Innovation of Hearing Rehabilitation and Effects of Reform

Hearing Loss Clinical Trial

— InHEAR  

Official title:

Innovation of Hearing Rehabilitation and Effects of Reform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154539
• Other study ID #: InHEAR
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine.

The aim of this study is to investigate:

Primarily:

1. Patient safety of remote vs. conventional assessment

2. Patient-reported satisfaction and treatment effect of remote vs. conventional assessment

Secondarily:

3. Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine

4. Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire.

The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users.

Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022.

Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.

Description:

InHEAR is a prospective randomized controlled trial aimed to investigate a new, Danish digital remote assessment routine applied in 751 hearing-impaired adults. The existing, traditional Danish referral model requires a physical consultation with an ear-nose- and throat (ENT) specialist prior to treatment initiation. The digital referral reform replaces the traditional physical ENT specialist assessment with a standardized examination package performed by educated and experienced audiology assistants, allowing physicians to assess and refer hearing-impaired adults to the relevant treatment regime remotely and asynchronously without meeting the patients physically.

After inclusion, the participants will be randomized equally into three groups:

Test group 1 (TG1) will be testing the digital assessment routine in private hearing clinics.

Test group 2 (TG2) will be testing the digital assessment routine in public hearing clinics.

Control group 3 (CG3) will be assessed in accordance with current Danish practice.

The examination package performed on test group participants comprises of:

1. A standardized, focused medical hearing history record (questionnaire)

2. A standard audiometry test, including air conduction, bone conduction, speech discrimination test and acoustic reflex test

3. Tympanometry

4. Still images of the eardrums performed by video-otoscopy

Four ENT-specialists, two audiologists and to private ENT specialist, will independently and remotely assess the standardized test group examination packages and refer the test group participants to relevant treatment. Participants in the control group are assessed by a private ENT specialist at a physical consultation and referred to relevant treatment in accordance with current Danish practice. Participants with simple hearing loss will be offered hearing rehabilitation with hearing aids. Participants with complicated hearing loss or complicated ear related diseases will be offered a physical ENT specialist assessment at the Department of Audiology at Aalborg University Hospital prior to treatment initiation.

Patient-reported data concerning treatment satisfaction-, quality- and effect will be registered throughout the study period.

Two-three months after treatment initiation, all participants are evaluated by an ENT specialist in Audiology or Otology at a "golden standard" physical consultation at the Department of Audiology at Aalborg University Hospital. Assessment and referral accuracy, patient-reported treatment quality and satisfaction between the test groups and the control group participants will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 751
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjective hearing difficulty

• Must be able to understand and read Danish

Exclusion Criteria:

• Recent ENT specialist assessment

• Prior HA usage

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Diagnostic Test:
• Remote digital assessment
Remote digital assessment of test group participants
• Conventional physical assessment
Conventional physical assessment of control group participants

Locations

Country	Name	City	State
Denmark	Department of Otorhinolaryngology and Audiology, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults	ENT specialist assessments were performed remotely in test group participants and physically in control group participants at baseline. Based on this assessment, participants were divided into three categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. Hearing aid treatment was administered when indicated.; The primary focus was to correctly identify participants with severe/complicated hearing loss and/or complicating ear-related conditions in both test and control groups.	Baseline
Primary	Remote ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.	A physical, "golden standard" ENT assessment was performed in all test group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the remote ENT assessment at baseline and diagnostic differences were registered.; Outcome measures: Sensitivity and specificity of the remote ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.	Month 3
Primary	Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.	A physical, "golden standard" ENT assessment was performed control group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the physical ENT assessment at baseline and diagnostic differences were registered.; Outcome measures: Sensitivity and specificity of the conventional physical ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.	Month 3
Primary	Remote vs. physical ENT assessment on correct diagnosis of severe/complicated hearing loss and/or complicating ear-related conditions.	Comparison of sensitivity and specificity of remote vs. physical ENT assessment on correct identification of severe/complicated hearing loss and/or complication ear-related conditions in hearing impaired adults (p-values for comparison).	Month 3
Secondary	Patient-reported treatment effect	The Speech, Spatial- and Qualities of Hearing Scale questionnaire af hearing aid treatment (SSQ12B) provides a score correlated to the subjective hearing difficulty severity after hearing aid treatment is initiated.; Possible scores ranged from -5 (a worsening of conditions after HAs) to 5 (an improvement of conditions after HAs).	Month 3
Secondary	Effect of hearing aid treatment	The International Outcome Inventory for Hearing Aids (IOI-HA) covers a minimal set of seven core outcome items. The items are practically oriented and comprise a mini-profile more than a scale.	Month 3
Secondary	Patient-reported satisfaction	A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered.; The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction)	Month 1
Secondary	Patient-reported satisfaction	A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered.; The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction)	Month 2
Secondary	Patient-reported satisfaction	A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered.; The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction)	Month 3
Secondary	HA usage time	Overall and average daily usage time (hours) was registered digitally from the hearing aids 3 months after treatment initiation.	Month 3