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Clinical Trials/NCT05014971
NCT05014971Active, not recruitingNot Applicable

Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia

University of Florida2 sites in 1 country106 target enrollmentStarted: February 28, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
106
Locations
2
Primary Endpoint
Number of completed tele-health visits

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Usual care group

Active Comparator

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

Intervention: Tele-neurohub (Behavioral)

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.

Intervention: Tele-neurohub (Behavioral)

Outcomes

Primary Outcomes

Number of completed tele-health visits

Time Frame: 6 months

Feasibility will be determined by completion of at least 75% telehealth visits by the intervention cohort

Secondary Outcomes

  • Satisfaction assessed by Patient Assessment of Communication of Telehealth questionnaire.(6 months)
  • Appropriateness assessed by Intervention Appropriateness Measure(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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