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

NCT03909347 | Completed Results

• 2 other identifiers: IRB00242241R01AG062649-01
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dementia

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Behavioral: PLAN

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.

Behavioral: Standard of Care

Interventions

PLAN 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

PLAN (intervention)

Standard of Care 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.

Standard of care (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: lead
• NYU Langone Health: collaborator

Study Sites (2)

Korean Community Services of Metropolitan New York

Bayside, New York, 11361, United States

Location

Korean Community Service Center of Greater Washington

Annandale, Virginia, 22003, United States

Location

Related Publications (5)

• 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.

  PMID: 39998873 DERIVED

• 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.

  PMID: 39622468 DERIVED

• 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.

  PMID: 39443891 DERIVED

• 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.

  PMID: 37963101 DERIVED

• 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.

  PMID: 36908462 DERIVED

Related Links

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

MeSH Terms

Conditions

Dementia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Haera Han
• Organization: Johns Hopkins University

hhan3@jh.edu

4106142669

Study Officials

• Hae-Ra Han, PhD, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: April 20, 2021
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: August 3, 2026
• Results First Posted: August 3, 2026

Record last verified: 2026-07

Locations

US (2)