Condition category
Ear, Nose and Throat
Date applied
15/01/2018
Date assigned
23/01/2018
Last edited
26/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hearing aids are the most common intervention for hearing loss. However, the majority of people who get them do not use them. This is an issue because hearing loss can lead to communication difficulties, resulting in reduced quality of life. Rehabilitation programs can help people to use their hearing aids and interact in social settings more effectively. Programs delivered via the internet may also help people with hearing loss access them. This study is looking at an online rehabilitation program for people with hearing loss. The program covers different topics, including information about hearing aids, ways to improve communication, and relaxation techniques. The program aims to help people use their hearing aids and interact in social settings more effectively. The program is made up of 5 modules that cover different topics such as hearing aids, communication strategies, and relaxation techniques. The study aims to see whether a study assessing the program can be done in people with hearing loss in the publically-funded UK National Health Service (NHS). This study will make sure that the program is clear and that it covers the right topics. This will help the research team to prepare for a study that will test how effective the program is in larger group of people.

Who can participate?
Adults aged 18 and older who get hearing aids for the first time and people who have worn hearing aids for at least one year or more.

What does the study involve?
Participants are asked to attend two study visits. On the first visit (up to 1 and half hours in total) participants are asked a number of questionnaires about their hearing and how it affects their day-to-day life. They are also shown how to use the online program. After this session, they are asked to complete up to five modules of the program. Each module takes up to one hour to complete, and each participant will have up to one-week to complete a module. After completing the modules, participants are asked a number of questionnaires about their hearing and their experiences with hearing aids. Some participants may also be invited to take part in a small group discussion that takes place on a separate day. The group discussion lasts no more than 1.5 hours. With the researcher and other participants, they are able to share their views on the program, such as what they liked or disliked.

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. NIHR Nottingham Hearing Biomedical Research Unit (UK)
2. Nottingham Audiology Adult Services (UK)
3. Adult Audiology Department (UK)

When is the study starting and how long is it expected to run for?
November 2016 to June 2019

Who is funding the study?
Oticon A/S (Denmark)

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

NIHR Nottingham Hearing Biomedical Research Unit
113 The Ropewalk
Ropewalk House
Nottingham
NG1 5DU
United Kingdom
+44 0115 823 2600
melanie.ferguson@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32078

Study information

Scientific title

Assessing the feasibility of a clinical trial of an online audiological rehabilitation program

Acronym

Study hypothesis

Hypothesis:
The study will determine the feasibility of conducting a full-scale clinical trial assessing the effectiveness of an online audiological rehabilitation program in an NHS clinical sample of adult hearing aid users.

The study will estimate the following feasibility parameters:
Recruitment
1. Willingness of clinicians to recruit participants
2. Willingness of participants to consent
3. Number of eligible patients

Feasibility/acceptability of approach (Quantitative outcomes)
1. Characteristics of the outcome measures
2. Standard deviation of outcome measures to estimate sample size
3. Follow-up rates, response rates to questionnaires, adherence/compliance rates
4. Time needed to collect and analyse data

Users’ perspective/opinions of the intervention (Qualitative outcomes)
1. Participant’s views regarding delivery of the program through different devices
2. How the program is used and how often (i.e. usability)
3. Participants views concerning what they like and dislike about the program (i.e. acceptability)
4. How much of the program is completed (adherence)

Ethics approval

Yorkshire & The Humber- Leeds East Research Ethics Committee, 23/09/2016, ref: 16/YH/04220

Study design

; Both; Design type: Process of Care, 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/ Other disorders of ear

Intervention

An online audiological rehabilitation program, the Eriksholm Guide to Better Hearing, is issued to an NHS clinical sample of i) first-time, and ii) existing adult hearing aid users. The internet-based intervention consists of up to five-weekly, one-hour modules that each include self-studies, training, and professional video coaching in hearing loss, hearing aids, and communication strategies.

Study participants participate in the study for up to 8 hours. This includes 1.5 hours for baseline measures, up to one-hour to complete each weekly module of the Eriksholm Guide to Better Hearing, and up to 1.5 hours post-intervention measures.

A sub-sample of 16 participants are invited to take part in focus groups lasting 1.5 hours, increasing the participation time in the sub-sample to 9.5 hours.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Hearing-specific quality of life is measured using the Hearing Handicap Inventory for the Elderly (HHIE) at baseline and immediately post-intervention.

Secondary outcome measures

1. Hearing aid benefit is measured using the Glasgow Hearing Aid Benefit Profile (GHABP) and International Outcome Inventory for Hearing Aids (IOI-HA) at baseline and immediately post-intervention
2. Hearing aid self-efficacy is measured using the Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA) at baseline and immediately post-intervention
3. Social behaviours and perceptions are measured using the Social Participation Restrictions Questionnaire (SPaRQ) at baseline and immediately post-intervention
4. Hearing aid skills are measured suing the Practical Hearing Aid Skills Test (PHAST) at baseline and immediately post-intervention
5. Hearing aid knowledge is measured using the Hearing Aid and Communication Knowledge (HACK) questionnaire at baseline and immediately post-intervention
6. Change in hearing difficulty is measured using the Clinical Global Impression scale immediately post-intervention
7. Participants’ views of the intervention will be measured using a purpose-designed feedback questionnaire and, in a sub-group of participants (N=16), focus groups immediately post-intervention

Overall trial start date

01/11/2016

Overall trial end date

30/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ability to give informed consent
2. English as first spoken language or good understanding of English
3. Adults aged ≥18 years (no upper age limit)
4. Mild-to-moderate hearing loss (average hearing threshold across octave frequencies 0.25-4kHz ≥20 and ≤70dB HL[1])
5. Have either:
5.1. Used hearing aids for at least one year (existing hearing aid users), or
5.2. Have not used hearing aids or alternative form of amplification (e.g. personal sound amplification product) within the past two years (first-time hearing aid users)
6. Access the Internet and compatible device (e.g. computer or tablet device)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Report having severe tinnitus
2. Diagnosis of Ménière’s disease
3. Patients who are unable to complete the questionnaires with assistance due to age-related problems such as cognitive decline and dementia

Recruitment start date

21/11/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR Nottingham Hearing Biomedical Research Unit
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

Trial participating centre

Adult Audiology Department
Chesterfield Royal Hospital NHS Foundation Trust Calow
Chesterfield
S44 5BL
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

Research Governance
Research and Graduate Services
King’s Meadow Campus
Lenton Lane
Nottingham
NG7 2RD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Oticon Fonden

Alternative name(s)

Oticon Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Denmark

Results and Publications

Publication and dissemination plan

Dissemination of the study findings will cover the following avenues:
1. Talks and poster presentations at national and international conferences, primarily Audiology (e.g. British Academy of Audiology Annual Conference). Estimated between June 2018 and January 2019.
2. Planned publication in peer-reviewed national or international journal (e.g. International Journal of Audiology). Estimated between June 2018 and January 2019.
3. Publish article in professional newsletter (e.g. ENT and Audiology News). Estimated between June 2018 and January 2019.
4. Newsletter to all participants who took part in the research, including results. Estimated between June 2018 and January 2019.

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

31/01/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/01/2018: Internal review. 23/01/2018: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.