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

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National Taiwan University

Status

Unknown

Conditions

Older Adults
Nursing
Hearing Impairment

Treatments

Behavioral: Hear-Talk-Activity audiological program

Study type

Interventional

Funder types

Other

Identifiers

NCT05083221
202007027RINA

Details and patient eligibility

About

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.

Full 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).

Enrollment

96 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

96 participants in 2 patient groups

Hear-Talk-Activity audiological rehabilitation program
Experimental group
Description:
Audiological intervention program
Treatment:
Behavioral: Hear-Talk-Activity audiological program
Control group
No Intervention group
Description:
Waitlist control program

Trial contacts and locations

1

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Central trial contact

Meei-Fang Lou, Ph.D.

Data sourced from clinicaltrials.gov

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