Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults
Primary Purpose
Older Adults, Hearing Impairment, Nursing
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hear-Talk-Activity audiological program
Sponsored by
About this trial
This is an interventional health services research trial for Older Adults focused on measuring audiological rehabilitation, hearing impairment, quality of life, older adults, communication ability, depression, loneliness
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hear-Talk-Activity audiological rehabilitation program
Control group
Arm Description
Audiological intervention program
Waitlist control program
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05083221
First Posted
September 13, 2021
Last Updated
October 17, 2021
Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05083221
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
June 6, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Adults, Hearing Impairment, Nursing
Keywords
audiological rehabilitation, hearing impairment, quality of life, older adults, communication ability, depression, loneliness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hear-Talk-Activity audiological rehabilitation program
Arm Type
Experimental
Arm Description
Audiological intervention program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waitlist control program
Intervention Type
Behavioral
Intervention Name(s)
Hear-Talk-Activity audiological program
Intervention Description
The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.
Primary Outcome Measure Information:
Title
Change from Baseline the Hearing Handicap Inventory for the Elderly-Screening version at 3 months, and 6 months
Description
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
Time Frame
baseline, 3th, 6th month
Title
Change from Baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months
Description
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
Time Frame
baseline, 3th, 6th month
Title
Change from Baseline the short-form UCLA Loneliness Scale-8 item at 3 months, and 6 months
Description
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
Time Frame
baseline, 3th, 6th month
Title
Change from Baseline the Short Form-12 health survey at 3 months, and 6 months
Description
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
Time Frame
baseline, 3th, 6th month
Title
Change from Baseline the International Outcome Inventory for Hearing Aids at 3 months, and 6 months
Description
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
Time Frame
baseline, 3th, 6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meei-Fang Lou, Ph.D.
Phone
886-2-23123456
Ext
88441
Email
mfalou@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meei-Fang Lou, Ph.D.
Organizational Affiliation
School of Nursing, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meei-Fang Lou, PhD
Phone
886-2-23123456
Ext
88441
Email
mfalou@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults
We'll reach out to this number within 24 hrs