Telehealth in Lewy Body Dementia

Lewy Body Disease Clinical Trial

Official title:

Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014971
• Other study ID #: IRB202001625
• Secondary ID: K23AG073575PRO00
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2023
• Source: University of Florida
• Contact: Bhavana Patel, DO
• Phone: 352-294-5400
• Email: bhavana.patel[@]neurology.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Healthcare Professional Inclusion Criteria:

• > 1 year of experience with LBD
• Willingness to participate in the study
• Fluency in English

Related Conditions & MeSH terms

• Dementia
• Lewy Body Dementia With Behavioral Disturbance
• Lewy Body Disease
• Parkinson Disease
• Problem Behavior

Intervention

Behavioral:
• Tele-neurohub
Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Appropriateness assessed by Intervention Appropriateness Measure	Appropriateness will be determined by the Intervention Appropriateness Measure, higher scores indicate greater appropriateness	6 months