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

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PLAN
Standard of Care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dementia focused on measuring Korean American elders, Caregivers, dementia Literacy education And Navigation, Community health workers, successful aging, PLAN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korean Community Services of Metropolitan New YorkRecruiting
  • Korean Community Service Center of Greater WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PLAN (intervention)

Standard of care (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 8, 2019
Last Updated
July 11, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), NYU Langone Health, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03909347
Brief Title
PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Acronym
PLAN
Official Title
PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), NYU Langone Health, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Korean American elders, Caregivers, dementia Literacy education And Navigation, Community health workers, successful aging, PLAN

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLAN (intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care (control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PLAN
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants linked to medical service for dementia measured by medical record verification
Description
Linkage to medical service for dementia is defined as having had primary care or specialty care provider evaluation for cognitive impairment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Caregiver's dementia literacy measured by dementia literacy test
Description
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.
Time Frame
6 months
Title
Self-efficacy in dementia care measured by dementia self-efficacy scale
Description
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.
Time Frame
6 months
Title
Social support status as assessed by medical outcomes study scale
Description
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.
Time Frame
6 months
Title
Depression status as assessed by Patient Health Questionnaire-9
Description
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.
Time Frame
6 months
Title
Quality of life (QoL) measured by QoL-dementia caregiver instrument
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae-Ra Han, PhD, RN
Phone
410-614-2669
Email
hhan3@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae-Ra Han, PhD, RN
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korean Community Services of Metropolitan New York
City
Bayside
State/Province
New York
ZIP/Postal Code
11361
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Yeon Ahn
Phone
347-348-3233
Email
nym.plan@gmail.com
First Name & Middle Initial & Last Name & Degree
Sara Kim
Phone
347-348-3233
Email
skim@kcsny.org
Facility Name
Korean Community Service Center of Greater Washington
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seunghee Yeo
Phone
703-354-6345
Email
cmd.plan@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji-Young Cho, PhD
Phone
703-354-6345
Email
jycho@kcscgw.org

12. IPD Sharing Statement

Links:
URL
http://www.alz.org/asian/overview.asp?nL=KO&dL=KO
Description
Alzheimer's Association brochure about signs of dementia and dementia treatment, which is publicly available in Korean.

Learn more about this trial

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

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