Effectiveness of the HEAR-aware smartphone app for hearing-impaired adults aged 50+ years who are not ready for a hearing aid
| ISRCTN | ISRCTN93742150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93742150 |
| Secondary identifying numbers | 2021.0153 |
- Submission date
- 28/04/2021
- Registration date
- 03/05/2021
- Last edited
- 24/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
An alarming two-thirds of adults aged 50+ years with hearing impairment who could benefit from hearing aids do not want any, leaving these adults with no support. To fill this gap, the HEAR-aware smartphone app may be offered as an alternative. The goal of the HEAR-aware smartphone app is to help adults with hearing loss self-manage their hearing problems. The app provides educational content tailored to a person's readiness to take action on their hearing and to a person's acoustic environment and associated challenges. The Hear-aware app may increase users’ readiness to take some form of action on their hearing loss. The study's findings should help to improve audiological rehabilitation for adults with hearing loss who are not ready for hearing aids.
Who can participate?
Adults with hearing loss who are 50 years and over and do not want a hearing aid.
What does the study involve?
Participants will be randomly assigned to either the app group or the control group. Participants in the app group will be asked to use the HEAR-aware app for a period of 4 weeks. Participants in the control group will receive no support (usual care). Measurements will be taken immediately before the 4 weeks of app use, directly after it and 4 weeks later. Measurements in the control group will be carried out at the same time as the app group., including readiness to take action, self-reported hearing disability, coping with hearing loss, prior hearing help-seeking, health-related quality of life, attitudes on hearing loss and hearing aids and self-efficacy of hearing help seeking.
What are the possible benefits and risks of participating?
Participants in the app group will obtain knowledge on how to cope with hearing loss in daily life and in particular in (listening) situations that they encounter and receive tailored information on how to improve these listening situations. Both groups contribute to the scientific knowledge on the effectiveness of aural rehabilitation other than hearing aids and this may be considered a benefit of participating. There are no risks associated with participation other than spending time filling out questionnaires.
Where is the study run from?
Amsterdam UMC – VU University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
May 2021 to December 2021
Who is funding the study?
1. Schoonenberg HoorSupport (Netherlands)
2. Sonova AG (Switzerland)
3. The PPP Allowance (Netherlands)
Who is the main contact?
Prof. dr. S.E. Kramer
se.kramer@amsterdamumc.nl
Contact information
Scientific
Dept. of Otolaryngology - Head and Neck Surgery
Section Ear & Hearing, Room PK2Y144
PO Box 7057
Amsterdam
1007 MB
Netherlands
 ORCID ID |
0000-0002-0451-8179 |
|---|---|
| Phone | +31 (0)204440969 |
| se.kramer@amsterdamumc.nl |
Study information
| Study design | Single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | How effective is the HEAR-aware smartphone app to increase readiness to take action of hearing-impaired adults aged 50+ years: a randomised controlled trial comparing the intervention group (4 weeks of HEAR-Aware app use) and the control group (no support) |
| Study acronym | HearAware |
| Study objectives | The increase in participants’ readiness to take action on their hearing will be higher in the HEAR-aware app group compared to the control group immediately after 1 month of app use and 4 weeks later. |
| Ethics approval(s) | The Institutional Review Board of the VU University Medical Center (official name: the Medical Ethics Review Committee of VU University Medical Center; registered under IRB00002991 [OHRP] and FWA00017598 [FWA]) located at De Boelelaan 1109, Postbox 7057, 1081 HV Amsterdam has reviewed the study and has confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to the study. Official approval of this study by the Medical Ethics Review Committee of VU University Medical Center is not required in this sense. Date of decision letter 26/04/2021, ref: 2021.0153 |
| Health condition(s) or problem(s) studied | Readiness to take action on hearing loss |
| Intervention | Participants will be randomized at an individual level using Castor EDC. Castor EDC uses the standard method of variable block randomization. The researchers use random block sizes of 4 and 6 as these are considered most suitable for their sample size. Due to the fact that participants in the intervention group will receive the app while the control group will receive no intervention, blinding of participants is not possible. Also, the two groups will receive a partly different set of questionnaires. In addition, the researchers will have to facilitate the app download for the intervention group. The intervention group will receive self-management support via the Hear-Aware app on their smartphone during a period of 4 weeks. Three times a day (at 9.30 am, 1 pm, and 7:30 pm), a push notification will show up including an invitation to do a short multiple-choice survey. The user is asked to enter listening situations that were (past), are (current) or will be (future) difficult for them given their hearing loss. Depending on the listening situation they enter, acoustic labels are selected activating the app to offer educational snippets matching the reported listening situation. Snippets can be instructions, strategies, tips offered through written text, video, a sound fragment, or a combination of these. The length may vary (2-10 min. reading/watching time), but most are shorter than 5 min. Every released snippet is stored in the user’s Personal Library, and can always be re-accessed. In total, 118 snippets are available, of which 81 can be released in response to a survey, and 37 are already available when starting up the app (i.e., making up the standard library). One snippet can cover multiple themes. The possible themes are: 1. Background knowledge on hearing 2. Communication strategies 3. Coping with impaired hearing 4. Understanding by loved ones 5. Hearing at work 6. Assistive listening devices - to be used without hearing aids 7. Hearing aids 8. Assistive listening devices- to be used with hearing aids 9. Fun The control arm receives no intervention (usual care). |
| Intervention type | Behavioural |
| Primary outcome measure | Readiness to take action is measured using the Stages of Change measurement The Line, a discrete 11-point scale ranging from 0 (not ready at all) to 10 (highly ready) at baseline (T0), immediately after 4 weeks of app use (T1) and 4 weeks later (T2). The Line is generic in nature and does not specify what ‘taking action on hearing’ is. As the HEAR‐aware app targets various target behaviors (e.g., communication strategies use, taking up hearing aids), Stages of Change will be measured both generically and specifically for these target behaviors. |
| Secondary outcome measures | 1. Self-reported hearing disability measured using the Amsterdam Inventory for Auditory Disability and Handicap at T0, T1 and T2 2. Coping measured using the Communication Profile for the Hearing Impaired (CPHI) at T0, T1 and T2 3. Prior hearing help-seeking steps taken measured by asking whether or not participants have ever taken help‐seeking steps (yes/no) (e.g. having visited a HAD/general practitioner/Ear Nose, and Throat doctor for a hearing test, performed a screening self‐test) at T0, T1 and T2 4. Health-related quality of life measured using the EQ5D at T0, T1 and T2 5. Attitudes on hearing loss and hearing aids measured using the Attitude Questionnaire at T0, T1 and T2 6. Self-efficacy of hearing help-seeking measured using the Self‐Efficacy of Hearing Help‐Seeking Scale (SEHHS) at T0, T1 and T2 |
| Overall study start date | 03/05/2021 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 84 |
| Total final enrolment | 87 |
| Key inclusion criteria | 1. Age 50 years or older 2. Minimum pure tone threshold of 35 dB HL (hearing level) averaged across 1, 2, and 4 kHz in at least one ear 3. Visited a hearing aid dispensing practice for a hearing test appointment or a subsequent intake appointment in the past 1.5 years, but decided to not pursue a hearing aid trajectory 4. Does not (yet) want a hearing aid 5. Never tried a hearing aid before 6. Owns an email account, smartphone (iPhone iOS 10 and higher, i.e. iPhone 5 or newer; Android 4.4 or higher, i.e., phone bought in 2015 or newer), and uses apps 7. Is fluent in Dutch 8. Is willing to use the app regularly (on a daily basis) |
| Key exclusion criteria | 1. Main complaint is tinnitus (and not hearing impairment). The HEAR-aware app does not have tinnitus coping as its main focus 2. Patient is referred to and enrolled in care through a multidisciplinary audiological center. The app has overlapping content with care provided in such a center |
| Date of first enrolment | 06/05/2021 |
| Date of final enrolment | 16/09/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3319 CH
Netherlands
Sponsor information
Hospital/treatment centre
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)204444444 |
|---|---|
| zorgsupport@vumc.nl | |
| Website | http://www.amsterdamumc.nl |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 18/09/2020 | 30/04/2021 | Yes | No | |
| Other publications | Feasibility of the HEAR-aware App sub study | 06/09/2023 | 30/01/2024 | Yes | No |
| Results article | 04/06/2024 | 24/07/2024 | Yes | No |
Editorial Notes
24/07/2024: Publication reference added.
30/01/2024: The following changes were made:
1. The intention to publish date was changed from 01/03/2023 to 01/10/2024.
2. Publication reference added.
29/12/2022: The following changes have been made:
1. The intention to publish date has been changed from 01/12/2022 to 01/03/2023.
2. The total final enrolment number has been changed from 89 to 87.
24/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/09/2021 to 16/09/2021.
2. The total final enrolment number has been added.
30/04/2021: Trial's existence confirmed by the Institutional Review Board of the VU University Medical Center.
