Age-related Hearing ImpairmentK-HEARS MCINCT06068933
Hearing Health for Korean American Older Adults With Mild Cognitive Impairment
A study testing K-HEARS Intervention and K-HEARS Sound Amplifier Intervention in people with Age-related Hearing Impairment and Personal Communication, run by Johns Hopkins University at 1 site in United States.
Trial summary
The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, affordable, and accessible hearing care intervention tailored to the needs of community-dwelling Korean American (KA) older adults with mild cognitive impairment (MCI) and their care… Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Hearing Impairment, Personal Communication, Mild Cognitive Impairment
- What is being tested?
- K-HEARS Intervention and K-HEARS Sound Amplifier Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 27 Nov 2024
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participant exclusion criteria
- Residence in an assisted living facility (ALF) or nursing home (NH)
- Medical contraindication to use of amplification device (e.g., draining ear)
- Currently using a hearing aid or listening device
- Care partner exclusion criteria
- Individuals who do not fulfill inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot
The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, affordable, and accessible hearing care intervention tailored to the needs of community-dwelling Korean American (KA) older adults with mild cognitive impairment (MCI) and their care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation through a randomized controlled pilot study. Each dyad will consist of the study participant and their care partner.
Read the detailed description
The study consists of three phases: 1) Phase 1: development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial 2) Phase 2A: randomized, controlled pilot study with study participants randomized to an immediate treatment group, versus a 6-month delayed treatment group of an intervention specific for individuals with MCI, 3) Phase 2B: a non-randomized pragmatic-focused trial of community-dwelling older KAs with hearing loss but without MCI, and 4) Phase 3: qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews.
- Being tested
- K-HEARS Intervention, K-HEARS Sound Amplifier Intervention
- Medical subject headings
- Communication, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-HEARS InterventionBehavioural
Tailored aural rehabilitation for participant and care partner
K-HEARS Sound Amplifier InterventionDevice
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2A -MCI Pilot Trial Immediate Treatment Group | Experimental | Immediate treatment with K-HEARS intervention Receives: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention |
| Phase 2A -MCI Pilot Trial Delayed Treatment Group | Placebo comparator | 6-month delayed treatment with K-HEARS intervention Receives: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention |
| Phase 2B -KA Older Adult Focused Trial (non-randomized) | Other | Immediate treatment with K-HEARS intervention Receives: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Secondary outcomes (3)
Revised UCLA Loneliness Scale
Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.
Score ranges:
20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness.
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Short Form-12 (SF-12) Mental Component Score
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Score ranges from 0-100 with higher scores indicating better mental health functioning.
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Social Network size Measured by Lubben Social Network Index
Measures social network size for both family and friends and also the frequency of interaction with them. Higher scores indicate higher level of social engagement. Score range (0-30).
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start12 Dec 2023
- Primary completion8 Aug 2024
- Study completion27 Nov 2024
Why it stopped: This study is being terminated due to insufficient participant recruitment within the projected timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in Phase 2-A MCI Focused Trial will be randomized into a two arms: immediate intervention and delayed intervention. Participants in Phase 2-B KA Older Adult Focused Trial will not be randomized.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Hae-Ra Han, PhD, RN, Principal investigator, JHU School Of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068933
- Sponsor's protocol ID
- IRB00249500
- Other IDs
- R56DC019686
- Acronym
- K-HEARS MCI
- Status last verified
- Apr 2025
- First submitted
- 29 Sep 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot
- ClinicalTrials.gov ID
- NCT06068933
- Acronym / sponsor ID
- K-HEARS MCI / IRB00249500
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is being terminated due to insufficient participant recruitment within the projected timeframe
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 5 Oct 2023 (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.
The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, affordable, and accessible hearing care intervention tailored to the needs of community-dwelling Korean American (KA) older adults with mild cognitive impairment (MCI) and their care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation through a randomized controlled pilot study. Each dyad will consist of the study participant and their care partner.
Detailed description
The study consists of three phases: 1) Phase 1: development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial 2) Phase 2A: randomized, controlled pilot study with study participants randomized to an immediate treatment group, versus a 6-month delayed treatment group of an intervention specific for individuals with MCI, 3) Phase 2B: a non-randomized pragmatic-focused trial of community-dwelling older KAs with hearing loss but without MCI, and 4) Phase 3: qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants in Phase 2-A MCI Focused Trial will be randomized into a two arms: immediate intervention and delayed intervention. Participants in Phase 2-B KA Older Adult Focused Trial will not be randomized.
| Arm | Type | Receives |
|---|---|---|
| Phase 2A -MCI Pilot Trial Immediate Treatment Group | Experimental | Behavioral: K-HEARS Intervention, Device: K-HEARS Sound Amplifier InterventionImmediate treatment with K-HEARS intervention |
| Phase 2A -MCI Pilot Trial Delayed Treatment Group | Placebo comparator | Behavioral: K-HEARS Intervention, Device: K-HEARS Sound Amplifier Intervention6-month delayed treatment with K-HEARS intervention |
| Phase 2B -KA Older Adult Focused Trial (non-randomized) | Other | Behavioral: K-HEARS Intervention, Device: K-HEARS Sound Amplifier InterventionImmediate treatment with K-HEARS intervention |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Participant exclusion criteria
- Residence in an assisted living facility (ALF) or nursing home (NH)
- Medical contraindication to use of amplification device (e.g., draining ear)
- Currently using a hearing aid or listening device
- Care partner exclusion criteria
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 |
|---|---|---|
| K-HEARS InterventionTailored aural rehabilitation for participant and care partner | Behavioural | Phase 2A -MCI Pilot Trial Delayed Treatment Group, Phase 2A -MCI Pilot Trial Immediate Treatment Group, Phase 2B -KA Older Adult Focused Trial (non-randomized) |
| K-HEARS Sound Amplifier InterventionTailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | Device | Phase 2A -MCI Pilot Trial Delayed Treatment Group, Phase 2A -MCI Pilot Trial Immediate Treatment Group, Phase 2B -KA Older Adult Focused Trial (non-randomized) |
Primary outcome
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
3 secondary outcomes
Revised UCLA Loneliness Scale
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Short Form-12 (SF-12) Mental Component Score
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Social Network size Measured by Lubben Social Network Index
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Results and safety
The study was stopped early (reason given: This study is being terminated due to insufficient participant recruitment within the projected timeframe). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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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.
Hae-Ra Han, PhD, RN principal investigator
JHU School Of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K-HEARS Intervention and K-HEARS Sound Amplifier Intervention in people with Age-related Hearing Impairment and Personal Communication, run by Johns Hopkins University at 1 site in United States.
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 0 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Apr 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: This study is being terminated due to insufficient participant recruitment within the projected timeframe). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Handicap Inventory for the Elderly (HHIE-S) score (time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.