Telehealth in Lewy Body Dementia

NCT ID: NCT05014971

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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The purpose of this study is to convert an in-person patient-centric interdisciplinary care model to a virtual platform using stakeholder engagement from individuals with LBD, their caregivers and healthcare providers. Subsequently researchers will conduct a prospective, randomized, controlled pilot study implementing the virtual stakeholder developed interdisciplinary care model (tele-neurohub) for 6 month and assess the implementation outcomes of feasibility, acceptability, and appropriateness of the tele-neurohub model. The research goal is to establish and iteratively improve a virtual interdisciplinary model of care allowing patients with LBD and their caregivers to access sub-specialty care from their home.

Conditions

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Lewy Body Dementia With Behavioral Disturbance Lewy Body Parkinson Disease Lewy Body Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

tele-neurohub model of care
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Tele-neurohub

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 Type EXPERIMENTAL

Tele-neurohub

Intervention Type BEHAVIORAL

Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.

Usual care group

Receive usual care but will have study visit assessments at baseline and 6 months.

Group Type ACTIVE_COMPARATOR

Tele-neurohub

Intervention Type BEHAVIORAL

Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.

Interventions

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Tele-neurohub

Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* LBD diagnosis by a dementia or movement disorders specialist
* Clinician-determined mild-moderate dementia severity
* Internet access with a Zoom-compatible device
* Caregiver who resides in the patient's home and is willing to participate
* Fluency in English
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhavana Patel, DO

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bhavana Patel, DO

Role: CONTACT

352-733-2419

Noheli Bedenfield, MHA

Role: CONTACT

352-733-2419

Other Identifiers

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K23AG073575

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00033145

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202001625

Identifier Type: -

Identifier Source: org_study_id

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