Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults

Study Overview
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Brief Summary
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Hearing impairment in older adults is becoming a common health problem as the population ages. The impact of hearing impairment in older adults includes not only physical function and cognitive performance, but also depression, loneliness and social isolation, as well as having a negative impact on quality of life and financial status. Therefore, an audiological rehabilitation program intervention is recommended. The purposes of this study are to examine the effects of an audiological rehabilitation program (Hear-Talk-Activity audiological rehabilitation program) intervention on communication abilities, depression, loneliness and quality of life outcomes in older adults with hearing impairment. The single-blind, randomized control trial will include older adults aged 65 years or older with hearing impairment and aid user. Participants will be randomized to either intervention groups or control groups.

Detailed Description
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The study will be an experimental design featuring repeated measures, with data collected from a pretest, a posttest and a follow-up test. An estimated total of 96 participants will be randomly assigned to experimental and control groups. The experimental group will participate in a 10-week aural rehabilitation program (Hear-Talk-Activity audiological rehabilitation program), including provide information, hearing aids and assistive listening devices, communication strategies and skills, personal coping and adjustment, psychosocial support and stress management, consisting of 60-minute sessions once per week, while the control group will be put on a waiting-list group. Each group will be assessed of the outcomes at 3 time points: baseline (T0), three months following the intervention (T1) and again at six months following the intervention (T2). The investigators will use the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S), the 10-item version of the Center for Epidemiological Studies Depression Scale (10-item CES-D), the short-form University of California, Los Angeles (UCLA) Loneliness Scale-8 item (ULS-8) and the Short Form-12 health survey (SF-12) as the outcome indicators. The principle of intention-to-treat (ITT) analysis will be used, and the result will be analyzed mainly by generalized estimating equation (GEE).

Official Title
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The Effectiveness of an Aural Rehabilitation Program on Communication Abilities, Depression, Loneliness and Quality of Life in Older Adults With Hearing Impairment

Conditions
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Older Adults, Hearing Impairment, Nursing

Intervention / Treatment
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* Behavioral: Hear-Talk-Activity audiological program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being 65 or older Pure-Tone Average (PTA) more than 40 decibel (dB) Hearing Level (HL) and aid users less than half a year living in the community having normal cognitive articulate in the Mandarin Chinese language signing a consent form to participate Exclusion Criteria: severe psychiatric disorders acoustic neuroma lead to hearing impairment chronic otitis media lead to hearing impairment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this single-blind, randomized controlled trial, older adults aged 65 years or older with hearing impairment will be randomized into either the intervention group (Hear-Talk-Activity intervention group) or the control group (waitlist control group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hear-Talk-Activity audiological rehabilitation program<br>Audiological intervention program | Behavioral: Hear-Talk-Activity audiological program<br>* The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.<br>|
| No Intervention: Control group<br>Waitlist control program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline the Hearing Handicap Inventory for the Elderly-Screening version at 3 months, and 6 months | A score of participants in baseline communication abilities as assessed by the Hearing Handicap Inventory for the Elderly-Screening version. The overall score ranging from 0 to 40, which higher scores indicating poorer communication abilities | baseline, 3th, 6th month | 
| Change from Baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months | A score of participants in baseline depression as assessed by the 10-item version of the Center for Epidemiological Studies Depression Scale. The overall score ranging from 0 to 30, which higher scores indicating severe depression | baseline, 3th, 6th month | 
| Change from Baseline the short-form UCLA Loneliness Scale-8 item at 3 months, and 6 months | A score of participants in baseline loneliness as assessed by the short-form UCLA Loneliness Scale-8 item. The overall score ranging from 8 to 32, which higher scores indicating severe loneliness | baseline, 3th, 6th month | 
| Change from Baseline the Short Form-12 health survey at 3 months, and 6 months | A score of participants in baseline quality of life as assessed by the Short Form-12 health survey. The overall score ranging from 0 to 100, which higher scores indicating better quality of life | baseline, 3th, 6th month | 
| Change from Baseline the International Outcome Inventory for Hearing Aids at 3 months, and 6 months | A score of participants in baseline communication abilities and aids satisfaction as assessed by the International Outcome Inventory for Hearing Aids. The overall score ranging from 7 to 35, which higher scores indicating better communication abilities and aid satisfaction | baseline, 3th, 6th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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audiological rehabilitation, hearing impairment, quality of life, older adults, communication ability, depression, loneliness