Clinical trial NCT03909347: PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Official title: PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Korean American elders
Caregivers
dementia Literacy education And Navigation
Community health workers
successful aging
PLAN
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: NYU Langone Health
name: National Institute on Aging (NIA)
First posted: 2019-04-10
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.


Eligibility 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 Exclusion Criteria:

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

Primary outcomes:
measure: Number of participants linked to medical service for dementia measured by medical record verification
timeFrame: 6 months
Secondary outcomes:
measure: Caregiver's dementia literacy measured by dementia literacy test
timeFrame: 6 months
measure: Self-efficacy in dementia care measured by dementia self-efficacy scale
timeFrame: 6 months
measure: Social support status as assessed by medical outcomes study scale
timeFrame: 6 months
measure: Depression status as assessed by Patient Health Questionnaire-9
timeFrame: 6 months
measure: Quality of life (QoL) measured by QoL-dementia caregiver instrument
timeFrame: 6 months
Other outcomes:
Locations:
city: Bayside
country: United States
facility: Korean Community Services of Metropolitan New York
state: New York
city: Annandale
country: United States
facility: Korean Community Service Center of Greater Washington
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Hae-Ra Han, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: