Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults
The Effectiveness of an Aural Rehabilitation Program on Communication Abilities, Depression, Loneliness and Quality of Life in Older Adults With Hearing Impairment
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2023
CompletedOctober 19, 2021
October 1, 2021
1.5 years
September 13, 2021
October 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Hear-Talk-Activity audiological rehabilitation program
EXPERIMENTALAudiological intervention program
Control group
NO INTERVENTIONWaitlist control program
Interventions
The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe psychiatric disorders
- acoustic neuroma lead to hearing impairment
- chronic otitis media lead to hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
Related Publications (1)
Tseng YC, Chang NT, Liu SH, Gau BS, Liu TC, Lou MF. Effects on health outcomes following a nurse-led hearing loss management intervention designed for older adults: A randomized controlled trial. Int J Nurs Stud. 2025 Jun;166:105050. doi: 10.1016/j.ijnurstu.2025.105050. Epub 2025 Mar 11.
PMID: 40157018DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meei-Fang Lou, Ph.D.
School of Nursing, College of Medicine, National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 19, 2021
Study Start
September 1, 2021
Primary Completion
February 28, 2023
Study Completion
June 6, 2023
Last Updated
October 19, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share