Older AdultsNCT05083221
Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults
A study testing Hear-Talk-Activity audiological program in people with Older Adults and Hearing Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults, Hearing Impairment, Nursing
- What is being tested?
- Hear-Talk-Activity audiological program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- severe psychiatric disorders
- acoustic neuroma lead to hearing impairment
- chronic otitis media lead to hearing impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Meei-Fang Lou, PhD, 886-2-23123456 ext. 88441, mfalou@ntu.edu.tw
About this study
Official title: The Effectiveness of an Aural Rehabilitation Program on Communication Abilities, Depression, Loneliness and Quality of Life in Older Adults With Hearing Impairment
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.
Read the 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).
- Conditions
- Older Adults, Hearing Impairment, Nursing
- Being tested
- Hear-Talk-Activity audiological program
- Keywords
- audiological rehabilitation, hearing impairment, quality of life, older adults, communication ability, depression, loneliness
- Medical subject headings
- Hearing Loss, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hear-Talk-Activity audiological programBehavioural
The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.
| Study group | Role | What they receive |
|---|---|---|
| Hear-Talk-Activity audiological rehabilitation program | Experimental | Audiological intervention program Receives: Behavioral: Hear-Talk-Activity audiological program |
| Control group | No intervention | Waitlist control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 3th, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion6 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Meei-Fang Lou, Ph.D., Principal investigator, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083221
- Sponsor's protocol ID
- 202007027RINA
- Status last verified
- Oct 2021
- First submitted
- 13 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40157018
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Aural Rehabilitation Program on Communication Abilities, Depression, Loneliness and Quality of Life in Older Adults With Hearing Impairment
- ClinicalTrials.gov ID
- NCT05083221
- Acronym / sponsor ID
- 202007027RINA
- Conditions
- Older Adults, Hearing Impairment, Nursing
- Keywords
- audiological rehabilitation, hearing impairment, quality of life, older adults, communication ability, depression, loneliness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 6 Jun 2023 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Hear-Talk-Activity audiological rehabilitation program | Experimental | Behavioral: Hear-Talk-Activity audiological programAudiological intervention program |
| Control group | No intervention | –Waitlist control program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- severe psychiatric disorders
- acoustic neuroma lead to hearing impairment
- chronic otitis media lead to hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hear-Talk-Activity audiological programThe participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers. | Behavioural | Hear-Talk-Activity audiological rehabilitation program |
Primary outcome
Change from Baseline the Hearing Handicap Inventory for the Elderly-Screening version at 3 months, and 6 months
Time frame: baseline, 3th, 6th month
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
Time frame: baseline, 3th, 6th month
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
Time frame: baseline, 3th, 6th month
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
Time frame: baseline, 3th, 6th month
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
Time frame: baseline, 3th, 6th month
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 40157018Tseng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meei-Fang Lou, Ph.D. principal investigator
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hear-Talk-Activity audiological program in people with Older Adults and Hearing Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meei-Fang Lou, Ph.D. (886-2-23123456 ext. 88441, mfalou@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline the Hearing Handicap Inventory for the Elderly-Screening version at 3 months, and 6 months (time frame: baseline, 3th, 6th month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.