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Clinical Trials/NCT01837550
NCT01837550
Completed
N/A

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

Sodra Alvsborgs Hospital1 site in 1 country74 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Impaired
Sponsor
Sodra Alvsborgs Hospital
Enrollment
74
Locations
1
Primary Endpoint
The Hearing Handicap Inventory for the Elderly (HHIE)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sodra Alvsborgs Hospital
Responsible Party
Principal Investigator
Principal Investigator

Milijana Malmberg

PhD student, Principal Investigator

Sodra Alvsborgs Hospital

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

Outcomes

Primary Outcomes

The Hearing Handicap Inventory for the Elderly (HHIE)

Time Frame: 5 weeks, 6 months

The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.

Secondary Outcomes

  • Hospital Anxiety and Depression Scale (HADS)(5 weeks, 6 months)
  • Communication Strategies Scale (CSS)(5 weeks, 6 months)
  • International Outcome Inventory for Hearing Aids (IOI-HA)(pre-measurement)

Study Sites (1)

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