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临床试验/NCT03909347
NCT03909347已完成不适用

PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2021年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
574
试验地点
4
主要终点
Number of participants linked to medical service for dementia measured by medical record verification

研究概览

简要总结

Early detection of dementia allows for a transition to early dementia care that may delay or slow deterioration of cognitive functions and functional disabilities and enable families to adequately plan for the potential challenges of dementia caregiving. Currently, little is known about how to effectively evaluate and screen undiagnosed individuals with probable dementia in community-based settings that serve diverse racial/ethnic minorities and how to transition them into the healthcare system for necessary diagnostic follow-up and care for dementia. Using Korean Americans as an example, we propose to test trained community health workers as an effective and sustainable approach for early detection of dementia and care in racial/ethnic minority communities with limited resources.

详细描述

Studies have shown that ethnic-racial minority elders are more likely to be neglected from appropriate dementia care in time than the white counterparts. Among minorities group, Korean Americans (KAs) are the 4th largest and one of the most rapidly growing Asian subpopulations and have been characterized as under-resourced and underserved population of dementia care. This research is being done to understand how an education and navigation support program led by trained community health workers (CHWs) helps Korean American elders with probable dementia and the Korean American elders' caregivers. In a 2-arm randomized controlled trial (RCT) with 288 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained CHWs for undiagnosed KA elders with probable dementia and the KA elders' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to usual care, and (3) examine whether the effect of PLAN differs across age, sex, English proficiency and education caregiver subgroups. Exploratory Aim 1 is to explore the effect of PLAN on Korean elders with probable dementia and caregiver development of a plan regarding dementia care at 6 months in comparison to usual care. The other two Exploratory Aims are to test the applicability of this study in another environment: Exploratory Aim 2: Using an equity-informed human-centered design framework, scale PLAN for implementation in ethnic daycare and Exploratory Aim 3: Pilot test the feasibility and acceptability of PLAN in ethnic adult daycare.

Aim 1 tests the following hypothesis: (1) Korean elders with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group. Aim 2 tests the following hypothesis: Caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Inclusion Criteria:
  • Self-identified as first-generation KA
  • Age 65 years or older
  • Has a caregiver who lives in the same household or has at least weekly interactions
  • Able to consent or has a proxy available for consent
  • Written consent to participate in the study
  • Caregiver Inclusion Criteria:
  • Age 18 years or older
  • Able to read and speak Korean
  • Lives in the same household with the elder or has at least weekly interactions
  • Written consent to participate in the study and to allow the team to audit medical records for linkage to medical service for dementia

排除标准

  • Previous diagnosis of dementia
  • All Axis I diagnoses other than depressive disorders (e.g., schizophrenia, bipolar disorder, or substance use disorder)
  • Neurological disorders other than Alzheimer's disease that might affect cognition (e.g., stroke)
  • Use of psychotropic drugs including antipsychotics,
  • Caregiver Exclusion Criteria:
  • Plan to move from the area within 6 months
  • Active treatment for a terminal illness or in hospice

研究组 & 干预措施

PLAN (intervention)

Experimental

Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.

干预措施: PLAN (Behavioral)

Standard of care (control)

Active Comparator

Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.

干预措施: Standard of Care (Behavioral)

结局指标

主要结局

Number of participants linked to medical service for dementia measured by medical record verification

时间窗: 6 months

Linkage to medical service for dementia is defined as the completion of a medical clinic visit by a Korean older adult with probable dementia.

Number of Participants Linked to Medical Service for Dementia Measured by Medical Record Verification

时间窗: 6 months

Linkage to medical service for dementia is defined as the completion of a medical clinic visit by a Korean older adult with probable dementia.

次要结局

  • Caregiver's dementia literacy measured by dementia literacy test(6 months)
  • Self-efficacy in dementia care measured by dementia self-efficacy scale(6 months)
  • Social support status as assessed by medical outcomes study scale(6 months)
  • Depression status as assessed by Patient Health Questionnaire-9(6 months)
  • Quality of life (QoL) measured by QoL-dementia caregiver instrument(6 months)
  • Caregiver's Dementia Literacy Measured by Dementia Literacy Test(Baseline, 3 months, and 6 months)
  • Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale(Baseline, 3 months, and 6 months)
  • Social Support Status as Assessed by Medical Outcomes Study Scale(Baseline, 3 months, and 6 months)
  • Depression Status as Assessed by Patient Health Questionnaire-9(Baseline, 3 months, and 6 months)
  • Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument(Baseline, 3 months, 6 months)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (4)

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