Innovation of Hearing Rehabilitation and Effects of Reform
InHEAR
1 other identifier
interventional
751
1 country
1
Brief 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
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2021
CompletedFirst Submitted
Initial submission to the registry
November 14, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 25, 2022
July 1, 2022
1.2 years
November 14, 2021
July 22, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (6)
Patient-reported treatment effect
Month 3
Effect of hearing aid treatment
Month 3
Patient-reported satisfaction
Month 1
Patient-reported satisfaction
Month 2
Patient-reported satisfaction
Month 3
- +1 more secondary outcomes
Study Arms (3)
Test Group 1 (TG1)
EXPERIMENTALTG1 participants are testing the new digital assessment routine in a private setting. Audiology assistants in private hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The private hearing clinics also conduct hearing aid treatment for TG1 participants with simple hearing loss. TG21 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation.
Test Group 2 (TG2)
EXPERIMENTALTG2 participants are testing the new digital assessment routine in a public setting. Audiology assistants in public hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The public hearing clinics also conduct hearing aid treatment for TG2 participants with simple hearing loss. TG2 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation.
Control Group 3 (CG3)
ACTIVE COMPARATORCG3 participants will be assessed conventionally by a private practicing ENT specialist in the Region of Northern Jutland in Denmark at physical consultation in accordance with current Danish practice. CG3 participants with simple hearing loss can choose whether hearing aid treatment should be conducted in either a private or a public hearing clinic. CG3 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation.
Interventions
Remote digital assessment of test group participants
Conventional physical assessment of control group participants
Eligibility Criteria
You may qualify if:
- Subjective hearing difficulty
- Must be able to understand and read Danish
You may not qualify if:
- Recent ENT specialist assessment
- Prior HA usage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Otorhinolaryngology and Audiology, Aalborg University Hospital
Aalborg, 9000, Denmark
Related Publications (1)
Siggaard LD, Jacobsen H, Hougaard DD, Hogsbro M. Digital vs. physical ear-nose-and-throat specialist assessment screening for complicated hearing loss and serious ear disorders in hearing-impaired adults prior to hearing aid treatment: a randomized controlled trial. Front Digit Health. 2023 Jun 8;5:1182421. doi: 10.3389/fdgth.2023.1182421. eCollection 2023.
PMID: 37363275DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Morten Hoegsbro, MD, PhD, MSc
Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 14, 2021
First Posted
December 13, 2021
Study Start
March 16, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
July 25, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share