Hearing ImpairmentNCT03687801
Clinically Implementing Online Hearing Support Within Hearing Organization
A study testing Online hearing support in people with Hearing Impairment, run by Sodra Alvsborgs Hospital at 1 site in Sweden.
Trial summary
Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services. Several studies have shown that hearing support can be carried out without in-person meetings and lead to significant benefits for hearing aid users. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Online hearing support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- 24 Sep 2018to 16 Aug 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the hearing aid users to be 20 yr of age or above,
- the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
- the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of >20 points (indicative of some residual self-reported hearing problems).
Who cannot join
- the hearing aid users who are not fulfilling the conditions to participate.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Hearing Clinic, Hearing Organization
Borås, Vastra Gotalandsregion, 501 82
About this study
Official title: Clinically Implementing Online Hearing Support
Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services. Several studies have shown that hearing support can be carried out without in-person meetings and lead to significant benefits for hearing aid users. Interventions for persons with hearing impairment improve communication and improve outcomes more than hearing aid use alone.
The first purpose of this study is needs-oriented and the second purpose is research-oriented. The needs-oriented purpose of this project is to, via a national website of health information and services for Sweden, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, provides ("standard care").
Read the detailed description
Aural rehabilitation The most common approach to hearing impairment is hearing aid fitting as a part of aural rehabilitation (AR). In Sweden, approximately 50% of those who could benefit from hearing aids are fitted with them, and nearly half of those use their hearing aids to a considerable extent every day. Despite addressing the hearing impairment with hearing aids, many hearing aid users experience substantial communication difficulties that can affect their performance in daily life situations. This could cause patients to stop using their hearing aids, which may negatively affect their interpersonal interactions and involvement in community life.
Adjusting to hearing impairment involves more than just hearing aid fitting, although hearing aid fitting is a step in the right direction. Additional steps within AR, such as learning about the condition and providing perceptual training and counseling, need to be included in order to minimize the negative effects of a hearing impairment on social interactions and quality of life. These additional steps can effectively be included variously throughout the AR (separately or in combination, and individually or in groups), they may increase hearing aid use and satisfaction, and can be performed as an adjunct to or a supplement for hearing aid fitting. However, even though combining these additional steps with hearing aid use has proven to be beneficial, most hearing aid users are unaware of and are not offered any other rehabilitation measures than hearing aid fitting. This deficiency could be due to clinicians experiencing lack of time and difficulties scheduling interventions in addition to hearing aid fitting. It could also be due to the presumably increased costs of adding extra support to hearing aid fitting. These aspects could hinder audiologist's in general clinical practice from providing holistic care. Thus, the overall availability of comprehensive AR is low.
Internet interventions Online interventions and healthcare information is cost-effective. Online hearing healthcare has increased in recent years and is empowering for persons with hearing impairment. Telehealth (i.e., telephone and internet) offers a more cost-effective approach to hearing healthcare and increases the possibilities for the audiologist to reach out to persons with hearing impairment. Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services.
Effective internet interventions have four important interactive design features: 1) social context and support, 2) contacts with intervention, 3) tailoring, and 4) self-management. Patient participation is central for self-management to be successful. For example, a person with hearing impairment can apply knowledge obtained in communication training to reduce hearing-related problems. The role of the audiologist in delivering social contact and support, and contacts with the intervention, seems to be of particular importance in online audiology interventions.
Purpose With this project we want to provide online support to hearing aid users. Further on, we want to document the effectiveness of the online support compared to traditional support that the Hearing Organization, VGR, provides ("standard care").
The needs-oriented purpose: The project is a part of a collaboration between 1177 Care-Guide and region Vastra Gotaland (VGR). 1177 Care-Guide is a national website of health information and services for Sweden. Every region customizes its 1177 Care-Guide. Regions use the 1177 Care-Guide platform to provide online services. The needs-oriented purpose of this project is to, via 1177, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, VGR, provides ("standard care"). Traditional support ("standard care") in Sweden differs across and within counties, in particular in terms of the number of visits and the content of comprehensive AR. The costs of amplification for the person with hearing impairment may also vary across counties.
- Conditions
- Hearing Impairment
- Being tested
- Online hearing support, Standard care
- Keywords
- audiologic rehabilitation, hearing loss, patient education, patient participation, structured rehabilitation, internet interventions, counseling
- Medical subject headings
- Hearing Loss, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online hearing supportBehavioural
The intervention group will follow an online hearing support for five weeks
Standard careBehavioural
The control group will follow standard care during the time the intervention group receives online haring support
| Study group | Role | What they receive |
|---|---|---|
| Online hearing support | Experimental | The intervention group will have access to online hearing support for five weeks. The online hearing support will include a program that consists of three elements: 1) reading material; 2) reading instructions and weekly assignments related to the reading material; and 3) online and telephone interaction with a professional. Receives: Behavioral: Online hearing support |
| Standard care | Active comparator | The control group will have access to traditional support that the Hearing Organization provides ("standard care"). Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is assessed for the Hearing Handicap Inventory for the Elderly (HHIE)
The HHIE measures the experience of hearing loss in older people by focusing on the psychosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
Measured: change from baseline HHIE at 5 weeks, change from baseline HHIE at 6 months, change from baseline HHIE at 1 year
Secondary outcomes (1)
Change is assessed for the Communication Strategies Scale (CSS)
CSS (from the Communication Profile for the Hearing Impaired) The CSS is designed to analyze participants' behavior in various communication situations via three subscales: maladaptive behaviors (9 questions that analyze behaviors that hinder communication) and verbal strategies and nonverbal strategies (16 items related to strategies that can enhance communication). The 1 to 5 scoring reflects how frequently a specific situation or behavior occurs.
Measured: change from baseline CSS at 5 weeks, change from baseline CSS at 6 months, change from baseline CSS at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start24 Sep 2018
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodra Alvsborgs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milijana Malmberg, Sodra Alvsborgs Hospital
- Investigators
- Milijana Malmberg, PhD, Principal investigator, Hörselverksamheten, Habilitering & Hälsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687801
- Sponsor's protocol ID
- e-Hearing
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Implementing Online Hearing Support
- ClinicalTrials.gov ID
- NCT03687801
- Acronym / sponsor ID
- e-Hearing
- Conditions
- Hearing Impairment
- Keywords
- audiologic rehabilitation, hearing loss, patient education, patient participation, structured rehabilitation, internet interventions, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sodra Alvsborgs HospitalUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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.
Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services. Several studies have shown that hearing support can be carried out without in-person meetings and lead to significant benefits for hearing aid users. Interventions for persons with hearing impairment improve communication and improve outcomes more than hearing aid use alone.
The first purpose of this study is needs-oriented and the second purpose is research-oriented. The needs-oriented purpose of this project is to, via a national website of health information and services for Sweden, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, provides ("standard care").
Detailed description
Aural rehabilitation The most common approach to hearing impairment is hearing aid fitting as a part of aural rehabilitation (AR). In Sweden, approximately 50% of those who could benefit from hearing aids are fitted with them, and nearly half of those use their hearing aids to a considerable extent every day. Despite addressing the hearing impairment with hearing aids, many hearing aid users experience substantial communication difficulties that can affect their performance in daily life situations. This could cause patients to stop using their hearing aids, which may negatively affect their interpersonal interactions and involvement in community life.
Adjusting to hearing impairment involves more than just hearing aid fitting, although hearing aid fitting is a step in the right direction. Additional steps within AR, such as learning about the condition and providing perceptual training and counseling, need to be included in order to minimize the negative effects of a hearing impairment on social interactions and quality of life. These additional steps can effectively be included variously throughout the AR (separately or in combination, and individually or in groups), they may increase hearing aid use and satisfaction, and can be performed as an adjunct to or a supplement for hearing aid fitting. However, even though combining these additional steps with hearing aid use has proven to be beneficial, most hearing aid users are unaware of and are not offered any other rehabilitation measures than hearing aid fitting. This deficiency could be due to clinicians experiencing lack of time and difficulties scheduling interventions in addition to hearing aid fitting. It could also be due to the presumably increased costs of adding extra support to hearing aid fitting. These aspects could hinder audiologist's in general clinical practice from providing holistic care. Thus, the overall availability of comprehensive AR is low.
Internet interventions Online interventions and healthcare information is cost-effective. Online hearing healthcare has increased in recent years and is empowering for persons with hearing impairment. Telehealth (i.e., telephone and internet) offers a more cost-effective approach to hearing healthcare and increases the possibilities for the audiologist to reach out to persons with hearing impairment. Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services.
Effective internet interventions have four important interactive design features: 1) social context and support, 2) contacts with intervention, 3) tailoring, and 4) self-management. Patient participation is central for self-management to be successful. For example, a person with hearing impairment can apply knowledge obtained in communication training to reduce hearing-related problems. The role of the audiologist in delivering social contact and support, and contacts with the intervention, seems to be of particular importance in online audiology interventions.
Purpose With this project we want to provide online support to hearing aid users. Further on, we want to document the effectiveness of the online support compared to traditional support that the Hearing Organization, VGR, provides ("standard care").
The needs-oriented purpose: The project is a part of a collaboration between 1177 Care-Guide and region Vastra Gotaland (VGR). 1177 Care-Guide is a national website of health information and services for Sweden. Every region customizes its 1177 Care-Guide. Regions use the 1177 Care-Guide platform to provide online services. The needs-oriented purpose of this project is to, via 1177, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, VGR, provides ("standard care"). Traditional support ("standard care") in Sweden differs across and within counties, in particular in terms of the number of visits and the content of comprehensive AR. The costs of amplification for the person with hearing impairment may also vary across counties.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online hearing support | Experimental | Behavioral: Online hearing supportThe intervention group will have access to online hearing support for five weeks. The online hearing support will include a program that consists of three elements: 1) reading material; 2) reading instructions and weekly assignments related to the reading material; and 3) online and telephone interaction with a professional. |
| Standard care | Active comparator | Behavioral: Standard careThe control group will have access to traditional support that the Hearing Organization provides ("standard care"). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the hearing aid users to be 20 yr of age or above,
- the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
- the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of >20 points (indicative of some residual self-reported hearing problems).
Key exclusion criteria (1 listed)
- the hearing aid users who are not fulfilling the conditions to participate.
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 |
|---|---|---|
| Online hearing supportThe intervention group will follow an online hearing support for five weeks | Behavioural | Online hearing support |
| Standard careThe control group will follow standard care during the time the intervention group receives online haring support | Behavioural | Standard care |
Primary outcome
Change is assessed for the Hearing Handicap Inventory for the Elderly (HHIE)
Time frame: change from baseline HHIE at 5 weeks, change from baseline HHIE at 6 months, change from baseline HHIE at 1 year
The HHIE measures the experience of hearing loss in older people by focusing on the psychosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
1 secondary outcome
Change is assessed for the Communication Strategies Scale (CSS)
Time frame: change from baseline CSS at 5 weeks, change from baseline CSS at 6 months, change from baseline CSS at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Milijana Malmberg, PhD principal investigator
Hörselverksamheten, Habilitering & Hälsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online hearing support in people with Hearing Impairment, run by Sodra Alvsborgs Hospital at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 18 Sep 2019. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is assessed for the Hearing Handicap Inventory for the Elderly (HHIE) (time frame: change from baseline HHIE at 5 weeks, change from baseline HHIE at 6 months, change from baseline HHIE at 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 18 Sep 2019.