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

Dementia Clinical Trial

— PLAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909347
• Other study ID #: IRB00242241
• Secondary ID: R01AG062649-01
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Hae-Ra Han, PhD, RN
• Phone: 410-614-2669
• Email: hhan3[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• 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
• 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.

Locations

Country	Name	City	State
United States	Korean Community Service Center of Greater Washington	Annandale	Virginia
United States	Korean Community Services of Metropolitan New York	Bayside	New York

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA), National Institutes of Health (NIH), NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants linked to medical service for dementia measured by medical record verification	Linkage to medical service for dementia is defined as having had primary care or specialty care provider evaluation for cognitive impairment.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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. Total scores will range from 8 to 40 with higher scores indicating higher social support.	6 months
Secondary	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.	6 months
Secondary	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.	6 months

External Links

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