomyoma
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedAnxiety | Knowledge, Attitudes, Practice | Decision Making | Chromosome AbnormalityTurkey
-
University of PadovaFondazione Guido Berlucchi; Veneto Institute of Oncology I.O.V.-I.R.C.C.S.Terminated
-
International Centre for Diarrhoeal Disease Research...Completed
-
University of PennsylvaniaCompletedPolycystic Ovary Syndrome (PCOS)United States
-
UKK InstituteFinnish Institute of Occupational Health; Academy of Finland; Vitalmed Research...CompletedEffects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers (SF-Truck)Abdominal ObesityFinland