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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909347
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
NYU Langone Health
Information provided by (Responsible Party):
Johns Hopkins University

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 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.

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.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: PLAN Behavioral: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: PLAN (intervention)
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.
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

Active Comparator: Standard of care (control)
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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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 having had primary care or specialty care provider evaluation for cognitive impairment.


Secondary Outcome Measures :
  1. Caregiver's dementia literacy measured by dementia literacy test [ Time Frame: 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.

  2. Self-efficacy in dementia care measured by dementia self-efficacy scale [ Time Frame: 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.

  3. Social support status as assessed by medical outcomes study scale [ Time Frame: 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. Total scores will range from 8 to 40 with higher scores indicating higher social support.

  4. Depression status as assessed by Patient Health Questionnaire-9 [ Time Frame: 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.

  5. Quality of life (QoL) measured by QoL-dementia caregiver instrument [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Major psychiatric diseases such as schizophrenia
  • Neurological disorders other than Alzheimer's disease that might affect cognition (e.g., stroke)
  • Use of psychotropic drugs including antidepressants, antipsychotics, benzodiazepines or cognitive enhancing agents (e.g., memantine and cholinesterase inhibitors)

Caregiver Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909347


Contacts
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Contact: Hae-Ra Han, PhD, RN 410-614-2669 hhan3@jhu.edu

Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Contact: Simona Kwon, DrPH, MPH    646-501-3479    simona.kwon@nyulangone.org   
Contact: Deborah Min, MPH    646-501-3501    deborah.min@nyulangone.org   
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
NYU Langone Health
Investigators
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Principal Investigator: Hae-Ra Han, PhD, RN Johns Hopkins University

Additional Information:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03909347    
Other Study ID Numbers: IRB00192643
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Korean American elders
Caregivers
dementia Literacy education And Navigation
Community health workers
successful aging
PLAN
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases