106 Participants Needed

Telehealth for Lewy Body Dementia

BP
NB
Overseen ByNoheli Bedenfield, MHA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.56789

Is Tele-neurohub a promising treatment for Lewy Body Dementia?

Yes, Tele-neurohub is a promising treatment for Lewy Body Dementia because it offers a way to manage the wide range of symptoms by providing virtual neurology care, which can help improve the quality of care for patients and support for caregivers.110111213

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.

Research Team

BP

Bhavana Patel, DO

Principal Investigator

University of Florida

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
See 5 more

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
Trial Overview The 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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

A peer mentor-led educational intervention for family caregivers of individuals with Lewy Body Disease (LBD) was found to be feasible and well-received, with 95.3% of calls rated as useful by participants.
The intervention significantly improved caregivers' knowledge about LBD by 13% and their attitudes towards dementia by 7%, demonstrating its effectiveness in supporting caregivers in managing their roles.
Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia.Fleisher, JE., Suresh, M., Levin, ME., et al.[2023]
A survey of 962 caregivers of individuals with Lewy body dementia revealed that 80% felt misunderstood in their burden, with many experiencing moderate-to-severe stress and isolation, particularly spousal caregivers.
Despite significant challenges, including medical crises, only 29% of caregivers sought in-home assistance, indicating a need for better access to resources and support services for LBD caregivers.
Lewy body dementia: caregiver burden and unmet needs.Galvin, JE., Duda, JE., Kaufer, DI., et al.[2023]
Patients diagnosed with dementia with Lewy bodies (DLB) have a significantly shorter average survival time of 4.11 years compared to 5.66 years for those with Alzheimer's disease (AD), indicating a difference of 1.60 years (p < 0.01).
The relative risk of death for individuals with DLB is 1.35 times higher than for those with AD (p < 0.01), highlighting the need for increased research and awareness regarding the prognosis of DLB.
Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies.Mueller, C., Soysal, P., Rongve, A., et al.[2021]

References

Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. [2023]
Lewy body dementia: caregiver burden and unmet needs. [2023]
Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies. [2021]
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]
Causes and outcomes of hospitalization in Lewy body dementia: A retrospective cohort study. [2020]
Fact-finding survey on diagnostic procedures and therapeutic interventions for parkinsonism accompanying dementia with Lewy bodies. [2020]
Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. [2022]
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]
Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. [2022]
New evidence on the management of Lewy body dementia. [2021]
Support and information needs following a diagnosis of dementia with Lewy bodies. [2017]
Practical Treatment of Lewy Body Disease in the Clinic: Patient and Physician Perspectives. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Lewy Body Dementia: An Overview of Promising Therapeutics. [2023]
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