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Educational Program for Hearing Aid Users With Internet Support

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01837550
Enrollment
74
Registered
2013-04-23
Start date
2013-04-30
Completion date
2014-06-30
Last updated
2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Impaired

Keywords

audiologic rehabilitation, hearing loss, patient education, patient participation, structured rehabilitation, counseling, Internet

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.

Interventions

BEHAVIORALIntervention 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.

BEHAVIORALControl group

The control group only had access to reading material.

Sponsors

Sodra Alvsborgs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Hearing Handicap Inventory for the Elderly (HHIE)5 weeks, 6 monthsThe 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

MeasureTime frameDescription
International Outcome Inventory for Hearing Aids (IOI-HA)pre-measurementThe 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)5 weeks, 6 monthsThe 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)5 weeks, 6 monthsCSS 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.

Countries

Sweden

Participant flow

Recruitment details

2013-2014; Borås Hospital, Sweden; Alingsås Hospital, Sweden; Skene Hospital, Sweden.

Pre-assignment details

Participants who registered at the website and completed the screening form (n=108) were called for an interview to assess their eligibility; 104 informed an agreement to participate in the study. 14 of them did not fulfill the criteria for the Hearing Handicap Inventory for the Elderly, and 16 chose not to fill out the requested questionnaires.

Participants by arm

ArmCount
Intervention Group
Professional support via Internet 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.
37
Control Group
no professional support 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.
37
Total74

Baseline characteristics

CharacteristicIntervention GroupControl GroupTotal
Age, Continuous61.8 years
STANDARD_DEVIATION 11.9
62.1 years
STANDARD_DEVIATION 11.4
62.0 years
STANDARD_DEVIATION 11.6
Number of Hearing Aids
Binaurally
28 numbers31 numbers59 numbers
Number of Hearing Aids
Monaurally
9 numbers6 numbers15 numbers
Pure-tone average
Left ear
37.8 decibel Hearing Level
STANDARD_DEVIATION 10.5
36.5 decibel Hearing Level
STANDARD_DEVIATION 8.5
37.1 decibel Hearing Level
STANDARD_DEVIATION 9.5
Pure-tone average
Right ear
37.5 decibel Hearing Level
STANDARD_DEVIATION 11.3
38.0 decibel Hearing Level
STANDARD_DEVIATION 8.6
37.8 decibel Hearing Level
STANDARD_DEVIATION 10
Sex: Female, Male
Female
13 Participants17 Participants30 Participants
Sex: Female, Male
Male
24 Participants20 Participants44 Participants
Use of hearing aid7.5 years
STANDARD_DEVIATION 9.6
7.4 years
STANDARD_DEVIATION 6.3
7.5 years
STANDARD_DEVIATION 8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 370 / 37
serious
Total, serious adverse events
0 / 370 / 37

Outcome results

Primary

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.

Time frame: 5 weeks, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupThe Hearing Handicap Inventory for the Elderly (HHIE)Pre-measurement42.0 units on a scaleStandard Deviation 16.9
Intervention GroupThe Hearing Handicap Inventory for the Elderly (HHIE)Directly after-measurement (5 weeks)35.8 units on a scaleStandard Deviation 15.2
Intervention GroupThe Hearing Handicap Inventory for the Elderly (HHIE)6 months-post measurement36.0 units on a scaleStandard Deviation 15.8
Control GroupThe Hearing Handicap Inventory for the Elderly (HHIE)Pre-measurement36.1 units on a scaleStandard Deviation 11.8
Control GroupThe Hearing Handicap Inventory for the Elderly (HHIE)Directly after-measurement (5 weeks)31.3 units on a scaleStandard Deviation 14.3
Control GroupThe Hearing Handicap Inventory for the Elderly (HHIE)6 months-post measurement34.0 units on a scaleStandard Deviation 13.2
p-value: 0.685Mixed Models Analysis
Secondary

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.

Time frame: 5 weeks, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupCommunication Strategies Scale (CSS)Pre-measurement68.1 units on a scaleStandard Deviation 13.6
Intervention GroupCommunication Strategies Scale (CSS)Directly after-measurement (5 weeks)74.7 units on a scaleStandard Deviation 11.1
Intervention GroupCommunication Strategies Scale (CSS)6 months post-measurement70.9 units on a scaleStandard Deviation 10.5
Control GroupCommunication Strategies Scale (CSS)Pre-measurement67.2 units on a scaleStandard Deviation 11.3
Control GroupCommunication Strategies Scale (CSS)Directly after-measurement (5 weeks)68.5 units on a scaleStandard Deviation 12.4
Control GroupCommunication Strategies Scale (CSS)6 months post-measurement66.7 units on a scaleStandard Deviation 11.6
Secondary

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.

Time frame: 5 weeks, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupHospital Anxiety and Depression Scale (HADS)Pre-measurement8.5 units on a scaleStandard Deviation 6.6
Intervention GroupHospital Anxiety and Depression Scale (HADS)Directly after-measurement (5 weeks)7.5 units on a scaleStandard Deviation 6.3
Intervention GroupHospital Anxiety and Depression Scale (HADS)6 months post-measurement4.8 units on a scaleStandard Deviation 4.5
Control GroupHospital Anxiety and Depression Scale (HADS)Pre-measurement7.4 units on a scaleStandard Deviation 4.8
Control GroupHospital Anxiety and Depression Scale (HADS)Directly after-measurement (5 weeks)6.5 units on a scaleStandard Deviation 5.2
Control GroupHospital Anxiety and Depression Scale (HADS)6 months post-measurement6.8 units on a scaleStandard Deviation 5.9
Secondary

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.

Time frame: pre-measurement

Population: The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)3. Remaining activity limitation3.1 units on a scaleStandard Deviation 0.8
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)5. Remaining participation restriction3.8 units on a scaleStandard Deviation 1.1
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)2. Benefit3.8 units on a scaleStandard Deviation 0.9
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)6. Impact on environment3.6 units on a scaleStandard Deviation 0.9
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)4. Satisfaction4.1 units on a scaleStandard Deviation 1.1
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)7. Quality of life3.6 units on a scaleStandard Deviation 0.8
Intervention GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)1. Daily use4.1 units on a scaleStandard Deviation 1.1
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)7. Quality of life3.6 units on a scaleStandard Deviation 1
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)1. Daily use4.4 units on a scaleStandard Deviation 1
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)2. Benefit4.1 units on a scaleStandard Deviation 0.9
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)3. Remaining activity limitation3.1 units on a scaleStandard Deviation 0.8
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)4. Satisfaction4.4 units on a scaleStandard Deviation 0.8
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)5. Remaining participation restriction4.1 units on a scaleStandard Deviation 0.8
Control GroupInternational Outcome Inventory for Hearing Aids (IOI-HA)6. Impact on environment3.9 units on a scaleStandard Deviation 0.9

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026