Dementia
Conditions
Keywords
Korean American elders, Caregivers, dementia Literacy education And Navigation, Community health workers, successful aging, PLAN
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.
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.
Interventions
BEHAVIORALPLAN
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
BEHAVIORALStandard 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.
Sponsors
Johns Hopkins University
National Institutes of Health (NIH)
NYU Langone Health
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Linked to Medical Service for Dementia Measured by Medical Record Verification | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver's Dementia Literacy Measured by Dementia Literacy Test | Baseline, 3 months, and 6 months | 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. |
| Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale | Baseline, 3 months, and 6 months | 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. |
| Social Support Status as Assessed by Medical Outcomes Study Scale | Baseline, 3 months, and 6 months | 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. |
| Depression Status as Assessed by Patient Health Questionnaire-9 | Baseline, 3 months, and 6 months | 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. |
| Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument | Baseline, 3 months, 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHae-Ra Han, PhD, RN
Johns Hopkins University
Participant flow
Recruitment details
The study utilized remote, virtual, and in-person recruitment strategies. Recruitment efforts included social media, ethnic media, and community-based outreach at adult daycare centers, churches, and senior centers. Recruitment began February 2021. The first dyad was enrolled on April 20, 2021. Recruitment continued through January 2024.
Pre-assignment details
Per protocol, participants are considered enrolled upon randomization. * 786 (393 older adults and 393 caregivers) consented. * 210 (105 dyads) were excluded prior to assignment * 184 were ineligible * 22 declined for caregiver-related reasons, * 2 declined by older adult choice, * 2 were excluded: 1 older adult died; caregiver excluded after partner's death
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Caregivers | 66.9 years STANDARD_DEVIATION 13.2 |
| Age, Continuous Care Recipients (Korean Older Adults) | 82.5 years STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 146 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Care Recipients (Korean Older Adults) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Care Recipients (Korean Older Adults) Not Hispanic or Latino | 141 Participants |
| Ethnicity (NIH/OMB) Care Recipients (Korean Older Adults) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 287 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers White | 0 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) Asian | 287 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) Black or African American | 0 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) More than one race | 0 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Care Recipients (Korean Older Adults) White | 0 Participants |
| Region of Enrollment United States | 574 Participants |
| Sex: Female, Male Caregivers Female | 106 Participants |
| Sex: Female, Male Caregivers Male | 47 Participants |
| Sex: Female, Male Care Recipients (Korean Older Adults) Female | 109 Participants |
| Sex: Female, Male Care Recipients (Korean Older Adults) Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 146 | 1 / 146 | 1 / 141 | 3 / 141 |
| other Total, other adverse events | 8 / 146 | 0 / 146 | 3 / 141 | 0 / 141 |
| serious Total, serious adverse events | 0 / 146 | 0 / 146 | 0 / 141 | 0 / 141 |
Outcome results
None listed