Efficiency study of the Remote Check (RC) APP
- Conditions
- Effort aftercare of cochlear implants (hearing prosthesis)
- Registration Number
- DRKS00027512
- Lead Sponsor
- Cochlear Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 398
Experience with current CIs should be at least 1 year, and patients should already be in the follow-up phase.
- Participants must not have any disabilities in addition to hearing impairment, neurological diseases or cognitive impairments that could have an influence on the the course of the study and should not be participating in other ongoing studies at the same time.
- Furthermore, very good German language skills are required for the questionnaire.
Additional (technical) requirements for the RC+ group:
- The CI processors used are limited to Nucleus®7 and Nucleus® Kanso® 2.
- Patients must have a smartphone with the Cochlear™ Nucleus® smart app and the integrated Remote Check app
- Patients must still be (have been) able to perform the measurements of the Remote check app.
- Less than 1 year of experience with current CIs, or prior to entering the follow-up phase.
- Additional limitation that results in the subjects being unable to complete the questionnaire - even with unable to complete the questionnaire themselves - even with assistance (e.g. due to disability, dementia)
- no existing informed consent, or lack of possibility to give consent
- insufficient knowledge of German (assessment by the physicians/audiologists in charge).
- Furthermore, persons are excluded for whom the survey would represent too great a potential physical or mental burden (assessment by the attending physicians/audiologists).
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A1. Time recording of the effort of the two care variants (RC+ and RC-) for patients and audiologists<br>A2. Estimation of the mean time savings by using the Remote Check App in the follow-up of cochlear implant patients.<br>of cochlear implant patients (are there differences compared to follow-up without Remote Check App?) and deeper understanding of advantages and disadvantages of the respective provision<br>A3. Qualitative and quantitative aspects such as mental effort, exertion, subjective burden, etc.<br><br>Patients fill out a questionnaire, audiologists are interviewed (structured interview), the (temporal) course of a traditional on-site follow-up appointment is documented by a monitor.
- Secondary Outcome Measures
Name Time Method B1. Recording satisfaction with process and structural quality in order to relate it to monetary, time and other qualitative aspects.