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

NCT ID: NCT05083221

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-06-06

Brief Summary

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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

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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).

Conditions

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Older Adults Hearing Impairment Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hear-Talk-Activity audiological rehabilitation program

Audiological intervention program

Group Type EXPERIMENTAL

Hear-Talk-Activity audiological program

Intervention Type BEHAVIORAL

The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.

Control group

Waitlist control program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meei-Fang Lou, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, College of Medicine, National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Meei-Fang Lou, Ph.D.

Role: CONTACT

[email protected]
886-2-23123456 ext. 88441

Facility Contacts

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Meei-Fang Lou, PhD

Role: primary

[email protected]
886-2-23123456 ext. 88441

References

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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.

Reference Type DERIVED
PMID: 40157018 (View on PubMed)

Other Identifiers

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202007027RINA

Identifier Type: -

Identifier Source: org_study_id