Educational Program for Hearing Aid Users With Internet Support
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|ClinicalTrials.gov Identifier: NCT01837550|
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : April 25, 2016
Last Update Posted : April 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impaired||Behavioral: Intervention group Behavioral: Control group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|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 Start Date :||April 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
Active Comparator: Control group
no professional support
Behavioral: Intervention 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.
Experimental: Intervention group
Professional support via Internet
Behavioral: Control group
The control group only had access to reading material.
- 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.
- International Outcome Inventory for Hearing Aids (IOI-HA) [ Time Frame: pre-measurement ]The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 5 weeks, 6 months ]The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.
- Communication Strategies Scale (CSS) [ Time Frame: 5 weeks, 6 months ]CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837550
|Hearing Clinic, Hearing Organization|
|Boras, Vastra Gotalandsregion, Sweden, 501 82|
|Principal Investigator:||Gerhard Andersson, Professor||Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.|
|Principal Investigator:||Thomas Lunner, Professor||Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.|