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

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083221
• Other study ID #: 202007027RINA
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 6, 2023

Study information

• Verified date: October 2021
• Source: National Taiwan University Hospital
• Contact: Meei-Fang Lou, Ph.D.
• Phone: 886-2-23123456
• Email: mfalou[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 6, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss
• Nursing
• Older Adults

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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