Clinical trial NCT05083221: Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults
Official title: The Effectiveness of an Aural Rehabilitation Program on Communication Abilities, Depression, Loneliness and Quality of Life in Older Adults With Hearing Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Older Adults
Hearing Impairment
Nursing
Keywords: audiological rehabilitation
hearing impairment
quality of life
older adults
communication ability
depression
loneliness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2021-10-19
Enrollment: 96
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Change from Baseline the Hearing Handicap Inventory for the Elderly-Screening version at 3 months, and 6 months
timeFrame: baseline, 3th, 6th month
measure: Change from Baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months
timeFrame: baseline, 3th, 6th month
measure: Change from Baseline the short-form UCLA Loneliness Scale-8 item at 3 months, and 6 months
timeFrame: baseline, 3th, 6th month
measure: Change from Baseline the Short Form-12 health survey at 3 months, and 6 months
timeFrame: baseline, 3th, 6th month
measure: Change from Baseline the International Outcome Inventory for Hearing Aids at 3 months, and 6 months
timeFrame: baseline, 3th, 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Meei-Fang Lou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: