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Educational Program for Hearing Aid Users With Internet Support

Primary Purpose

Hearing Impaired

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
Sodra Alvsborgs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Impaired focused on measuring audiologic rehabilitation, hearing loss, patient education, patient participation, structured rehabilitation, counseling, Internet

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hearing Clinic, Hearing Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

no professional support

Professional support via Internet

Outcomes

Primary Outcome Measures

The Hearing Handicap Inventory for the Elderly (HHIE)
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)
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)
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)
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.

Full Information

First Posted
April 18, 2013
Last Updated
March 22, 2016
Sponsor
Sodra Alvsborgs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01837550
Brief Title
Educational Program for Hearing Aid Users With Internet Support
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sodra Alvsborgs Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired
Keywords
audiologic rehabilitation, hearing loss, patient education, patient participation, structured rehabilitation, counseling, Internet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
no professional support
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Professional support via Internet
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
The control group only had access to reading material.
Primary Outcome Measure Information:
Title
The Hearing Handicap Inventory for the Elderly (HHIE)
Description
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.
Time Frame
5 weeks, 6 months
Secondary Outcome Measure Information:
Title
International Outcome Inventory for Hearing Aids (IOI-HA)
Description
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.
Time Frame
pre-measurement
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
5 weeks, 6 months
Title
Communication Strategies Scale (CSS)
Description
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.
Time Frame
5 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Lunner, Professor
Organizational Affiliation
Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hearing Clinic, Hearing Organization
City
Boras
State/Province
Vastra Gotalandsregion
ZIP/Postal Code
501 82
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28592571
Citation
Malmberg M, Lunner T, Kahari K, Andersson G. Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial. BMJ Open. 2017 Jun 6;7(5):e013047. doi: 10.1136/bmjopen-2016-013047.
Results Reference
derived

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Educational Program for Hearing Aid Users With Internet Support

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