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

Not Applicable

• Conditions: Hearing Impairment; Older Adults; Nursing
• Interventions: Behavioral: Hear-Talk-Activity audiological program

• Registration Number: NCT05083221
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-13
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-17
• Last Update Submitted: 2021-10-17
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Primary Completion: 2023-02-28
• Study Completion: 2023-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

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Exclusion Criteria

• severe psychiatric disorders
• acoustic neuroma lead to hearing impairment
• chronic otitis media lead to hearing impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hear-Talk-Activity audiological rehabilitation program	Hear-Talk-Activity audiological program	Audiological intervention program

Primary Outcome Measures

Name	Time	Method
Change from Baseline the International Outcome Inventory for Hearing Aids at 3 months, and 6 months	baseline, 3th, 6th month	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
Change from Baseline the Hearing Handicap Inventory for the Elderly-Screening version at 3 months, and 6 months	baseline, 3th, 6th month	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
Change from Baseline the short-form UCLA Loneliness Scale-8 item at 3 months, and 6 months	baseline, 3th, 6th month	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
Change from Baseline the Short Form-12 health survey at 3 months, and 6 months	baseline, 3th, 6th month	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
Change from Baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months	baseline, 3th, 6th month	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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan