Telehealth in Lewy Body Dementia

Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia

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.

Study Overview

• Status: Recruiting
• Conditions: Lewy Body Dementia With Behavioral Disturbance; Lewy Body Parkinson Disease; Lewy Body Disease
• Intervention / Treatment: Behavioral: Tele-neurohub

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noheli Bedenfield, MHA; Phone Number: 352-733-2419; Email: noheli.bedenfield@neurology.ufl.edu
• Study Contact Backup: Name: Bhavana Patel, DO; Phone Number: 352-733-2419; Email: bhavana.patel@neurology.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Bhavana Patel, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Participant with Lewy Body Dementia (LBD) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Tele-neurohub; Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.
Active Comparator: Usual care group; Receive usual care but will have study visit assessments at baseline and 6 months.	Behavioral: Tele-neurohub; Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of completed tele-health visits	Feasibility will be determined by completion of at least 75% telehealth visits by the intervention cohort	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction assessed by Patient Assessment of Communication of Telehealth questionnaire.	Acceptability will be determined by at least 80% of dyads reporting being "satisfied" or "highly satisfied" on the Patient Assessment of Communication of Telehealth questionnaire.	6 months
Appropriateness assessed by Intervention Appropriateness Measure	Appropriateness will be determined by the Intervention Appropriateness Measure, higher scores indicate greater appropriateness	6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Bhavana Patel, DO, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Problem Behavior; Parkinson Disease; Dementia; Lewy Body Disease
• Other Study ID Numbers: IRB202001625; K23AG073575 (U.S. NIH Grant/Contract); PRO00033145 (Other Identifier: UF UFIRST)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No