PresbyacusisNCT02233361
Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users
A study testing Counseling in people with Presbyacusis, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Presbyacusis
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 + years old
- Subjective and objective need for hearing aids.
Who cannot join
- Not being able to communicate in Norwegian.
Trial locations and contacts
1 site in 1 country.
Kari Kvaerner, Ph.d. contact
Norway1 site, 1 recruiting
- Recruiting
Lovisenberg Diakonale Hospital
Oslo, 0456
Jorunn Solheim, Ph.d., jorunn.solheim@lds.no
Kari Kvaerner, Ph.d.
About this study
Official title: 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.
Read the 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.
- Conditions
- Presbyacusis
- Being tested
- Counseling
- Keywords
- Hearing rehabilitation, Elderly, Hearing aid use
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | 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. Receives: Behavioral: Counseling |
| Counselling | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: When signed for the hearing aid and six month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyacusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Responsible party
- Sponsor
- Investigators
- Jorunn Solheim, Ph.d., Principal investigator, Lovisenberg Diakonale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233361
- Sponsor's protocol ID
- 2013/2/0252
- Status last verified
- Sep 2014
- First submitted
- 13 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users.
- ClinicalTrials.gov ID
- NCT02233361
- Acronym / sponsor ID
- 2013/2/0252
- Conditions
- Presbyacusis
- Keywords
- Hearing rehabilitation, Elderly, Hearing aid use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: CounselingThe 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. |
| Counselling | No intervention | –The control group will not receive any information of a follow-up appointment. However, they will receive a notice on this after six month. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 + years old
- Subjective and objective need for hearing aids.
Key exclusion criteria (1 listed)
- Not being able to communicate in Norwegian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingA 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. | Behavioural | Counseling |
Primary outcome
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 secondary outcome
Hearing aid use measured with datalogging technology
Time frame: When signed for the hearing aid and six month later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Kvaerner, Ph.d. contact
Jorunn Solheim, Ph.d. principal investigator
Lovisenberg Diakonale Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Presbyacusis, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorunn Solheim, Ph.d. (+47 23225429, jorunn.solheim@lds.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of follow-up appointments on hearing aid use (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.