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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the PLAN treatment for dementia?

The PLASA study showed that a specific care plan can help slow down the decline in daily functioning for people with Alzheimer's disease compared to usual care. Additionally, person-centered care in hospitals has been linked to better clinical outcomes for dementia patients. ^{1 2 3 4 5}

Is the PLAN Program for Dementia safe for humans?

Research on dementia treatments shows that medication safety is a key focus, with studies comparing the safety of different dementia drugs and examining adverse events in patients. While specific safety data for the PLAN Program isn't mentioned, general research on dementia care highlights the importance of monitoring for adverse events and ensuring safe medication use. ^{6 7 8 9 10}

How is the PLAN treatment for dementia different from other treatments?

The PLAN treatment for dementia is unique because it focuses on comprehensive, coordinated, patient-centered care by integrating medical and social services, aiming to maximize function and independence while minimizing caregiver strain and costs. This approach involves creating individualized care plans and working closely with community-based organizations, which is different from standard treatments that may not offer such a holistic and integrated approach. ^{11 12 13 14 15}

Research Team

Hae-Ra Han, PhD, RN

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Systematic care for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial. [2017]

6. England pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]

7. United States 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Using clinical registries, administrative data and electronic medical records to improve medication safety and effectiveness in dementia. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Reliability and validity of the international dementia alliance schedule for the assessment and staging of care in China. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

["Memory-clinics" in German-speaking countries]. [2015]

13. Japan pubmed.ncbi.nlm.nih.gov

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

14. United States 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. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Developing dementia-capable health care systems: a 12-step program. [2014]