Educational Program for Hearing Aid Users With Internet Support

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Sodra Alvsborgs Hospital
Sponsor:
Information provided by (Responsible Party):
Milijana Lundberg, Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier:
NCT01837550
First received: April 18, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Hearing Impaired
Behavioral: Intervention group
Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Trial of the Short-term Effects of Complementing an Educational Program for Hearing Aid Users With Internet Support

Resource links provided by NLM:


Further study details as provided by Sodra Alvsborgs Hospital:

Primary Outcome Measures:
  • The Hearing Handicap Inventory for the Elderly (HHIE) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The HHIE measures the experience of hearing loss in older people by focusing on the psychosocial and emotional effects of hearing loss.


Secondary Outcome Measures:
  • International Outcome Inventory for Hearing Aids (IOI-HA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The HADS measures anxiety and depression.


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
no professional support
Behavioral: Intervention group
Experimental: Intervention group
Professional support via Internet
Behavioral: Control group

Detailed 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 Hospital Anxiety and Depression Scale, and the International Outcome Inventory for Hearing Aids will be used to measure the outcomes of this study.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the hearing aid users to be between 20 and 60 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837550

Contacts
Contact: Milijana Lundberg, PhD student +46 703 80 36 63 milijana.lundberg@vgregion.se

Locations
Sweden
Hearing Clinic, Hearing and Deafness Organization Recruiting
Borås, Västra Götalandsregion, Sweden, 501 82
Contact: Milijana Lundberg, PhD student    +46 703 80 3663    milijana.lundberg@vgregion.se   
Sponsors and Collaborators
Sodra Alvsborgs Hospital
Investigators
Principal Investigator: Gerhard Andersson, Professor Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linköping 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, Linko¨ping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.
  More Information

No publications provided

Responsible Party: Milijana Lundberg, PhD student, Principal Investigator, Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier: NCT01837550     History of Changes
Other Study ID Numbers: HörNet VGR
Study First Received: April 18, 2013
Last Updated: April 25, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sodra Alvsborgs Hospital:
audiologic rehabilitation
hearing loss
patient education
patient participation
structured rehabilitation
counseling
Internet

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014