K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Hearing Handicap Inventory for the Elderly (HHIE-S) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PARTICIPANT INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial
- •Age ≥ 60 years
- •Self-identified as first-generation Korean American
- •Self-reported ability to read and speak Korean
- •Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz > 25 decibel hearing loss in better hearing ear
- •Mild cognitive impairment (CDR=0.5 and/or Korean Montreal Cognitive Assessment (MoCA-K) <23)
- •Report not currently using a hearing aid
- •Has a care partner able to participate in the study
- •Stable medication regimen. Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms
- •PARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:
- •Age ≥ 60 years
- •Self-identified as first-generation Korean American
- •Self-reported ability to read and speak Korean
- •Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz >= 35 decibel Hearing Loss in better hearing ear
- •Report not currently using a hearing aid
- •Has a care partner able to participate in the study
- •CARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)
- •Age 18 years or older
- •Able to read and speak Korean
- •Lives in the same household with the participant or has at least daily interactions
- •Aural-oral verbal communication as primary communication modality
- •Able to accompany participant to all study visits
排除标准
- •(same for both Phase 2A and 2B)
- •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
研究组 & 干预措施
Phase 2A -MCI Pilot Trial Delayed Treatment Group
6-month delayed treatment with K-HEARS intervention
干预措施: K-HEARS Intervention (Behavioral)
Phase 2A -MCI Pilot Trial Delayed Treatment Group
6-month delayed treatment with K-HEARS intervention
干预措施: K-HEARS Sound Amplifier Intervention (Device)
Phase 2A -MCI Pilot Trial Immediate Treatment Group
Immediate treatment with K-HEARS intervention
干预措施: K-HEARS Intervention (Behavioral)
Phase 2A -MCI Pilot Trial Immediate Treatment Group
Immediate treatment with K-HEARS intervention
干预措施: K-HEARS Sound Amplifier Intervention (Device)
Phase 2B -KA Older Adult Focused Trial (non-randomized)
Immediate treatment with K-HEARS intervention
干预措施: K-HEARS Intervention (Behavioral)
Phase 2B -KA Older Adult Focused Trial (non-randomized)
Immediate treatment with K-HEARS intervention
干预措施: K-HEARS Sound Amplifier Intervention (Device)
结局指标
主要结局
Hearing Handicap Inventory for the Elderly (HHIE-S) score
时间窗: 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.
次要结局
- Revised UCLA Loneliness Scale(Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group))
- Short Form-12 (SF-12) Mental Component Score(Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group))
- Social Network size Measured by Lubben Social Network Index(Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group))