Educational Program for Hearing Aid Users With Internet Support

Hearing Impaired Clinical Trial

Official title:

A Randomized, Controlled Trial of the Short-term Effects of Complementing an Educational Program for Hearing Aid Users With Internet Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837550
• Other study ID #: HörNet VGR
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: September 12, 2014
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: Sodra Alvsborgs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Audiologic 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 audiological rehabilitation has been tested in different studies with promising results. Though, until now not applied clinically as a part of an audiological rehabilitation, focused on hearing aid users with persistent self- reported activity limitation and participation restriction.

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

Hearing aid users will randomly be assigned to an intervention group or a control group. The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet. The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.

The Hearing Handicap Inventory for the Elderly, the Communication Strategies Scale, the Hospital Anxiety and Depression Scale, and the International Outcome Inventory for Hearing Aids will be used to measure the outcomes of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 dB HL pure-tone average measured across 500, 1000, and 2000 Hz),

• 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 HHIE score of >20 points (indicative of some residual self-reported hearing handicap),

• the hearing aid users to provide informed consent to participate

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired
• Hearing Loss

Intervention

Behavioral:
• Intervention group
The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
• Control group
The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.

Locations

Country	Name	City	State
Sweden	Hearing Clinic, Hearing and Deafness Organization	Borås	Västra Götalandsregion

Sponsors (1)

Lead Sponsor	Collaborator
Sodra Alvsborgs Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hearing Handicap Inventory for the Elderly (HHIE)	The HHIE measures the experience of hearing loss in older people by focusing on the psychosocial and emotional effects of hearing loss.	6 weeks	No
Secondary	International Outcome Inventory for Hearing Aids (IOI-HA)	The IOI-HA measures hearing aid outcomes. This questionnaire includes seven questions, each highlighting a specific dimension of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life.	6 weeks	No
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS measures anxiety and depression.	6 weeks	No
Secondary	Communication Strategies Scale (CSS)	The CSS measures communication strategies.	6 weeks	No