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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05083221
Collaborator
Ministry of Health and Welfare, Taiwan (Other)
96
1
2
21.1
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hear-Talk-Activity audiological program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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)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 (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
The Effectiveness of an Aural Rehabilitation Program on Communication Abilities, Depression, Loneliness and Quality of Life in Older Adults With Hearing Impairment
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Jun 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hear-Talk-Activity audiological rehabilitation program

Audiological intervention program

Behavioral: Hear-Talk-Activity audiological program
The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.

No Intervention: Control group

Waitlist control program

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital
  • Ministry of Health and Welfare, Taiwan

Investigators

  • Principal Investigator: Meei-Fang Lou, Ph.D., School of Nursing, College of Medicine, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05083221
Other Study ID Numbers:
  • 202007027RINA
First Posted:
Oct 19, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021