Impact of Treating Unilateral and Bilateral Severe-to-profound Sensorineural Hearing Loss on Productivity and Social Wellbeing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hearing Loss, Sensorineural, Severe
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in sick leave after 3, 6 and 12 months
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Project synopsis:
This prospective cohort study investigates impact of (1) hearing loss and (2) cochlear implantation on cost and health state on one hand, and employment, productivity and social wellbeing on the other hand in a professionally active group using validated questionnaires.
Participants:
The investigators aim to include 100 professional active adults between 18 and 65 years old. All participants have a bilateral severe-to-profound sensorineural or mixed hearing loss. Due to several reasons such as an optimal hearing aid fitting, the presence of a residual hearing or physical contra-indications, half of these participants will not be implanted with CI. Additionally, 100 participants with a single-sides deafness (SSD) in the acute or chronic setting (SDD present for at least three months) will be included.
Study design
Study measures:
All audiological tests and patient-reported outcome measures will be included in this test protocol and repeated throughout the follow-up visits depending on aided or unaided setting. The cognitive evaluation will be executed during the first and last test moment.
The investigators anticipate that the protocol will take 1 hour per follow-up in the hospital (audiological testing and to go over the questionnaires), plus an extra hour at home to fill out the questionnaires. For the cognitive tests, an extra hour in the hospital will be scheduled.
Hypothesis
As a primary endpoint, the investigators anticipate demonstrating that severe-to-profound hearing loss has a significant impact on sick leave and self-reported productivity.
Health state will also be analyzed as a secondary endpoint because the investigators anticipate only marginal improvement (if any) on these instruments due to the lack of sensitivity and responsiveness, even in this population. The investigators will also determine the rate of usage and non-usage at this long-term follow-up to demonstrate the utility of cochlear implants.
Statistical analysis
IBM SPSS Statistics (IBM; Armonk, NY) will be used for the statistical analyses. The participants' hearing profiles will be summarized using descriptive statistics (median, and range). In view of the sample size, non-parametric tests and linear mixed models (to describe evolution in time and difference between groups) will be used. Quantitative data will be presented as median and range (minimum and maximum). Descriptives will be used to summarize the outcomes of the subjective data logging. For the speech perception in noise results, a Wilcoxon signed-rank test will be used. In addition, to correct for the multiple speech in noise test configurations, Holm's correction will be applied. The level of significance will be set at p.0.05.
Data storage
REDCap (Research Electronic Data Capture) is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides an interface for data entry (with data validation) and audit trails for tracking data manipulation and export procedures. Data will be pseudomized before storage in REDCap.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 65 years
- •Unilateral or bilateral severe-to-profound sensorineural or mixed hearing loss
- •Ability to understand and speak Dutch
- •Resident in Flanders
Exclusion Criteria
- •Already implanted with a cochlear implant
- •Conductive hearing loss
- •Congenital hearing loss
- •Inability to complete audiological or cognitive evaluation
- •Inability to complete questionnaires
Outcomes
Primary Outcomes
Change in sick leave after 3, 6 and 12 months
Time Frame: Baseline; 3 months; 6 months; 12 months
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem. To determine the impact of hearing loss on work productivity the investigators will use "hearing loss" as the specific health problem to develop the WPAI: Hearing as a responsive tool to evaluate work productivity in a hearing impaired population. This questionnaire consists of six items. Four different outcomes will be calculated: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. A higher percentage (minimum=0%; maximum= 100%) on each subscale indicates a greater impact on work productivity.
Change in self-reported productivity after 3, 6 and 12 months
Time Frame: Baseline; 3 months; 6 months; 12 months
The Work Limitations Questionnaire (WLQ) measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ items ask respondents to rate their level of difficulty or ability to perform specific job demands. The WLQ's 25 items are aggregated into four scales: time management scale, physical demands scale, cognitive job tasks and output demands scale. Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. Additionally, using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss where a high score indicates that the participant is limited for a great amount of time.
Secondary Outcomes
- Subjective data logging CI(12 months)
- Change in anxiety and depression after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in medical cost after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in socio-professional reintegration after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in cognition based on the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H) after 3, 6 and 12 months(Baseline; 12 months)
- Change in health state based on the EQ-5D-5L after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in health state based on the Health Utilities questionnaire (HUI-3) after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Objective data logging CI(12 months)
- Change in treatment-specific health-related Quality of Life based on the Amsterdam Inventory for Auditory Disability and Handicap (AIADH) after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in general sense of preceived self-efficacy after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in need for recovery after work after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in speech perception in noise after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in hearing thresholds after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in treatment-specific health-related Quality of Life based on the Nijmegen Cochlear Implant Questionnaire (NCIQ) after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)
- Change in visuospatial short-memory after 3, 6 and 12 months(Baseline; 12 months)
- Change in speech perception in quiet after 3, 6 and 12 months(Baseline; 3 months; 6 months; 12 months)