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


- candidate number22815
- NTR NumberNTR5427
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2015
- Secondary IDsWC2015-027 2015.335
- Public TitleA study on the effectiveness of a support programme (SUPR) for adult hearing aid users
- Scientific TitleAddition of a SUpport PRogramme (SUPR) to usual hearing aid care – Effectiveness in adult hearing aid users
- ACRONYM
- hypothesisTo study the effect of the support programme (SUPR) in hearing impaired (50+) hearing aid users and their communication partners. To estimate the effectiveness of solely one element of the support programme, i.e., the practical support book including exercises (see also ‘Statistical Analysis’).
- Healt Condition(s) or Problem(s) studiedHearing loss, Support
- Inclusion criteriaParticipants:
- are at least 50 years old
- have the intention to take up a new hearing aid on one or both ears.
- have sufficient understanding of the Dutch language (speaking, writing, reading).
- have access to a computer with an internet connection for the total duration of the study.
- Exclusion criteriaClients:
- who also receive care at a specialized audiological centre, since this mostly involves people with complex hearing disabilities. The specialized care that is provided in these centres may overlap and/ or interfere with that of the support programme.
- who receive a hearing aid primarily to suppress tinnitus complaints. For these individuals the focus of the rehabilitation is not on restoring communication per se. As such, they are not part of the target group of the support programme.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2015
- planned closingdate1-mei-2019
- Target number of participants1125
- InterventionsThe support programme is designed to help hearing impaired individuals use their hearing aid effectively and to improve successful coping strategies. All participants, including the ones assigned to the control group, are asked to assign a communication partner; a person who has regular contact with the participant. The communication partner plays an important role in enhancing the motivation of the participant. Hearing impaired individuals who are assigned to the SPpsb group, receive the Practical Support Book, including practical information, advice and exercises to do at home during the trial period. The primary aim of the practical support book is to improve familiarity with using the hearing aid. Participants who are assigned to the SPstandard group will be provided with the complete support programme for a period of six months (two month trial period and four months afterwards). It consists of the Practical Support Book and the following components offered by email:
- Contact with Schoonenberg Hoorcomfort, in order to support the user during the first and most crucial trial period of the hearing aid.
- Training modules including:
o Instruction videos with practical information on how to use and maintain a hearing aid.
o The educational programme “Horen en Gehoord Worden: Hoe kan het beter”, developed by Kramer et al. (2005). It comprises five short films regarding difficulties experienced by hearing impaired elderly in everyday life situations. How to improve communication by using certain communication strategies is shown.
- Testimonials by hearing impaired peers, in order to increase acceptation of hearing impairment. In these short films peer hearing aid users share their experiences.
- Primary outcomeThe primary outcome concerns coping with the hearing loss.
- Secondary outcomeSecondary outcomes concern: self-efficacy of hearing aid use, actual use of the hearing aid, satisfaction with the hearing aid dispenser’s service, hearing disability, stage of behaviour change and emotional response.
- TimepointsBaseline
Hearing impaired participant will answer questions about:
Coping with the hearing impairment (CPHI), Expected self-efficacy hearing aid use (MARS-HA), Satisfaction with the hearing aid dispenser (NPS), Self-reported hearing status (AIAHD), Stage of behaviour change (URICA-HA), Emotional response (HHDI)
Communication partner will answer questions about:
Third party disability (SOS-HEAR)

T6
Hearing impaired participant will answer questions about:
Coping with the hearing impairment (CPHI), Experienced self-efficacy hearing aid use (MARS-HA), Several outcomes of the hearing aid/alternative intervention (IOI-HA/IOI-AI), Satisfaction with the hearing aid dispenser (NPS), Self-reported hearing status (AIAHD), Stage of behaviour change (URICA-HA), Emotional response (HHDI)
Communication partner will answer questions about:
Third party disability (SOS-HEAR), Several outcomes of the hearing aid/intervention from the perspective of the significant other (IOI-HA-SO/IOI-AI-SO).

T12
Hearing impaired participant will answer questions about:
Coping with the hearing impairment (CPHI), Experienced self-efficacy hearing aid use (MARS-HA), Several outcomes of the hearing aid/alternative intervention (IOI-HA/IOI-AI), Satisfaction with the hearing aid dispenser (NPS), Self-reported hearing status (AIAHD), Stage of behaviour change (URICA-HA), Emotional response (HHDI)
Communication partner will answer questions about:
Third party disability (SOS-HEAR), Several outcomes of the hearing aid/intervention from the perspective of the significant other (IOI-HA-SO/IOI-AI-SO).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Bregje van der Wouden
- CONTACT for SCIENTIFIC QUERIES Bregje van der Wouden
- Sponsor/Initiator VU University Medical Center Department of Otolaryngology
- Funding
(Source(s) of Monetary or Material Support)
AudioNova/Schoonenberg
- Publications
- Brief summaryBackground
Usual hearing health care is mostly restricted to audiologic assessment and hearing aid fitting. There is growing evidence showing that to increase a hearing impaired individual’s communication in daily life, more than hearing aid fitting alone is needed. Training of communication strategies is an example of an intervention that may improve a person’s communication in daily life. Recently, an (online) audiologic rehabilitation support programme (SUPR) was re-developed in collaboration with hearing care professionals. The support programme follows a holistic approach. Main elements are an instruction book including exercises, frequent contact by email with a hearing expert, training modules covering short films with instructions for daily life situations and testimonials consisting of experiences from other hearing aid users.

Objectives The first aim of this project is to study the effectiveness of the support programme (SUPR) in hearing impaired (50+) hearing aid users and their communication partners. The following outcomes will be considered: coping (primary outcome), self-efficacy in using the hearing aid, actual use of the hearing aid, satisfaction with the hearing care professional service, hearing disability, and stage of behaviour change (secondary outcomes). The second aim is to study the effectiveness of solely one element of the support programme, i.e., the instruction book including exercises.

Methods In this randomized controlled trial (RCT), approximately 1000 hearing aid dispenser customers will be included at baseline. Participants in the control group will receive care as usual and participants in the intervention group will receive either the support programme, or only the instruction book. Measurements will be performed at baseline, after 6 months and after 12 months (long-term effect).
- Main changes (audit trail)
- RECORD31-aug-2015 - 4-nov-2015


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