Telehealth for Lewy Body Dementia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Disqualifiers: Severe dementia, No internet, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
Lewy body dementia (LBD) is the 2nd most common neurodegenerative dementia in the US. Optimal care requires an interdisciplinary approach, however often faced barriers include rural residence, limited access to specialists, travel distance, limited awareness of resources, and physical, cognitive, and behavioral impairments making travel to appointments challenging. Delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with LBD.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Telehealth for Lewy Body Dementia is an effective treatment?
The available research does not provide specific data on the effectiveness of Telehealth for Lewy Body Dementia. Instead, it highlights the challenges faced by caregivers, such as high stress and isolation, and their preference for web-based resources. This suggests that Telehealth could potentially address these unmet needs by offering support and information online, but direct evidence of its effectiveness is not provided in the research.12345
What safety data exists for telehealth treatment in Lewy Body Dementia?
The provided research does not contain specific safety data for telehealth treatments like Tele-neurohub or Virtual Neurology Care in Lewy Body Dementia. The studies focus on pharmacological treatments and hospitalization outcomes in Lewy Body Dementia, but do not address telehealth interventions.36789
Is Tele-neurohub a promising treatment for Lewy Body Dementia?
Eligibility Criteria
This trial is for people with Lewy Body Dementia (LBD), which includes some Parkinson's disease symptoms. Participants need a specialist-confirmed LBD diagnosis, mild to moderate dementia, and internet access with Zoom. They must speak English and have a caregiver at home willing to join the study. Healthcare professionals involved should have over a year of experience with LBD.Inclusion Criteria
Healthcare Professional: Willingness to participate in the study
Healthcare Professional: > 1 year of experience with LBD
Participant with Lewy Body Dementia (LBD): Fluency in English
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the tele-neurohub intervention, including telemedicine appointments with various specialists and bi-weekly PT and OT sessions
6 months
Telemedicine appointments at baseline, 3 months, and 6 months; PT and OT every 2 weeks
Follow-up
Participants are monitored for feasibility, acceptability, and appropriateness of the tele-neurohub model
4 weeks
Treatment Details
Interventions
- Tele-neurohub (Behavioral Intervention)
Trial OverviewThe trial is testing 'Tele-neurohub', a video technology system designed to deliver interdisciplinary care remotely to patients with LBD, aiming to improve their access to specialist care without needing to travel.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Tele-neurohubExperimental Treatment1 Intervention
This group will receive the tele-neurohub intervention which includes telemedicine appointments with the neurologist, speech therapist, social worker, and nutritionist at baseline, 3 months and 6 months, and PT and OT every 2 weeks for maintenance neuro-rehabilitation.
Group II: Usual care groupActive Control1 Intervention
Receive usual care but will have study visit assessments at baseline and 6 months.
Tele-neurohub is already approved in United States for the following indications:
🇺🇸 Approved in United States as Tele-neurohub for:
- Lewy Body Dementia management
- Interdisciplinary care for neurodegenerative dementias
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. [2023]Lewy Body Disease (LBD) is the second most common neurodegenerative disorder. Despite high family caregiver strain and adverse patient and caregiver outcomes, few interventions exist for LBD family caregivers. Based on a successful peer mentoring pilot study in advanced Parkinson's Disease, we revised the curriculum of this peer-led educational intervention incorporating LBD caregiver input.
Lewy body dementia: caregiver burden and unmet needs. [2023]Lewy body dementia (LBD) is a common cause of dementia but to date, little is known about caregiver burden. The Lewy Body Dementia Association (www.LBDA.org) conducted a web-based survey of 962 caregivers (mean age 56 y; 88% women). The most common initial symptoms were cognitive (48%), motor (39%), or both (13%). Caregivers expressed concerns about fear of future (77%), feeling stressed (54%), loss of social life (52%), and uncertainty about what to do next (50%). Caregivers reported moderate-to-severe burden; 80% felt the people around them did not understand their burden and 54% reported feelings of isolation with spousal caregivers reporting more burden than nonspousal caregivers. Only 29% hired in-home assistance, whereas less than 40% used respite or adult day care, geriatric case managers, or attended a support group meeting. Lack of service utilization occurred despite two-thirds of caregivers reporting medical crises requiring emergency services, psychiatric care, or law enforcement. Caregivers reported preferences for web-based information, directories of LBD expert providers, information on LBD research, and location of local support groups. These findings highlight significant unmet needs for LBD caregivers and provide targets for intervention to reduce caregiver burden. Community resources such as the Lewy Body Dementia Association may serve this end, while also providing practical information and support for caregivers.
Causes and outcomes of hospitalization in Lewy body dementia: A retrospective cohort study. [2020]Understanding hospitalization in Lewy body dementia (LBD) is a known knowledge gap. We aimed to identify common causes, medication profiles, complications, and outcomes of hospitalization in LBD.
Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies. [2021]To synthesize the evidence across longitudinal studies comparing survival in dementia with Lewy bodies (DLB) and Alzheimer's disease (AD).
Costs During the Last Five Years of Life for Patients with Clinical and Pathological Confirmed Diagnosis of Lewy Body Dementia and Alzheimer's Disease. [2023]Little is known regarding healthcare expenditures for patients with dementia with Lewy bodies (DLB) during the end of life.
Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study. [2022]To investigate the safety and efficacy of long-term administration (52 weeks) of donepezil in patients with dementia with Lewy bodies (DLB).
Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. [2022]BACKGROUND Antidopaminergic medications, including antipsychotics, are known to worsen motor and neuropsychiatric symptoms, including cognition and psychosis, in patients with dementia with Lewy body (DLB). The intensity of worsened clinical symptoms may vary and can result in mortality in certain situations. There have been some reports supporting clozapine, quetiapine and pimavanserin use in psychosis control in this population. CASE REPORT We describe the case of 75-year-old man with diagnosis of DLB and the post-treatment outcome with olanzapine for psychosis during hospitalization. He experienced worsened cognitive and motor functions. Discontinuation of olanzapine resulted in resolution of the clinical worsening. Further, re-initiation of Pimavanserin helped treat his hallucinations. He returned back to his baseline during a follow-up visit in the clinic at 1 month after discharge. Further, we incorporated the use of Best Practice Alert (BPA) as a part of the electronic health record (EHR) system to help providers identify patients prone to neuroleptic sensitivity and help select appropriate medications to treat psychosis in this patient population. CONCLUSIONS Administration of antipsychotics in patients with parkinsonism, especially DLB, requires close clinical monitoring and judicious use. Awareness of morbidity and mortality associated with such use is of importance, especially during hospitalization. From our experience, we incorporated use of BPA, which can help providers make judicious choices while treating this patient population. Pimavanserin, which is FDA-approved for psychosis in Parkinson's disease, could be a potential safe and effective treatment option in this patient population.
Fact-finding survey on diagnostic procedures and therapeutic interventions for parkinsonism accompanying dementia with Lewy bodies. [2020]We performed a questionnaire survey of medical doctors engaged in the management of dementia to identify the actual status of treatment for dementia with Lewy bodies (DLB) in Japan.
Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. [2022]The term Lewy body dementia refers to either of two related diagnoses: dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD). Clinical management of Lewy body dementia is challenging. The current treatment options focus on relieving symptoms; no disease-modifying therapies are available. There are currently no US Food and Drug Administration (FDA) approved drugs for the treatment of DLB, and there are only a few for PDD. Cholinesterase inhibitors are shown to be beneficial in improving cognitive symptoms in Lewy body dementia. Rivastigmine was approved by the FDA to treat PDD. Donepezil was approved in Japan as a treatment for DLB. Levodopa may provide modest benefit in treating motor symptoms and zonisamide in adjunct to low-dose levodopa helps with parkinsonism. Treatment of autonomic symptoms are based on symptomatic treatment with off-label agents. Our main objective in this article is to present an overview of the current pharmacological options available to treat the clinical features of DLB and PDD. When evaluating the existing management options for Lewy body dementia, it is difficult to fully separate PDD from DLB. However, we have attempted to identify whether the cited studies include patients with PDD and/or DLB. Moreover, we have provided an overview of the current drug pipeline in Lewy body dementia. All currently active trials are in phase I or II and most are focused on disease modification rather than symptomatic treatment. Phase II trial results for neflamapimod show promising results. Due to heterogeneity of symptoms and underlying pathophysiology, there is a need for new biomarker strategies and improved definitions of outcome measures for Lewy body dementia drug trials.
New evidence on the management of Lewy body dementia. [2021]Dementia with Lewy bodies and Parkinson's disease dementia, jointly known as Lewy body dementia, are common neurodegenerative conditions. Patients with Lewy body dementia present with a wide range of cognitive, neuropsychiatric, sleep, motor, and autonomic symptoms. Presentation varies between patients and can vary over time within an individual. Treatments can address one symptom but worsen another, which makes disease management difficult. Symptoms are often managed in isolation and by different specialists, which makes high-quality care difficult to accomplish. Clinical trials and meta-analyses now provide an evidence base for the treatment of cognitive, neuropsychiatric, and motor symptoms in patients with Lewy body dementia. Furthermore, consensus opinion from experts supports the application of treatments for related conditions, such as Parkinson's disease, for the management of common symptoms (eg, autonomic dysfunction) in patients with Lewy body dementia. However, evidence gaps remain and future clinical trials need to focus on the treatment of symptoms specific to patients with Lewy body dementia.
Support and information needs following a diagnosis of dementia with Lewy bodies. [2017]There is a lack of knowledge regarding the information and support needs of people with dementia with Lewy bodies (DLB) and their families around the time of diagnosis.
Practical Treatment of Lewy Body Disease in the Clinic: Patient and Physician Perspectives. [2020]This article describes the practical considerations in the clinical medical treatment in dementia with Lewy body (DLB) patients. It is illustrated with the voice of a DLB sufferer and his wife. According to our experience, emanating from a 15 year collaboration between a doctor and a nurse at a memory clinic, there are several possible therapeutical entrances. However, the order in which the medication is introduced is of great importance to avoid aggravation of other DLB symptoms. We start the treatment with cholinesterase inhibitor and memantine, and; thereafter, we treat the most disturbing symptom. Thereafter, we consider if orthostatic hypotension is present and treat it. In the treatment of depression and anxiety it is beneficial to use agents affecting both noradrenalin and serotonin. Dysphagia may be lethal but can be improved with carbohydrate drinks. These and other aspects are commented upon from our experience and are also reflected in relation to studies evaluating the existing level of evidence.
Lewy Body Dementia: An Overview of Promising Therapeutics. [2023]Lewy body dementia (LBD) encompasses dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD). This article will emphasize potential disease-modifying therapies as well as investigative symptomatic treatments for non-motor symptoms including cognitive impairment and psychosis that can present a tremendous burden to patients with LBD and their caregivers.