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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03909347
Acronym
PLAN
Enrollment
288
Registered
2019-04-10
Start date
2021-04-20
Completion date
2026-08-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Korean American elders, Caregivers, dementia Literacy education And Navigation, Community health workers, successful aging, PLAN

Brief summary

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 test 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 and Exploratory Aim test the following hypotheses: (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 1) and (2) Korean elders with probable dementia and the KA elders' caregivers who receive the PLAN will have higher rates of having a plan for dementia care than those in the control group (Exploratory Aim). 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.

Interventions

BEHAVIORALPLAN

The study intervention, PLAN is a multifaceted intervention led by trained CHW. It consists of two main components: dementia literacy education and phone counseling with navigation assistance through (1) 1-hour visit for dementia literacy education and (2)monthly counseling with navigation assistance

BEHAVIORALStandard of Care

The investigators will refer control group participants to participants' primary physicians for follow-up and provide an Alzheimer's Association brochure about signs of dementia and dementia treatment, which is publicly available in Korean.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
NYU Langone Health
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Our study will use PRECEDE-PROCEED model for planning and evaluation of interventions to address our intervention delivery model using trained community health workers (CHWs) and community-participatory approaches. Predisposing factors of sociodemographic characteristics like caregiver age, gender, level of education, and English proficiency and the KA elder's Clinical Dementia Rating (CDR) score will be considered as covariates. Enabling factors for the study include caregiver's dementia literacy and self-efficacy in dementia care, and the KA elder's access to medical care, and reinforcing factors include social support and primary physician recommendation for cognitive testing.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Patient Inclusion Criteria: * Self-identified as first-generation KA * Age 65 years or older * CDR 1.0+ * 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 Patient

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants linked to medical service for dementia measured by medical record verification6 monthsLinkage to medical service for dementia is defined as the completion of a medical clinic visit by a Korean older adult with probable dementia.

Secondary

MeasureTime frameDescription
Caregiver's dementia literacy measured by dementia literacy test6 monthsDementia literacy test is a 11-item instrument (true or false). Scoring of the dementia literacy instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores can range from 0 to 11 with higher scores indicating higher health literacy.
Self-efficacy in dementia care measured by dementia self-efficacy scale6 monthsDementia self-efficacy scale is a 10-item instrument. Scoring of the dementia self-efficacy scale ranges from not at all certain coded as 1 to very certain coded as 10 for each item. Total scores will range from 10 to 100 with higher scores indicating higher self-efficacy.
Social support status as assessed by medical outcomes study scale6 monthsThe 8-item scale of medical outcomes study scoring ranges from none of the time coded as 1 to all of the time coded as 5 for each item. Total scores will range from 8 to 40 with higher scores indicating higher social support.
Depression status as assessed by Patient Health Questionnaire-96 monthsPatient health questionnaire-9 is a 9-item instrument and scoring ranges from not at all coded as 0 to nearly every day coded as 3. Total scores will range from 0 to 27 with higher score indicating higher depression.
Quality of life (QoL) measured by QoL-dementia caregiver instrument6 monthsQoL-dementia caregiver is a 13-item instrument and scoring ranges from poor coded as 1 to excellent coded as 4 for each item. Total scores will range from 13 to 52 with higher scores indicating higher quality of life.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026