NCT05014971

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2022May 2026

First Submitted

Initial submission to the registry

August 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

June 26, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

August 13, 2021

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Satisfaction assessed by Patient Assessment of Communication of Telehealth questionnaire.

    6 months

  • Appropriateness assessed by Intervention Appropriateness Measure

    6 months

Study Arms (2)

Tele-neurohub

EXPERIMENTAL

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

Usual care group

ACTIVE COMPARATOR

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

Behavioral: Tele-neurohub

Interventions

Tele-neurohubBEHAVIORAL

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

Tele-neurohubUsual care group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseLewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDementiaNeurocognitive DisordersMental Disorders

Study Officials

  • Bhavana Patel, DO

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: tele-neurohub model of care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 20, 2021

Study Start

February 28, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

June 26, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations