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Recruiting

NCT Number: NCT05014971

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Bhavana Patel, DO

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-neurohub

Behavioral

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

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Appropriateness assessed by Intervention Appropriateness Measure

    Time frame: 6 months

    Appropriateness will be determined by the Intervention Appropriateness Measure, higher scores indicate greater appropriateness

Study contacts

Contact information is provided by the study sponsor or research team.

Bhavana Patel, DO

CONTACT

[email protected]

352-733-2419

Noheli Bedenfield, MHA

CONTACT

[email protected]

352-733-2419

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2021
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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