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

NCT ID: NCT03909347

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PLAN (intervention)

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.

Group Type EXPERIMENTAL

PLAN

Intervention Type BEHAVIORAL

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

Standard of care (control)

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.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PLAN

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

Intervention Type BEHAVIORAL

Standard 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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

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,


* Plan to move from the area within 6 months
* Active treatment for a terminal illness or in hospice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role lead

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hae-Ra Han, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Korean Community Services of Metropolitan New York

Bayside, New York, United States

Site Status

Korean Community Service Center of Greater Washington

Annandale, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Min D, Yun JY, Parslow C, Jajodia A, Han HR. Online-Based Recruitment Methods for Community-Dwelling Older Adults: Scoping Review and Lessons Learned From the PLAN Trial. J Med Internet Res. 2025 Feb 25;27:e55082. doi: 10.2196/55082.

Reference Type DERIVED
PMID: 39998873 (View on PubMed)

Han HR, Perrin N, Kwon SC, Joo J, Yun JY, Min D, Lee HB. PLAN-Dementia literacy education and navigation for Korean elders with probable dementia and their caregivers: Rationale, methods, and design of a community-based, randomized, controlled, multi-site clinical trial. Contemp Clin Trials. 2025 Jan;148:107771. doi: 10.1016/j.cct.2024.107771. Epub 2024 Nov 30.

Reference Type DERIVED
PMID: 39622468 (View on PubMed)

Han HR, Yun JY, Min D, Razaz M. Health literacy demand and attitudes toward COVID-19 prevention measures among Korean American older adults and their caregivers. BMC Public Health. 2024 Oct 23;24(1):2941. doi: 10.1186/s12889-024-20427-7.

Reference Type DERIVED
PMID: 39443891 (View on PubMed)

Baumeister A, Aldin A, Chakraverty D, Hubner C, Adams A, Monsef I, Skoetz N, Kalbe E, Woopen C. Interventions for improving health literacy in migrants. Cochrane Database Syst Rev. 2023 Nov 14;11(11):CD013303. doi: 10.1002/14651858.CD013303.pub2.

Reference Type DERIVED
PMID: 37963101 (View on PubMed)

Han HR, Min D, Yun JY, Joo JH, Lee HB, Kwon S. The impact of anti-Asian racism on routine activities and mental health among Korean American older adults and their caregivers. Front Public Health. 2023 Feb 22;11:958657. doi: 10.3389/fpubh.2023.958657. eCollection 2023.

Reference Type DERIVED
PMID: 36908462 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.alz.org/asian/overview.asp?nL=KO&dL=KO

Alzheimer's Association brochure about signs of dementia and dementia treatment, which is publicly available in Korean.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AG062649-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00242241

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cohort Study on Cognitive Decline in Elderly
NCT07093892 NOT_YET_RECRUITING
Rural Dementia Caregiver Project
NCT04428112 COMPLETED NA