Overview

Welcome to the FOUNDATION Study Website

Aim

The aim is to see if a trial could be conducted: this study will work with adults with severe-to-profound deafness and cochlear implant users to understand whether patients would be willing to take part in the bilateral trial recommended by NICE

Background

A cochlear implant is a device that can restore some hearing to a deaf ear. In the UK, cochlear implantation is the standard treatments for adults with ‘severe to profound’ deafness. This level of deafness means that without a cochlear implant these adults have difficulty understanding what people are saying even when they wear hearing aids. They have difficulty using the telephone and may be unable to hear important sounds like alarms, doorbells and traffic.

The NHS provides a cochlear implant for one ear even though these adults are deaf in both ears. Two cochlear implants could help them understand speech in noisy environments, know where to look to see who is talking and avoid hazards outdoors.

Trial Summary

What is the FOUNDATION study?

FOUNDATION is a feasibility study looking to inform a potential future clinical trial. This future clinical trial will compare a group of patients who have received one cochlear implant (unilateral implantation) with a group of patients who have received two cochlear implants (bilateral implantation). The participants in this future study will be assessed to see whether or not there is a measurable difference in quality of life between having one cochlear implant and having two.

The FOUNDATION study involves focus groups, questionnaires and an online survey which will be used to inform us as to whether or not a future study is feasible*.

Why are we doing it?

Currently, standard of care in the NHS for those with severe to profound deafness is unilateral cochlear implantation. The National Institute for Health and Care Excellence (NICE) have agreed that providing two cochlear implants, instead of just one, can provide additional benefits. Before this future trial can be conducted we need to gather further evidence to show that these additional benefits are worth the additional cost of providing the second cochlear implant. We will not know if two implants provide a greater benefit than just one implant unless we compare two groups of people, one group with just one implant and one group who have received two implants.

What has happened so far?

Focus groups took place in July 2017 and have helped inform the FOUNDATION study, please see our ‘Timeline’ page for further information.

Our online survey was open between March and May 2018, we had a fantastic response to this with nearly 150 participants completing the survey.

What is involved if I want to take part in the Foundation study?

Online Survey:

There is an online survey where candidates for cochlear implantation, cochlear implant users and healthcare professionals can complete a series of questions which will inform the future study. The link here will take you to this survey: (Link here if survey still open).

Quality of Life Questionnaires:

There are three centres involved in the study, patients will be asked if they are willing to complete a series of questionnaires during routine clinical appointments before and after unilateral cochlear implantation. This information will help the research team to understand the change in quality of life pre and post cochlear implantation. Questionnaires will take approximately 15 minutes to complete. The information gathered will help to inform the future clinical trial. There is further information on each centre and the teams involved on the "Recruiting Centres" page.

* You can read about each part of the study in more detail on the "Trial Timeline" page.

Registrations

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Recruiting Centres

Trial Timeline

Focus Groups

In July 2017 two patient-led focus groups were held to help us to design Foundation. The contribution of the focus groups has been extremely useful.

Focus Group Photo

Online Survey

The online survey has now closed, participation was fantastic with over 130 responses

Part of the study involves an online survey; those who are candidates for a cochlear implant (CI), a current CI user or a healthcare professional will be asked a series of questions in order to gain information for a potential future study. All answers to this survey will be anonymous and no personal data is collected. The information provided will be used to inform healthcare professionals as to whether or not a future clinical trial is feasible.

Multi centre screening exercise

Recruitment to the Multi-Centre Screening Exercise has now closed to recruitment. 65 participants were recruited to take part in the multi-centre screening exercise

This part of the study involves patients who have been referred to a cochlear implant centre being asked if they would be able to complete a series of questions. The information gathered will be anonymous and will inform the potential future study. Patient feedback is very important to us and we appreciate all the time and effort you will afford the study.

Care Pathway Working Group

The care pathway for cochlear implants has changed significantly since guidance on cochlear implantation was issued in the UK back in 2009. This part of the study will work with those who deliver cochlear implant services around the UK to gather information on what services look like today and how they operate. By gathering up to date information on how care is delivered, by whom, and how often, we can make much more accurate conclusions about whether bilateral implantation may be a good use of limited healthcare resources.

Contact

Please feel free to contact the FOUNDATION study team by any of the means below:

Telephone


00 44 (0) 151 795 8780

Address

Medicines for Children Clinical Trials Unit
Clinical Trials Research Centre
University of Liverpool
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP