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PLAN Program for Dementia (PLAN Trial)

N/A

Waitlist Available

Led By Hae-Ra Han, PhD, RN

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 65 years or older

Be older than 18 years old

Must not have

Use of psychotropic drugs including antipsychotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to study whether an education and navigation support program helps Korean American elders with probable dementia and their caregivers.

Who is the study for?

This trial is for first-generation Korean American elders aged 65+, with probable dementia but no formal diagnosis, and who have a caregiver interacting weekly. They must be able to consent or have someone who can on their behalf. Those already diagnosed with dementia, other major mental health conditions, neurological issues affecting cognition, or on antipsychotics cannot join.

What is being tested?

The study tests an education and support program (PLAN) by community health workers against standard care for improving dementia care linkage and caregivers' abilities in managing the condition. It's a randomized controlled trial involving dyads of elders and caregivers to see if PLAN improves outcomes like literacy, self-efficacy, social support, quality of life, and depression levels.

What are the potential side effects?

Since this intervention involves educational support rather than medication there are no direct medical side effects; however participants may experience emotional distress or fatigue from engaging in the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for mental health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants linked to medical service for dementia measured by medical record verification

Secondary study objectives

Caregiver's dementia literacy measured by dementia literacy test

Depression status as assessed by Patient Health Questionnaire-9

Dementia

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PLAN (intervention)Experimental Treatment1 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.

Group II: Standard of care (control)Active Control1 Intervention

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.

0 / 2Eligibility criteria met