A study on the effectiveness of a support programme (SUPR) for adult hearing aid users

• Register: ISRCTN
• Last refreshed on: 5 October 2020
• Main ID: ISRCTN77340339
• Date of registration: 27/01/2016
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center Amsterdam (Netherlands)
• Public title: A study on the effectiveness of a support programme (SUPR) for adult hearing aid users
• Scientific title: Addition of a SUpport PRogramme (SUPR) to usual hearing aid care as offered by the hearing aid dispenser – What are the effects on coping, hearing aid use and experienced hearing disabilities?
• Date of first enrolment: 01/02/2016
• Target sample size: 569
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN77340339
• Study type: Interventional
• Study design: Multicentre interventional cluster randomized controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Janine F.J. Meijerink

Key inclusion & exclusion criteria

Inclusion criteria:
1. Are at least 50 years old
2. Are open to the possibility to take up a new hearing aid on one or both ears (at the time of the preparation appointment at the hearing aid dispenser)
3. Purchase a new hearing aid on one or both ears (after the two-month trial period)
4. Have sufficient understanding of the Dutch language (speaking, writing, reading)
5. Have access to a personal computer (desktop, laptop, palmtop, iPad/tablet, smartphone) with an internet connection for the total duration of the study

Exclusion criteria:
Hearing aid dispenser clients who:
1. Also receive care at a specialized Audiological Clinic, since this mostly involves people with complex hearing disabilities. This care may overlap and/or interfere with that of the support programme
2. Receive a hearing aid primarily to suppress tinnitus complaints. For these individuals the focus of the rehabilitation is not on restoring communication per se and as such, they are not part of the target group


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

To improve hearing-impaired individuals' communication and personal adjustment to their disability, more than hearing aid fitting alone is needed
Ear, Nose and Throat

Intervention(s)

At the beginning of the study hearing aid dispenser shops will be randomly assigned to offer care as usual (hearing aid care) or hearing aid care including SP. This means that the clusters are defined at the start of the study and the particular hearing aid dispenser shop that the participant visits automatically determines to which group the participant is assigned (Care as Usual or SP). To avoid an unequal distribution of the level of urbanization across the participants of the two groups, shops will be pre-stratified on different levels of urbanization and the randomisation will subsequently be performed within these different strata. The level of urbanization is based on the level of the particular municipality that the shop is localized in. A statistician will perform block randomisation, with blocks of four.

The support programme (SP) is designed to help hearing-impaired individuals use their hearing aid more effectively and to improve communication strategies and personal adjustment, as compared to usual hearing aid care. All participants, including the ones assigned to the control group, are asked to assign a communication partner; a person with whom the participant has regular contact. The communication partner plays an important role in enhancing the motivation of the participant.

Participants who are assigned to the SP arm will be provided with the support programme for a period of six months (two month trial period and four months afterwards) in addition to receiving usual care in the context of hearing aid fitting. The Support Program consists of the Practical Support Book and the following components offered via email:
1. Contact with the hearing aid dispenser, in order to support the user

Primary Outcome(s)

Primary outcome measures as of 14/11/2018:
The use of communication strategies, measured with the Communication Profile for the Hearing Impaired (CPHI) at baseline and after 6 (T1), 12 (T2) and 18 (T3) months. Communication strategies are measured using the following three CPHI-subscales: maladaptive behaviours, verbal strategies and non-verbal strategies.

Primary outcome measures as of 31/01/2017:
The use of communication strategies and personal adjustment to hearing impairment, measured with the Communication Profile for the Hearing Impaired (CPHI) at baseline and after 6 (T1), 12 (T2) and 18 (T3) months

Previous primary outcome measures:
Coping with hearing loss, measured with the Communication Profile for the Hearing Impaired (CPHI) at baseline and after 6 (T1), 12 (T2) and 18 (T3) months

Secondary Outcome(s)

Secondary outcome measures as of 14/11/2018:
1. Personal adjustment to hearing impairment, measured with the Communication Profile for the Hearing Impaired (CPHI), at baseline, and after 6 (T1), 12 (T2) and 18 (T3) months. Personal adjustment is measured using the following three CPHI-subscales: self-acceptance, acceptance of loss, and stress and withdrawal.
2. Self-efficacy of hearing aid use and will be measured by the Basic Handling subscale of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) at baseline, T1, T2 and T3. At baseline it covers the ‘expected self-efficacy’ of the new hearing aid, while T1, T2 and T3 prompts the ‘experienced self-efficacy’. Added 31/01/2017: At T1, T2, and T3, the 5-item subscale Advanced Handling will be additionally administered
3. Actual use of the hearing aid/or use of the 'Alternative Intervention' will be measured with the first item of the International Outcome Inventory – Hearing Aids / International Outcome Inventory – Alternative Interventions questionnaire (IOI-HA/IOI-AI). Hearing aid use/use of the alternative intervention will only be measured at T1, T2 and T3. Furthermore, three questions from the Questionnaire regarding hearing aid usage developed by Laplante-Lévesque and colleagues will be used
4. Efficacy of the hearing aid/alternative intervention will be measured by items of the IOI-HA/IOI-AI questionnaire: benefit (item 2), residual activity limitation (3), satisfaction (4), residual participation restriction (5), impact on others (6) and quality of life (7) of the hearing aid and/or the alternative intervention. In addition to the IOI-AI items, three items of the IOI-HA will be administered in the group of participants who received the Support Program. These are: use (item 1), satisfaction (item 4) and quality of life (item 7). These IOI- items will also only be assessed at T1, T2, and T3
5. Satisfaction with the hearing aid dispensing practice service will be measured by the following question: "How likely is it that you would recommend the service of the hearing aid dispenser practice to other people (family, friends, colleagues)?"
6. Self-reported hearing status will be measured using the following five subscales of the Amsterdam Inventory for Auditory Disability and Handicap (AIADH): Distinction of sounds, Auditory localization, Intelligibility in noise, Intelligibility in quiet, and Detection of sounds. For each item, the A-part inquires about the respondent’s ability to hear in a particular listening situation and will be measured at baseline, T1, T2 and T3. The B-part of each item is only asked in case disability is indicated in the A-part, and inquires about the respondent’s inconvenience of not being able to hear well in that specific situation. The B-part will be measured at T1, T2, and T3 only.
7, Stage of behaviour change will be measured by the University of Rhode Island Change Assessment- for Hearing health behaviour (URICA) and will be measured at baseline, T1, T2 and T3
8. Emotional response to hearing problems will be measured by using five questions that are inspired by the Hearing Handicap and Disability Inventory (as used by Kramer et al. 2005). It will be administered at baseline, T1, T2, and T3.



Secondary outcomes as of 05/03/2018
1. Self-efficacy of hearing aid use and will be measured by the Basic Handling subscale of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) at baseline, T1, T2 and T3. At baseline it covers the ‘expected self-efficacy’ of the new hearing aid, while T1, T2 and T3 prompts the ‘experienced self-efficacy’. Added 31/01/2017: At T1, T2, and T3, the 5-item subscale Advanced Handling will be additionally administered
2. Actual use of the hearing aid/or use of the 'Alternative Intervention' will be measured with the first item of the International Outcome Inventory – Hearing Aids / International Outcome Inventory – Alternative Interventions questionnaire (IOI-HA/IOI-AI). Hearing aid use/use of the alternative intervention will only be measured at T1, T2 and T3. Furthermore, three questions from the Questionnaire regarding hearing aid usage developed by Laplante-Lévesque and colleagues will be used
3. Efficacy of the hearing aid/alternative intervention will be measured by items of the IOI-HA/IOI-AI questionnaire: benefit (item 2), residual activity limitation (3), satisfaction (4), residual participation restriction (5), impact on others (6) and quality of life (7) of the hearing aid and/or the alternative intervention. These IOI- items will also only be assessed at T1, T2, and T3
4. Satisfaction with the hearing aid dispenser’s service will be measured by the Net Promoter Score. It will be measured at baseline, T1, T2 and T3
5. Self-reported hearing status will be measured using the Amsterdam Inventory for Auditory Disability and Handicap (AIADH) and will be measured at baseline, T1, T2 and T3
6, Stage of behaviour change will be measured by the University of Rhode Island Change Assessment- for Hearing health behaviour (URICA) and will be measured at baseline, T1, T2 and T3
7. Emotional response to hearing problems will be measured with the 'emotional response' section from the Hearing Handicap and Disability Inventory at baseline, T1, T2 and T3

Among the communication partners these outcomes will be measured:
1. Third-party disability will be measured with the Significant Other Scale for Hearing Disability (SOS-HEAR) at baseline, T1, T2 and T3
2. Efficacy outcomes of the hearing aid/intervention from the perspective of the significant other will be administered: Use, benefit, residual activity limitation, satisfaction, residual participation restriction, impact on others and quality of life. The 7-item IOI-HA-SO/IOI-AI-SO will be used at T1, T2 and T3

Original secondary outcomes
1. Self-efficacy of hearing aid use and will be measured by the Basic Handling subscale of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) at baseline, T1, T2 and T3. At baseline it covers the ‘expected self-efficacy’ of the new hearing aid, while T1, T2 and T3 prompts the ‘experienced self-efficacy’. Added 31/01/2017: At T1, T2, and T3, the 5-item subscale Advanced Handling will be additionally administered
2. Actual use of the hearing aid/or use of the 'Alternative Intervention' will be measured with the first item of the International Outcome Inventory – Hearing Aids / International Outcome Inventory – Alternative Interventions questionnaire (IOI-HA/IOI-AI). In addition, data-logging within the hearing aid will be used to measure the hearing aid use. Hearing aid use/use of the alternative intervention will only be measured at T1, T2 and T3. Furthermore, three questions from the Questionnaire regarding hearing aid usage developed by Laplante-Lévesque and colleagues will be used
3. Efficacy of the hearing aid/alternative intervention will be measured by items of the IOI-HA/IOI-AI questionnaire: benefit (item 2), residual activity limitation (3), satisfaction (4), residual participation restriction (5), impact on others (6) and quality of life (7) of the hearing aid and/or the alternative intervention. These IOI- items will also only be assessed at T1, T2, and T3
4. Satisfaction with the hearing aid dispenser’s service will be measured by the Net Promoter Score. It will be measured at baseline, T1, T2 and T3
5. Self-reported hearing status will be measured using the Amsterda

Secondary ID(s)

WC2015-027 2015.335

Source(s) of Monetary Support

AudioNova International B.V. (Netherlands)

Ethics review

Status:
Approval date:
Contact:

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]) has reviewed the study and has confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to the study and an official approval of this study by the Medical Ethics Review Committee of VU University Medical Center is not required in this sense (reference number o

Results

• Results available: Yes
• Date Completed: 01/09/2018