Remote Monitoring Applied to Cochlear Implant Patient Follow-up (TELESURVIC)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- The degree of auditory rehabilitation achieved with the cochlear implant.
研究概览
简要总结
The cochlear implant (CI) is a device to compensate severe or profound deafness. The CI has a lifetime implanted part and an external processor. Regular monitoring is necessary because the device can generate complications and when the device is dysfunctional, the patient becomes deaf again. Our center, the CRIC, is a center for monitoring and fitting CI. Follow-up requires face-to-face procedures and some patients have difficulty accessing the center.
Our cohort of patients is growing steadily and now exceeds 750 patients. Provision should be made for sustained steady growth and enabling means. Telemedicine may be a response for the follow-up of some patients.
Currently, cochlear implanted patients benefit once a year from: an ENT (Ear Nose and Throat) medical consultation, a speech-language assessment, physical verification of the external processor, an audiometric test, a fitting of the external processor. This makes it possible to check the absence of medical complication, the use and the correct functioning of the external and internal parts.
Provision should be made for sustained steady growth and enabling means. With the development of new hearing tests, technical possibilities of some speech processors and software for their fitting, telemedicine may be a response for the follow-up of some patients.
TELESURVIC will study the feasibility for patients implanted with an implant Cochlear™ to carry out a complete test of their equipment by themselves.
For this project we will use a tablet device, without simultaneous contact with CRIC professionals. On this tablet are installed calibrated hearing tests, tutorials of good maintenance of the processor and a software of adjustment allowing the realization of the operations desired for an inspection of the implant.
Patients selected to participate, (on a voluntary basis), in this protocol will follow the following steps:
- They will first be trained in the use of the tablet at the CRIC by professionals. Patients will only be included if they are autonomous in handling the tablet and specific software;
- They will carry out the various tests at the hospital on the tablet: audiometry test in quiet and in noise then checking of the data logging, self-fitting thanks to the Cochlear software (NFS);
- Between one week and one month later, they will come back to the center and will do the same tests alone in a quiet room of the center.
- Outside the patient's presence, the data will be analyzed and compared with the data collected in step 2, in order to validate or not, the feasibility of these self-administrated tests without any help by the team.
详细描述
The selection of the patients is made on study of the files of the cochlear implanted patients with leading implant COCHLEARTM, compatible external processor with the research and being able to potentially realize only the studied acts.
The unit proposes then during a consultation or by explanatory e-mail, to the patient to participate in a training workshop. The information note will be presented to the patient during the consultation, or sent by e-mail.
After checking the selection criteria and signing the consent by the patient, the patient joins a training workshop.
During the workshop, bringing together 3 to 5 patients supervised by an ENT doctor of the +/- adjuster team, a speech therapist and +/- a COCHLEARTM engineer, patients will be trained in the handling of the tablet and software. Then, in a second step, each patient will have to carry out the hearing and self-adjustment tests by themselves in a quiet room in the unit. He will be able to reach a unit professional who can help him.
The patient will benefit from auditory evaluation by a consonants discrimination test and a 3-digit noise test and then an evaluation of the implant and processor parameters using COCHLEARTM NFS tuning software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old
- •Cochlear implantation older than 6 months (with a COCHLEAR implant and processor allowing wireless connection), followed by CRIC or IFIC,
- •Fluent in the French language,
- •Possibility of carrying out the acts alone in person in the service within a short time (less than 30 days).
- •Patients affiliated to a social security scheme or entitled to it
- •Patient who has signed informed consent form
排除标准
- •Difficulty mastering the tests alone or handling the tablet that will be entrusted to him
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons hospitalized without consent and without legal protection, and persons admitted to a health or social institution for purposes other than research.
- •Adults who are subject to a legal protection measure (guardianship, trusteeship or judicial protection), adults who are unable to express their consent and are not subject to a protection measure
研究组 & 干预措施
self-adjustment tests
For patients with an implant Cochlear™, we will be trained during workshop, to use a tablet how to do some tests; They will do alone, by themselves the tests, just after the workshop and 8 to 30 days later.
Self audiometric test : digit triplet test, consonants discrimination test, Self-fitting of cochlear implant
干预措施: Self-adjustment tests (Device)
结局指标
主要结局
The degree of auditory rehabilitation achieved with the cochlear implant.
时间窗: Between day +8 to +30 after the training session
Comparison of the data collected (The hearing tests 3 digits test and VCV) during the usual evaluations in the department, then in auditory self-test and of the parameters of reaction just after an apprenticeship and at a distance, between 8 to 30 days, of this learning
次要结局
- Estimate time savings for patients(Between day +8 to +30 after the training session)
- Estimate the degree of patients satisfaction, on the use of new tools that will be used for remote monitoring(Between day +8 to +30 after the training session)
- Estimate the degree of satisfaction professionals, on the use of new tools that will be used for remote monitoring(Between day +8 to +30 after the training session)
- Estimate the necessary adaptations of the medical team and patients(Between day +8 to +30 after the training session)
- Estimate time savings for professionals(Between day +8 to +30 after the training session)