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PLAN Program for Dementia

Annandale, Virginia
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.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

288 Participants Needed

Why Other Patients Applied

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

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Obesity PatientAge: 58

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

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Pancreatic Cancer PatientAge: 40

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

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Depression PatientAge: 51

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

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Healthy Volunteer PatientAge: 38

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Frequently Asked Questions

How much do clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials ?
Most recently, we added PLAN Program for Dementia to the Power online platform.

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