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Phase 2A -MCI Pilot Trial Immediate Treatment Group for Personal Communication (K-HEARS MCI Trial)

N/A

Recruiting

Led By Hae-Ra Han, PhD, RN

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Age ≥ 60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group)

Awards & highlights

K-HEARS MCI Trial Summary

This trial aims to create and test a hearing care program for older Korean American adults with mild cognitive impairment and their caregivers. The program will include a low-cost hearing device and rehabilitation. A pilot study will

Who is the study for?

This trial is for Korean American adults over 60 with mild cognitive impairment and hearing loss, who can read and speak Korean. They must not be using a hearing aid but have a care partner willing to join the study. Participants should also be on stable medication regimens.Check my eligibility

What is being tested?

The K-HEARS intervention being tested includes an affordable sound amplifier device and hearing rehabilitation tailored for first-generation Korean American older adults with MCI. The study will assess its feasibility, acceptability, and preliminary effectiveness through a randomized pilot study.See study design

What are the potential side effects?

Since this trial involves non-invasive interventions like sound amplifiers and rehabilitation exercises, side effects are minimal but may include discomfort from wearing the device or frustration if difficulties in communication persist.

K-HEARS MCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am 60 years old or older.

K-HEARS MCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hearing Handicap Inventory for the Elderly (HHIE-S) score

Secondary outcome measures

Revised UCLA Loneliness Scale

Short Form-12 (SF-12) Mental Component Score

Social Network size Measured by Lubben Social Network Index

K-HEARS MCI Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 2B -KA Older Adult Focused Trial (non-randomized)Experimental Treatment2 Interventions

Immediate treatment with K-HEARS intervention

Group II: Phase 2A -MCI Pilot Trial Immediate Treatment GroupExperimental Treatment2 Interventions

Immediate treatment with K-HEARS intervention

Group III: Phase 2A -MCI Pilot Trial Delayed Treatment GroupPlacebo Group2 Interventions

6-month delayed treatment with K-HEARS intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,447 Total Patients Enrolled

2 Trials studying Personal Communication

166 Patients Enrolled for Personal Communication

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,421 Total Patients Enrolled

1 Trials studying Personal Communication

151 Patients Enrolled for Personal Communication

Hae-Ra Han, PhD, RNPrincipal InvestigatorJHU School Of Nursing

3 Previous Clinical Trials

347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently open for enrollment?

"Indeed, the details on clinicaltrials.gov indicate that this trial is actively seeking eligible participants. The initial posting took place on December 12th, 2023, and the most recent update occurred on December 21st, 2023. The study aims to enroll a total of 50 individuals from a single site."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting was on December 12th, 2023 and the most recent update occurred on December 21st, 2023. This study aims to enroll a total of 50 individuals from one specific location."

Answered by AI

Are individuals aged 70 and above eligible to participate in this trial?

"To participate in this trial, individuals must be within the age range of 60 to 100. Notably, there are a total of 84 trials available for patients under the age of 18 and 714 trials catered specifically for participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment

2023. "K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068933.

All > Mild Cognitive Impairment