Telehealth in Lewy Body Dementia

Not Applicable

Recruiting

• Conditions: Lewy Body Dementia With Behavioral Disturbance; Lewy Body Disease; Lewy Body Parkinson Disease
• Interventions: Behavioral: Tele-neurohub

• Registration Number: NCT05014971
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-20
• Study Start: 2022-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care group	Tele-neurohub	Receive usual care but will have study visit assessments at baseline and 6 months.
Tele-neurohub	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Satisfaction assessed by Patient Assessment of Communication of Telehealth questionnaire.	6 months	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.
Appropriateness assessed by Intervention Appropriateness Measure	6 months	Appropriateness will be determined by the Intervention Appropriateness Measure, higher scores indicate greater appropriateness

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States