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Clinical Trials/NCT05083221
NCT05083221
Unknown
N/A

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

National Taiwan University Hospital1 site in 1 country96 target enrollmentSeptember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Older Adults
Sponsor
National Taiwan University Hospital
Enrollment
96
Locations
1
Primary Endpoint
Change from Baseline the International Outcome Inventory for Hearing Aids at 3 months, and 6 months
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
June 6, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from Baseline the International Outcome Inventory for Hearing Aids at 3 months, and 6 months

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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