Lewy Body Dementia With Behavioral DisturbanceNCT05014971
Telehealth in Lewy Body Dementia
A study testing Tele-neurohub in people with Lewy Body Dementia With Behavioral Disturbance and Lewy Body Parkinson Disease, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lewy Body Dementia With Behavioral Disturbance, Lewy Body Parkinson Disease, Lewy Body Disease
- What is being tested?
- Tele-neurohub
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Stakeholder Engagement for Interdisciplinary 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.
Read the 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.
- Conditions
- Lewy Body Dementia With Behavioral Disturbance, Lewy Body Parkinson Disease, Lewy Body Disease
- Being tested
- Tele-neurohub
- Medical subject headings
- Parkinson Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-neurohubBehavioural
Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tele-neurohub |
| Usual care group | Active comparator | Receive usual care but will have study visit assessments at baseline and 6 months. Receives: Behavioral: Tele-neurohub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed tele-health visits
Feasibility will be determined by completion of at least 75% telehealth visits by the intervention cohort
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Appropriateness assessed by Intervention Appropriateness Measure
Appropriateness will be determined by the Intervention Appropriateness Measure, higher scores indicate greater appropriateness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start28 Feb 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body Dementia With Behavioral DisturbanceStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- tele-neurohub model of care
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Bhavana Patel, DO, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014971
- Sponsor's protocol ID
- IRB202001625
- Other IDs
- K23AG073575, PRO00033145
- Status last verified
- Jun 2026
- First submitted
- 13 Aug 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia
- ClinicalTrials.gov ID
- NCT05014971
- Acronym / sponsor ID
- IRB202001625
- Conditions
- Lewy Body Dementia With Behavioral Disturbance, Lewy Body Parkinson Disease, Lewy Body Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- tele-neurohub model of care
| Arm | Type | Receives |
|---|---|---|
| Tele-neurohub | Experimental | Behavioral: Tele-neurohubThis 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. |
| Usual care group | Active comparator | Behavioral: Tele-neurohubReceive usual care but will have study visit assessments at baseline and 6 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-neurohubInterdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician. | Behavioural | Tele-neurohub, Usual care group |
Primary outcome
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
2 secondary outcomes
Satisfaction assessed by Patient Assessment of Communication of Telehealth questionnaire.
Time frame: 6 months
Appropriateness assessed by Intervention Appropriateness Measure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Lewy Body Dementia With Behavioral Disturbance
RecruitingObservational study
Parkinson's Disease and Movement Disorders Clinical Database
Parkinson Disease, Parkinson Disease Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavana Patel, DO principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-neurohub in people with Lewy Body Dementia With Behavioral Disturbance and Lewy Body Parkinson Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of completed tele-health visits (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.