Condition category
Ear, Nose and Throat
Date applied
15/01/2018
Date assigned
23/01/2018
Last edited
26/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with hearing loss struggle to hold conversations with others. This can be socially isolating and lowers quality of life. Hearing aids help overcome hearing loss. However, many people know little about them. Hearing aids can be difficult to use and do not give perfect hearing. Many hearing aids are therefore abandoned or underused. In the past, we have worked with hearing aid users to produce multimedia, interactive educational videos about how best to use hearing aids and to communicate well. We have shown that these videos improve patient’s knowledge of hearing aids and communication. They have also increased hearing aid use and improved patient’s confidence. Educational videos can be improved by tailoring them to the needs of each person. They can also be more easily accessed by running them on the internet. Mobile devices, such as smartphones and tablet computers, provide an ideal means to achieve this. This research aims to work with hearing aid users to adapt our existing educational videos for use with people’s own mobile devices. Informed by the views of first-time hearing aid users, we plan to develop a larger study. This is to see whether our new educational videos, delivered through mobile devices, really make a difference to the lives of those affected by hearing loss. If they do, we plan to find out how and why. The overall study goal is to improve hearing aid use by helping hearing aid users to self-manage their condition.

Who can participate?
Adults aged 18 and older who are first-time hearing aid users.

What does the study involve?
Participants are asked to try out educational videos on their own devices. After 10-12 weeks participants are asked questions about how they got on with them, what worked and what made a difference to them.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
1. Nottingham Biomedical Research Centre (BRC) (UK)
2. Nottingham Audiology Adult Services (UK)

When is the study starting and how long is it expected to run for?
February 2018 to September 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Melanie Ferguson
melanie.ferguson@nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melanie Ferguson

ORCID ID

http://orcid.org/0000-0002-8096-869X

Contact details

National Institute for Health Research Nottingham Biomedical Research Centre
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom
+44 115 823 2600
melanie.ferguson@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33776

Study information

Scientific title

The development and feasibility of m-health technologies to improve hearing aid use and benefit in first-time hearing aid users

Acronym

Study hypothesis

The aim of this study will establish the feasibility of a theoretically-driven, personalised educational intervention delivered through mobile technologies in first-time hearing aid users.

Ethics approval

East of England – Cambridgeshire and Hertfordshire Research Ethics Committee, 28/03/2017, ref: 17/EE/0117

Study design

; Both; Design type: Prevention, Psychological & Behavioural, Rehabilitation, Qualitative

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat; UKCRC code/ Disease: Ear/ Diseases of middle ear and mastoid

Intervention

A theoretically-driven, personalised educational intervention delivered through mobile technologies based on the C2Hear (https://www.youtube.com/C2HearOnline) multimedia videos, or Reusable Learning Objects (RLOs). The intervention will include shorter 'bite-sized' RLOs suitable for mobile technologies (or mRLOs), which will also enable individualised learning.

Participants are asked to try out the videos on the their own devices. After 10-12 weeks participants speak to each user individually. Participants are asked questions about how they got on with them, what worked and what made a difference to them.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Hearing aid use is measured using datalogging (i.e. use in hours per day internal to the hearing aid) following 10-12 weeks of independent use of the mRLO intervention.

Secondary outcome measures

1. Self-reported hearing-related handicap and disability is measured using the Glasgow Hearing Aid Benefit Profile (GHABP) Part I at baseline
2. Self-reported hearing aid use, benefit, satisfaction and residual disability is measured using the GHABP Part II following 10-12 weeks of independent use of the mRLO intervention
3. Hearing-specific quality of life is measured using the Hearing Handicap Inventory for the Elderly (HHIE) at baseline and immediately post-intervention
4. Hearing aid self-efficacy is measured using the Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA) at baseline and following 10-12 weeks of independent use of the mRLO intervention
5. Social behaviours and perceptions are measured using the Social Participation Restrictions Questionnaire (SPaRQ) at baseline and following 10-12 weeks of independent use of the mRLO intervention
6. Hearing aid knowledge is measured using the Hearing Aid and Communication Knowledge (HACK) questionnaire at baseline and following 10-12 weeks of independent use of the mRLO intervention
7. Working memory is measured using the Wechsler Adult Intelligence Scale Digit Span task at baseline and following 10-12 weeks of independent use of the mRLO intervention
8. Change in hearing difficulty is measured using the Clinical Global Impression scale following 10-12 weeks of independent use of the mRLO intervention
9. Participants will be asked if they experienced any adverse effects arising from the intervention 10-12 weeks of independent use of the mRLO intervention

Overall trial start date

18/04/2017

Overall trial end date

30/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults aged ≥18 years (no upper age limit)
2. First-time hearing aid users (or if previous users, but not having worn hearing aids for more than 3 years)
3. English as first spoken language or good understanding of English. It is important that participants can understand the content of the resources and work with the interactive elements, as well as be able to answer outcome questionnaires, to ensure valid data are collected.
4. Familiar with mobile technologies (e.g. owns a smartphone or tablet device, or uses one regularly)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 77; UK Sample Size: 77

Participant exclusion criteria

Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.

Recruitment start date

05/02/2018

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Institute for Health Research (NIHR)
Nottingham Biomedical Research Centre (BRC) Ropewalk House 113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Trial participating centre

Nottingham Audiology Adult Services
Nottingham University Hospitals NHS Trust Ropewalk House 113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor details

Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination of the research findings will be far-reaching and aim to cover as many potential avenues as possible to ensure maximal coverage of results to Audiology and relevant professionals, government and policymakers, researchers, educational institutes, people with hearing loss and hearing aid users.
1. Talks and poster presentations at national and international conferences and meetings, primarily Audiology and ENT (e.g. British Academy of Audiology, British Society of Audiology, American Academy of Audiology), and INVOLVE conference
2. Publish articles in peer-reviewed national and international journals in accordance with TIDieR guidance. It is anticipated that most publications will be in hearing and auditory science journals
3. Publish articles in professional newsletters (e.g. British Academy of Audiology, British Society of Audiology, ENT and Audiology News, Audiology Today (USA))
4. Publish articles in newsletters of relevant national (e.g. Action on Hearing Loss, Hearing Link, The Ear Foundation) and local charities (e.g. Nottingham Deaf Society), in addition to utilising their social media and communication channels, which we have agreed in advance.
5. Disseminate articles and media clips through web-based activities (e.g. youtube videos, podcasts, blogs, NIHRTV)
6. Collaborate with professional audiology and policy making organisations (eg. British Society of Audiology Practice Guidance, British Academy of Audiology, GP-led clinical commissioning groups), and NHS England (e.g. Chief Scientific Office) to include research findings in documentation and guidelines
7. Examples of learning resources made available to relevant newsletters and at public events (e.g. Deaf Awareness Week) and other organisations (e.g. Nottingham Deaf Society)
8. Press releases and interviews with local and national media (e.g. radio, television, newspapers)
9. Findings to research participants via newsletter and talks and open days

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/09/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/01/2018: Internal review