Condition category
Ear, Nose and Throat
Date applied
03/09/2015
Date assigned
03/09/2015
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hearing loss, or deafness, is a very common condition which develops as people get older. There are two main types of hearing loss: conductive hearing loss, where the problem is in the middle ear (i.e. in the ear drum) and sensorineural hearing loss (SNHL), where the problem lies in the inner ear (cochlea), or the nerve that carries information from the ear to the brain for interpretation. People suffering from SNHL often use hearing aids, as this type of hearing loss cannot be corrected surgically and so is usually permanent. People can find it quite trying to have to use hearing aids, and so new ways are being developed to improve their experiences. The aim of this study is to find out whether providing patients with interactive videos (multimedia reusable learning objects) can help people who are beginning to use hearing aids in their day-to-day life.

Who can participate?
Adults using a hearing aid for the first time, with mild to moderate sensorineural hearing loss in their better ear.

What does the study involve?
In the first stage of the study, reusable learning objects (RLO's) are created, in the form of online videos and DVD’s, to provide advice and information to help people to cope with having to use hearing aids. In the second stage of the study, participants are randomly allocated into two groups. Participants in the first group are provided with RLO’s to add to the information given by audiologists at their hearing aid fittings. Participants in the second group are not provided with RLO’s.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Nottingham Hearing Biomedical Research Unit (UK)

When is the study starting and how long is it expected to run for?
January 2011 to May 2013

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

Who is the main contact?
Dr Melanie Ferguson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melanie Ferguson

ORCID ID

Contact details

Nottingham Hearing Biomedical Research Unit
Nottingham University Hospitals NHS Trust
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10200

Study information

Scientific title

Evaluation of interactive videos for enhancing benefit for new hearing aid users

Acronym

HEAR-IT

Study hypothesis

The overall aim is to assess whether interactive, multimedia reusable learning objects (RLOs) to supplement information provided by audiologists at the HA fitting resulted in enhanced benefit and use for first-time HA users.

Objectives are to:
1. Develop a series of short RLO's to provide a broad range of auditory rehabilitation advice and information, accessible via DVD or the internet.
2. Establish uptake and compliance of the RLO's.
3. Assess knowledge and understanding of general principles of HAs, listening and communication tactics.
4. Assess the benefits and cost-effectiveness of the RLO's

Ethics approval

10/H0403/97

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Ear, nose and throat; Subtopic: Ear (all Subtopics); Disease: Ear, nose & throat

Intervention

HEAR-IT: Educational programme on practical and psycho-social aspects of hearing loss, hearing aid sand communication, based on the concept of reusable learning objects.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Subjective hearing aid use measured by the Glasgow Hearing Aid Benefit Profile, 6-weeks post hearing aid fitting.

Secondary outcome measures

1. EQ-5D measured at hearing aid fitting and 6 weeks post hearing aid fitting
2. Hearing Aid and Communication Knowledge questionnaire (HACK) measured 6 weeks post hearing aid fitting
3. Hearing aid use (datalogging); measured 6 weeks post hearing aid fitting
Hearing Handicap Inventory for the Elderly (HHIE) measured 6 weeks post hearing aid fitting
4. Hospital Anxiety and Depression Scale (HADS) measured at hearing aid fitting and 6 weeks post hearing aid fitting
5. International Outcome Inventory for Hearing Aids (IOI-HA) measured 6 weeks post hearing aid fitting
6. Practical Hearing Aid Skills Test (PHAST) measured 6 weeks post hearing aid fitting
7. Satisfaction with Amplification with Daily Life (SADL) measured 6 weeks post hearing aid fitting
8. Short Form Patient Activation Measure (PAM) measured at hearing aid fitting and 6 weeks post hearing aid fitting

Overall trial start date

03/01/2011

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. First time hearing aid users
3. Sensorineural hearing loss in the better hearing ear (puretone average >20 dB over 0.25, 0.5, 1, 2 and 4 kHz).
4. English as a first spoken language or a good understanding of English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200

Participant exclusion criteria

1. Inability to use the interactive videos and do not have family members or friends to assist them
2. Inability to complete the questionnaires with assistance due to age-related problems (e.g. cognitive decline and dementia)
3. No access to DVD player and television, or computer
4. Patients who require an additional followup appointment after hearing aid fitting as part of their individual management plan

Recruitment start date

03/01/2011

Recruitment end date

31/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Nottingham Hearing Biomedical Research Unit Ropewalk House 113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor details

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26565785

Publication citations

Additional files

Editorial Notes