DeafnessCOCHLESURVNCT02890576
Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV
An observational study of Deafness, run by University Hospital, Toulouse.
Trial summary
The number of patients with cochlear implants increases every year, constituting an active queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380 adult patients). The number of approved cochlear implant centers is limited by guardianships, and corresponds to the Hospitals University. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness
- What is being tested?
- telemedicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with deafness and having a cochlear implant
Who may be able to join
- Adult patient (> 18 years), carrying a cochlear implant,
- Familiar with using the Internet and with equipment (computer and computer video camera) at his home
- Agreeing to participate in the study,
- With a social protection system.
Who cannot join
- Misunderstanding of login procedures,
- Failure to follow procedures,
- Person under a legal protection system (guardianship, curators or safeguard justice)
- Pregnancy or breastfeeding.
About this study
Official title: Organization of Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant.
The number of patients with cochlear implants increases every year, constituting an active queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380 adult patients). The number of approved cochlear implant centers is limited by guardianships, and corresponds to the Hospitals University. It is not possible to create networks of correspondents. Teams of implantation centers must meet the needs of new patients and ensure continuity of care for patients already implanted: speech therapy monitoring, adjustment and rehabilitation.
In case of malfunction of the implant, patients use in first-line reference center. The increasing number of patients leads to a lack of specialized teams that can not meet the demands of patients in a timely manner, while continuing to provide support for new patients. It is therefore necessary to find solutions to improve the service provided to patients who received a cochlear implant system to respond quickly and effectively to the request of troubled patients, while optimizing the workload of the teams . The introduction of a telemedicine platform is expected to achieve these goals, distinguishing minor malfunctions, not requiring a consultation in a center, and the most complex situations requiring consultation in a center.
Read the detailed description
The strategy of the study is to establish contact with the patient at home in case of problems through the establishment of a daily continuously in service by telephone contact and video calling.
There will be no change in the usual care of the patient. The monitoring center by health professionals (speech therapists, technicians and doctors ORL) in the cochlear implant center will operate a daily permanence of 5 half days on business days, to respond to a patient call.
Are excluded from this research, emergency management such as meningitis, which passes through the usual emergency lane.
- Conditions
- Deafness
- Being tested
- telemedicine
- Keywords
- cochlear implant, telemedicine, new organization of patient monitoring
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicineOther
Monitoring of patients with cochlear implant with sessions of telemedicine
| Study group | Role | What they receive |
|---|---|---|
| telemedicine | Setting up of a new organization of medical monitoring (ussing telemedicine) of patient having a cochlear implant Receives: Other: telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of movements avoided the center,
number of contacts have avoided moving the patient to the center
Measured: 12 months after the inclusion
Secondary outcomes (2)
The delay for the identification of malfunction
Measured: Up to 1 year
The time spent by the health professional during a telemedicine session
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: study was stopped du to of patient lack
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Deguine, MD, PhD, Principal investigator, Hospital University of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890576
- Sponsor's protocol ID
- 13 6900 15
- Acronym
- COCHLESURV
- Status last verified
- Jul 2019
- First submitted
- 21 Jul 2016
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organization of Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant.
- ClinicalTrials.gov ID
- NCT02890576
- Acronym / sponsor ID
- COCHLESURV / 13 6900 15
- Conditions
- Deafness
- Keywords
- cochlear implant, telemedicine, new organization of patient monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study was stopped du to of patient lack
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of patients with cochlear implants increases every year, constituting an active queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380 adult patients). The number of approved cochlear implant centers is limited by guardianships, and corresponds to the Hospitals University. It is not possible to create networks of correspondents. Teams of implantation centers must meet the needs of new patients and ensure continuity of care for patients already implanted: speech therapy monitoring, adjustment and rehabilitation.
In case of malfunction of the implant, patients use in first-line reference center. The increasing number of patients leads to a lack of specialized teams that can not meet the demands of patients in a timely manner, while continuing to provide support for new patients. It is therefore necessary to find solutions to improve the service provided to patients who received a cochlear implant system to respond quickly and effectively to the request of troubled patients, while optimizing the workload of the teams . The introduction of a telemedicine platform is expected to achieve these goals, distinguishing minor malfunctions, not requiring a consultation in a center, and the most complex situations requiring consultation in a center.
Detailed description
The strategy of the study is to establish contact with the patient at home in case of problems through the establishment of a daily continuously in service by telephone contact and video calling.
There will be no change in the usual care of the patient. The monitoring center by health professionals (speech therapists, technicians and doctors ORL) in the cochlear implant center will operate a daily permanence of 5 half days on business days, to respond to a patient call.
Are excluded from this research, emergency management such as meningitis, which passes through the usual emergency lane.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telemedicine | – | Other: telemedicineSetting up of a new organization of medical monitoring (ussing telemedicine) of patient having a cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with deafness and having a cochlear implant
Key inclusion criteria (4 listed)
- Adult patient (> 18 years), carrying a cochlear implant,
- Familiar with using the Internet and with equipment (computer and computer video camera) at his home
- Agreeing to participate in the study,
- With a social protection system.
Key exclusion criteria (4 listed)
- Misunderstanding of login procedures,
- Failure to follow procedures,
- Person under a legal protection system (guardianship, curators or safeguard justice)
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedicineMonitoring of patients with cochlear implant with sessions of telemedicine | Other | telemedicine |
Primary outcome
the number of movements avoided the center,
Time frame: 12 months after the inclusion
number of contacts have avoided moving the patient to the center
2 secondary outcomes
The delay for the identification of malfunction
Time frame: Up to 1 year
The time spent by the health professional during a telemedicine session
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- Background: PubMed 20053272Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Deguine, MD, PhD principal investigator
Hospital University of Toulouse
Questions about this trial
What is this clinical trial studying?
An observational study of Deafness, run by University Hospital, Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of movements avoided the center, (time frame: 12 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.