Evaluation of interactive videos for hearing aid users
| ISRCTN | ISRCTN11486888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11486888 |
| Secondary identifying numbers | 10200 |
- Submission date
- 03/09/2015
- Registration date
- 03/09/2015
- Last edited
- 19/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
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
Contact information
Scientific
Nottingham Hearing Biomedical Research Unit
Nottingham University Hospitals NHS Trust
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of interactive videos for enhancing benefit for new hearing aid users |
| Study 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(s) | 10/H0403/97 |
| 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 |
| Primary outcome measure | 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 study start date | 03/01/2011 |
| Overall study end date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200 |
| 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 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
- England
- United Kingdom
Study participating centre
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom
Sponsor information
Hospital/treatment centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
"ROR" |
https://ror.org/05y3qh794 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No |
