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Innovation of Hearing Rehabilitation and Effects of Reform

NCT05154539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2022-07-25

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Remote digital assessment

Remote digital assessment of test group participants

DIAGNOSTIC_TEST

Conventional physical assessment

Conventional physical assessment of control group participants

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Morten Hoegsbro, MD, PhD, MSc · Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154539 on ClinicalTrials.gov