DementiaPLANNCT03909347
PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
A study testing PLAN in people with Dementia, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- PLAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2021to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 Exclusion Criteria:
- Plan to move from the area within 6 months
- Active treatment for a terminal illness or in hospice
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Korean Community Service Center of Greater Washington
Annandale, Virginia, 22003
Korean Community Services of Metropolitan New York
Bayside, New York, 11361
About this study
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.
Read the detailed description
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.
- Conditions
- Dementia
- Being tested
- PLAN, Standard of Care
- Keywords
- Korean American elders, Caregivers, dementia Literacy education And Navigation, Community health workers, successful aging, PLAN
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLANBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Caregiver's Dementia Literacy Measured by Dementia Literacy Test
Dementia 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.
Measured: Baseline, 3 months, and 6 months
Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale
Dementia 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.
Measured: Baseline, 3 months, and 6 months
Social Support Status as Assessed by Medical Outcomes Study Scale
The 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. Mean scores will range from 1 to 5, with higher scores indicating greater social support.
Measured: Baseline, 3 months, and 6 months
Depression Status as Assessed by Patient Health Questionnaire-9
Patient 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.
Measured: Baseline, 3 months, and 6 months
Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument
QoL-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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start20 Apr 2021
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), NYU Langone Health, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Hae-Ra Han, PhD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909347
- Sponsor's protocol ID
- IRB00242241
- Other IDs
- R01AG062649-01
- Acronym
- PLAN
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2019
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39998873Han 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.
PubMed 39622468Han 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.
PubMed 39443891Baumeister 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.
PubMed 37963101Han 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.
PubMed 36908462
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
- ClinicalTrials.gov ID
- NCT03909347
- Acronym / sponsor ID
- PLAN / IRB00242241
- Conditions
- Dementia
- Keywords
- Korean American elders, Caregivers, dementia Literacy education And Navigation, Community health workers, successful aging, PLAN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), NYU Langone Health, National Institute on Aging (NIA)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PLAN (intervention) | Experimental | Behavioral: PLANGroup 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. |
| Standard of care (control) | Active comparator | Behavioral: Standard of CareGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLANThe 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 | Behavioural | PLAN (intervention) |
| Standard of CareThe 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. | Behavioural | Standard of care (control) |
Primary outcome
Number of Participants Linked to Medical Service for Dementia Measured by Medical Record Verification
Time frame: 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.
5 secondary outcomes
Caregiver's Dementia Literacy Measured by Dementia Literacy Test
Time frame: Baseline, 3 months, and 6 months
Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale
Time frame: Baseline, 3 months, and 6 months
Social Support Status as Assessed by Medical Outcomes Study Scale
Time frame: Baseline, 3 months, and 6 months
Depression Status as Assessed by Patient Health Questionnaire-9
Time frame: Baseline, 3 months, and 6 months
Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument
Time frame: Baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39998873Min 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.
- Derived from this study: PubMed 39622468Han 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.
- Derived from this study: PubMed 39443891Han 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.
- Derived from this study: PubMed 37963101Baumeister 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.
- Derived from this study: PubMed 36908462Han 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.
- Alzheimer's Association brochure about signs of dementia and dementia treatment, which is publicly available in Korean.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hae-Ra Han, PhD, RN principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAN in people with Dementia, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Linked to Medical Service for Dementia Measured by Medical Record Verification (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909347, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.