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| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hear-Talk-Activity audiological rehabilitation program | Experimental | Audiological intervention program |
|
| Control group | No Intervention | Waitlist control program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hear-Talk-Activity audiological program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meei-Fang Lou, Ph.D. | Contact | 886-2-23123456 | 88441 | mfalou@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Meei-Fang Lou, Ph.D. | School of Nursing, College of Medicine, National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40157018 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2024 | |
| Reset | Sep 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2024 | Sep 17, 2024 |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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)
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| baseline, 3th, 6th month |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |