PLAN Program for Dementia

(PLAN Trial)

Recruiting at 1 trial location

Overseen By Hae-Ra Han, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Psychotropic drugs

Disqualifiers: Previous dementia, Axis I diagnoses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a community-based program led by trained community health workers can assist Korean American elders with probable dementia and their caregivers. Participants will either receive an educational session and ongoing support through the PLAN program or standard care with a pamphlet and physician referral. The trial seeks to improve understanding of dementia, increase medical service use, and enhance support for caregivers. Korean American elders aged 65 and older, who have not been diagnosed with dementia but have a caregiver they interact with regularly, may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could shape future community health programs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients using psychotropic drugs (medications affecting mood, perception, or behavior) like antipsychotics. It's best to discuss your specific medications with the trial team.

What prior data suggests that this education and navigation support program is safe for Korean American elders with probable dementia and their caregivers?

Research has shown that community programs like PLAN are safe and well-received. The PLAN program offers education and support through trained community health workers to assist Korean American elders with dementia and their caregivers. This approach mirrors other dementia care models that aim to enhance quality of life without medication.

No specific clinical trials have reported negative effects related to the PLAN program. However, programs emphasizing education and support, rather than medication, typically encounter fewer safety issues. As an educational and support service, the PLAN program is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PLAN Program for Dementia because it offers a personalized and community-oriented approach to supporting dementia care. Unlike typical treatments that mainly involve medication and clinical visits, this program includes a one-time, one-hour educational session conducted at home or a convenient community location. Additionally, it provides ongoing monthly support through calls from a community health worker to help participants with care barriers and logistics like scheduling appointments and arranging transportation. This approach aims to empower patients and caregivers by providing practical, ongoing support that addresses real-life challenges in managing dementia care.

What evidence suggests that the PLAN program is effective for dementia care in Korean American elders?

Research has shown that community programs like the PLAN program, which participants in this trial may receive, can greatly assist people with dementia and their caregivers. Studies have found that trained community health workers leading these programs reduce behavior problems in people with dementia compared to regular care. Caregivers also benefit by gaining more knowledge about dementia and feeling more confident in their caregiving. They report a better quality of life and experience less depression. Overall, education and support from community health workers have proven effective in improving care for people with dementia and their families. ^{1 2 6 7 8}

Who Is on the Research Team?

Hae-Ra Han, PhD, RN

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

This criterion means the participant must have a certain level of disease severity (CDR 1.0+).

Has a caregiver who lives in the same household or has at least weekly interactions

You identify as a first-generation Korean American.

Exclusion Criteria

I have no cognitive impairments other than Alzheimer's disease.

I am currently taking medication for mental health issues.

You have a diagnosis of a depressive disorder, but not of schizophrenia, bipolar disorder, or substance use disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a one-time, one-hour education session at home or a convenient community location, followed by monthly calls from a community health worker to identify barriers to dementia care and assist with appointments or transportation.

6 months

1 in-person visit, monthly phone calls

Follow-up

Participants are monitored for outcomes such as dementia literacy, self-efficacy, social support, depression, and quality of life.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PLAN
• Standard of Care

Trial Overview 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.

How Is the Trial Designed?

Group I: PLAN (intervention) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The IDEAL schedule, assessed in a study of 282 dementia patients and their caregivers in China, demonstrated high inter-rater reliability with a score of 0.93, indicating consistent results between different raters.

The IDEAL schedule showed strong correlations with established dementia assessment tools, such as the Clinical Dementia Rating and Mini-Mental Status Examination, confirming its validity as a reliable tool for staging dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity of the international dementia alliance schedule for the assessment and staging of care in China. Wang, X., Sun, Z., Xiong, L., et al.[2019]

The UCLA Alzheimer's and Dementia Care program effectively partners with community-based organizations to provide comprehensive, patient-centered care for individuals with dementia, aiming to improve their quality of life and reduce caregiver strain.

Initial results from the first 150 participants indicate that the program's care plans commonly include referrals to support groups and caregiver training, highlighting its focus on holistic support for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The University of California at Los Angeles Alzheimer's and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. Reuben, DB., Evertson, LC., Wenger, NS., et al.[2021]

The article outlines essential principles for enhancing dementia care, aiming to improve the quality and coordination of health services for individuals with dementia, as emphasized by the National Alzheimer's Plan.

It provides a framework and practical steps for nonspecialist clinicians and healthcare leaders to create dementia-capable healthcare systems, ensuring better support for patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing dementia-capable health care systems: a 12-step program. Borson, S., Chodosh, J.[2014]

The 'Orange Plan' released by Japan's Ministry of Health aims to limit psychiatric involvement in dementia care primarily to managing behavioral and psychological symptoms, which may not fully address the needs of patients.

The author argues for a more comprehensive approach to dementia care that includes early diagnosis and psychiatric support throughout all stages of the illness, emphasizing that quality psychiatric care during the early phases can significantly impact the progression of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What a psychiatrist should do in dementia care]. Saito, M.[2014]

Hospital-acquired complications like urinary tract infections, pressure areas, pneumonia, and delirium account for 6.4% of total hospital costs for patients over 50, with dementia patients experiencing these complications at a significantly higher rate (RR 2.5).

These complications lead to an eightfold increase in hospital length of stay and double the average episode cost, highlighting the need for improved care models to prevent such issues, especially in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. Bail, K., Goss, J., Draper, B., et al.[2022]

In a pilot study involving 47 participants aged 60 and over with dementia, person-centered care (PCC) significantly improved behavioral and neuropsychiatric symptoms and care quality compared to usual care after 4-5 days.

Sustained improvements in care quality were observed for patients with longer hospital stays, indicating that PCC can be beneficial for enhancing the overall care experience for individuals with dementia in acute hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. Chenoweth, L., Williams, A., Fry, M., et al.[2022]

In a study of 46,737 Medicare beneficiaries and 29,496 Danish participants, cholinesterase inhibitors like donepezil showed similar cardiovascular safety profiles, with no significant differences in the risk of myocardial infarction (MI) or heart failure compared to other medications.

Memantine was linked to a higher risk of fatal or nonfatal MI and cardiac death in the Danish cohort, as well as increased all-cause mortality in both cohorts, suggesting that patients prescribed memantine may have been sicker overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. Fosbøl, EL., Peterson, ED., Holm, E., et al.[2018]

Clinical registries and electronic medical records (EMRs) allow researchers to study medication safety and effectiveness in larger, more diverse populations, including those often excluded from randomized controlled trials, which can reveal rare adverse events over longer follow-up periods.

Despite some variability in the accuracy of diagnoses in administrative data, these sources provide valuable insights into medication exposure and prescribing patterns, helping to identify risk factors and improve treatment strategies for dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using clinical registries, administrative data and electronic medical records to improve medication safety and effectiveness in dementia. Ilomäki, J., Lai, EC., Bell, JS.[2021]

The paper outlines three key criteria for determining the benefit of treatments for Alzheimer dementia: effectiveness, achievement of clinically relevant goals, and desirability for the individual patient.

It emphasizes that even if standard treatment goals are met, the actual benefit to the patient may be questionable, highlighting the need for personalized discussions about treatment goals rather than solely focusing on drug efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effective, indicated--and yet without benefit? The goals of dementia drug treatment and the well-being of the patient]. Synofzik, M.[2018]

A comprehensive care plan implemented in 50 memory clinics for patients with mild to moderate Alzheimer's disease did not significantly reduce the rate of functional decline compared to usual care, as shown in a study involving 1131 patients over two years.

Both groups experienced similar rates of decline in daily living activities, indicating that the specific care plan did not provide additional benefits in managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). Nourhashemi, F., Andrieu, S., Gillette-Guyonnet, S., et al.[2021]

The Systematic Care Program for Dementia (SCPD) did not significantly reduce the rate of institutionalization for dementia patients after 12 months, despite being implemented across six community mental health services with 295 patient-caregiver dyads.

Key predictors of institutionalization included the caregiver's sense of competence and depressive symptoms, as well as the patient's behavioral issues and severity of dementia, highlighting the importance of caregiver support in managing dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic care for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial. Spijker, A., Wollersheim, H., Teerenstra, S., et al.[2017]

A survey of 41 memory clinics in German-speaking countries revealed a lack of uniform standards in dementia care, leading to issues with quality assurance and funding.

Switzerland was identified as having the most comprehensive and well-funded dementia care program, highlighting the need for standardized guidelines to improve care quality across different regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

["Memory-clinics" in German-speaking countries]. Aguirreche, E., Zeppenfeld, G., Kolb, GF.[2015]

Managed care organizations (MCOs) should implement integrated care strategies for Alzheimer's disease (AD) to manage rising costs and improve patient outcomes, focusing on both pharmacologic and non-pharmacologic treatments.

Evidence-based guidelines suggest that MCOs can enhance AD care through standardized protocols for diagnosis and treatment, education for healthcare providers, and integrated case management, which may help prevent costly hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managed care decisions in Alzheimer's disease. Fillit, HM.[2007]

In a survey of 3712 patients, 863 were prescribed anti-dementia drugs, with 21% experiencing confirmed adverse events, primarily excitation/anxiety (45.1%).

Risk factors for these adverse events included polypharmacy (taking 10 or more medications), inappropriate use of anti-dementia drugs, and irregular medication adherence, highlighting the need for careful medication management by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of and risk factors for adverse events in Alzheimer's patients receiving anti-dementia drugs in at-home care. Imai, H., Hirai, T., Kumazawa, R., et al.[2020]

The Care Ecosystem (CE) program significantly reduced the use of potentially inappropriate medications (PIMs) among 490 community-dwelling individuals living with dementia over a 12-month period, with a notable decrease of 0.35 PIMs per participant compared to usual care.

The CE intervention not only lowered the overall number of PIMs, including anticholinergics, benzodiazepines, and opioids, but also led to more frequent adjustments in anti-dementia medication regimens, indicating an optimization of medication use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Liu, AK., Possin, KL., Cook, KM., et al.[2023]

Citations

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Clinical Outcomes and Cost-Effectiveness of Collaborative ... Clinical Outcomes. Compared with people living with dementia receiving usual care, those receiving CDCM for 6 months had fewer behavioral and ...

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Programmatic research outcomes used to establish the ... Twelve programmatic outcomes were identified focusing on Caregiver Well-Being and Caregiver Support. Caregiver Well-Being outcomes were ...

3. aspe.hhs.gov aspe.hhs.gov/national-plan-address-alzheimers-disease

National Plan to Address Alzheimer's Disease Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025. Goal 2: Enhance Care Quality and Efficiency. Goal 3: Expand Supports for People with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.

5. nia.nih.gov nia.nih.gov/about/2025-nih-dementia-research-progress-report

2025 NIH Alzheimer's Disease and Related Dementias ... The research findings suggest that cognitively enriched tai chi was superior to the standard form in improving global cognition and this outcome ...

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Data, Assessment, and Analysis For public health professionals, learn how to access and use Behavioral Risk Factor Surveillance System (BRFSS) data on Alzheimer's and dementia.

7. cms.gov cms.gov/priorities/innovation/innovation-models/guide

Guiding an Improved Dementia Experience (GUIDE) Model The GUIDE Model focuses on comprehensive, coordinated dementia care and aims to improve quality of life for people with dementia, reduce strain on their unpaid ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70235

2025 Alzheimer's disease facts and figures Between 2000 and 2022, deaths from stroke, heart disease, and HIV decreased, whereas reported deaths from AD increased by more than 142%. Nearly ...