PLAN Program for Dementia
(PLAN Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Psychotropic drugs
Disqualifiers: Previous dementia, Axis I diagnoses, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
+3 more
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.
+1 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Korean Community Service Center of Greater WashingtonAnnandale, VA
Korean Community Services of Metropolitan New YorkBayside, NY
Loading ...
Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
NYU Langone HealthCollaborator
National Institute on Aging (NIA)Collaborator
References
[Effective, indicated--and yet without benefit? The goals of dementia drug treatment and the well-being of the patient]. [2018]Individual treatment decisions for patients with Alzheimer dementia are often characterized by uncertainty about the actual benefit that specific treatments or procedures may bring about. It often even remains unclear how the benefit of a treatment may be determined. In this paper, three criteria for determining the benefit of a treatment measure are developed: An intervention (1) must be effective and (2) able to achieve a clinically relevant goal, which is (3) desirable for the individual patient. By using example of anti-dementia drug treatment, it will by shown that even if standard goals of dementia care are achieved, the benefit for the patient may still be questionable. A cognitive improvement or a delay of cognitive decay may even harm the patient. Therefore it is not sufficient to focus on the efficacy of a drug and on general goals of care when making decisions about individual dementia treatments. Rather it is necessary to reflect and discuss explicitly the goals of the individual patient. As shown by various examples, this will facilitate coherent, patient-orientated treatment decisions.
Managed care decisions in Alzheimer's disease. [2007]Alzheimer's disease (AD) and dementia are responsible for high levels of excess per-member costs within managed care organizations (MCOs). To deal with anticipated increases in the prevalence of this disease within their populations, MCOs should take steps to integrate and target proven pharmacologic and non-pharmacologic AD treatments. Key areas of AD care improvement include protocol-driven diagnosis, referral, and treatment; education of primary care physicians and caregivers; development of an integrated case management approach; and use of validated measures to assess outcomes. Published evidence-based guidelines are available to assist MCOs in developing clinical protocols for diagnosis and treatment with effective agents such as cholinesterase inhibitors. Because of the opportunity to prevent costly hospitalizations and other complications as a result of medical and behavioral comorbidities, and because of the need for tightly integrated care, a disease management approach for AD may be justified.
Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). [2021]To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer's disease compared with usual care in memory clinics.
Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. [2022]This pilot study assessed clinical outcomes and quality care for persons with dementia in an acute hospital with PCC, compared with usual care.
Systematic care for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial. [2017]To evaluate the effectiveness of the Systematic Care Program for Dementia (SCPD) on patient institutionalization and to determine the predictors of institutionalization.
The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]Increased length of stay and high rates of adverse clinical events in hospitalised patients with dementia is stimulating interest and debate about which costs may be associated and potentially avoided within this population.
Prevalence of and risk factors for adverse events in Alzheimer's patients receiving anti-dementia drugs in at-home care. [2020]The objective of this study was to clarify the types and prevalence of, and the risk factors for, the adverse events that occur in patients receiving anti-dementia drugs.
Comparative cardiovascular safety of dementia medications: a cross-national study. [2018]To compare the cardiovascular safety of currently marketed dementia medications in new users in the United States and Denmark.
Using clinical registries, administrative data and electronic medical records to improve medication safety and effectiveness in dementia. [2021]Clinical registries, routinely collected administrative data and electronic medical records (EMRs) provide new opportunities to investigate medication safety and effectiveness. This review outlines the strengths and limitations of these data, and highlights recent research related to safe and effective medication use in dementia.
Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. [2023]Potentially inappropriate medications (PIMs) cause adverse events and death. We evaluate the Care Ecosystem (CE) collaborative dementia care program on medication use among community-dwelling persons living with dementia (PLWD).
Reliability and validity of the international dementia alliance schedule for the assessment and staging of care in China. [2019]Clinical and social services both are important for dementia care. The International Dementia Alliance (IDEAL) Schedule for the Assessment and Staging of Care was developed to guide clinical and social care for dementia. Our study aimed to assess the validity and reliability of the IDEAL schedule in China.
["Memory-clinics" in German-speaking countries]. [2015]This article gives an evaluation of the organization, diagnostics and offers of therapy from 41 memory-clinics conducted in German-speaking countries and shows that there is no uniform standard for the care of those suffering from dementia. As a result there are problems with quality assurance and financing. The survey shows that Switzerland has the most extensive as well as intensive care program which is also appropriately funded. It is therefore necessary to provide guidelines for defining a uniform quality standard while taking into account the reasons of the various institutes for implementing such departments. It is also essential that these guidelines do justice to the patients and their relatives.
[What a psychiatrist should do in dementia care]. [2014]On June 18, 2012, a project team for dementia care in the Ministry of Health, Labour and Welfare (MHLW) released a report on future approaches in medical care for dementia. Based on this report, the "5-year plan for promoting dementia measures ("Orange Plan")" was released on September 5. The Orange Plan clearly aims to limit the roles of psychiatry in dementia care to the management of behavioral and psychological symptoms, and to minimize the involvement of psychiatry through implementation of stricter requirements for hospitalization and measures for facilitating discharge. Based on my experience, many of the patients making initial visits to outpatient clinics specializing in dementia are relatively mild cases, and they are typically aware of their condition. Among patients admitted to psychiatric wards, those in acute wards are mostly relatively young men. while those in wards for long-term care comprise mostly elderly women with complications. As opposed to the needs of patients in dementia, the medical needs recognized by policymakers are the needs of the care providers. I have stated that, based on the needs of patients, medical care for dementia should be divided as follows: early diagnosis; early psychiatric and psychological support for patients ; management of behavioral and psychological symptoms; medical care for complications; and terminal care. Furthermore, psychiatrists should be actively involved at each stage. I have also emphasized that providing high-quality psychiatric support for patients with anxiety during the mild phase of cognitive dysfunction greatly influences the subsequent course of illness.
The University of California at Los Angeles Alzheimer's and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. [2021]Dementia is a chronic disease that requires medical and social services to provide high-quality care and prevent complications. As a result of time constraints in practice, lack of systems-based approaches, and poor integration of community-based organizations (CBOs), the quality of care for dementia is poorer than that for other diseases that affect older persons. The University of California at Los Angeles (UCLA) Alzheimer's and Dementia Care (UCLA ADC) program partners with CBOs to provide comprehensive, coordinated, patient-centered care for individuals with Alzheimer's disease and other dementias. The goals of the program are to maximize function, independence, and dignity; minimize caregiver strain and burnout; and reduce unnecessary costs. The UCLA ADC program consists of five core components: recruitment and a dementia registry, structured needs assessments of individuals in the registry and their caregivers, creation and implementation of individualized dementia care plans based on needs assessments and input from the primary care physicians, monitoring and revising care plans as needed, and around-the-clock access for assistance and advice. The program uses a comanagement model with a nurse practitioner Dementia Care Manager working with primary care physicians and CBOs. Based on the first 150 individuals served, the most common recommendations in the initial care plans were referrals to support groups (73%) and Alzheimer's Association Safe Return (73%), caregiver training (45%), and medication adjustment (41%). The program will be evaluated on its ability to achieve the triple aim of better care for individuals, better health for populations, and lower costs.
Developing dementia-capable health care systems: a 12-step program. [2014]Improving the quality, comprehensiveness, and coordination of health care for people with dementia is a primary goal of the National Alzheimer's Plan. In this article, the key principles of high-quality dementia care for nonspecialist clinicians and health care leaders are synthesized, a framework for operationalizing its components is presented, and simple steps for developing dementia-capable health care systems are offered.