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Educational Program for Hearing Aid Users With Internet Support

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Milijana Malmberg, Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier:
NCT01837550
First received: April 18, 2013
Last updated: March 22, 2016
Last verified: March 2016
  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 Evaluating the Short- and Long-term Effects of an Internet-based Aural Rehabilitation Program for Hearing Aid Users Implemented in a General Clinical Practice

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


Enrollment: 74
Study Start Date: April 2013
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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

Locations
Sweden
Hearing Clinic, Hearing Organization
Boras, Vastra Gotalandsregion, Sweden, 501 82
Sponsors and Collaborators
Sodra Alvsborgs Hospital
Investigators
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.
  More Information

Responsible Party: Milijana Malmberg, 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
Results First Received: January 12, 2016
Last Updated: March 22, 2016
Health Authority: Sweden: Regional Ethical Review Board
Individual Participant Data  
Plan to Share IPD: No

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 September 28, 2016