Clinical trial NCT01837550: Educational Program for Hearing Aid Users With Internet Support
Official title: A Randomized, Controlled Trial Evaluating the Short- and Long-term Effects of an Internet-based Aural Rehabilitation Program for Hearing Aid Users Implemented in a General Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impaired
Keywords: audiologic rehabilitation
hearing loss
patient education
patient participation
structured rehabilitation
counseling
Internet
Lead sponsor: Sodra Alvsborgs Hospital
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the short-term effects of complementing an educational program for hearing aid users with Internet support.

Detailed description: Aural rehabilitation aims to improve communication for people with hearing impairment. Education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. Internet as a complement to aural rehabilitation has been tested in different studies with promising results. Though, until now not applied clinically as a part of an aural rehabilitation, focusing on hearing aid users with persistent self- reported hearing problems.

The purpose of this study was to evaluate the effect of an internet-based aural rehabilitation for hearing aid users from a clinical population.

Participants were randomly assigned to an intervention or control group. The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum. The control group only had access to reading material.

The Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression Scale (HADS) and the Communication Strategies Scale (CSS) were used to measure the outcomes of this study; and were recorded before and directly after the intervention as well as 6 months post-intervention.

Eligibility criteria: Inclusion Criteria:

* the hearing aid users to be between 20 and 80 yr of age,
* the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel Hearing Level pure-tone average measured across 500, 1000, and 2000 Hertz),
* the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
* the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of \>20 points (indicative of some residual self-reported hearing problems),
* the hearing aid users to provide informed consent to participate

Exclusion Criteria:

* the hearing aid users who are not fulfilling the conditions to participate

Primary outcomes:
measure: The Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: 5 weeks, 6 months
Secondary outcomes:
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: pre-measurement
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 5 weeks, 6 months
measure: Communication Strategies Scale (CSS)
timeFrame: 5 weeks, 6 months
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: Hearing Clinic, Hearing Organization
state: Vastra Gotalandsregion
Study officials:
affiliation: Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.
name: Gerhard Andersson, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.
name: Thomas Lunner, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malmberg M, Lunner T, Kahari K, Andersson G. Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial. BMJ Open. 2017 Jun 6;7(5):e013047. doi: 10.1136/bmjopen-2016-013047.