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

October 17, 2021 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Meei-Fang Lou, Ph.D.
  • Phone Number: 88441 886-2-23123456
  • Email: mfalou@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hear-Talk-Activity audiological rehabilitation program
Audiological intervention program
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.
No Intervention: Control group
Waitlist control program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
baseline, 3th, 6th month
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
baseline, 3th, 6th month
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
baseline, 3th, 6th month
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
baseline, 3th, 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health and Welfare, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meei-Fang Lou, Ph.D., School of Nursing, College of Medicine, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202007027RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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