NCT03378245

Brief Summary

The purpose of this study is to investigate the use of telemedicine-based intervention at urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to residents with dementia who are at risk for unnecessary hospitalization due behavioral or neuropsychiatric symptoms and/or complications as well as caregivers and facility staff. The multidisciplinary team is comprised of trained behavioral neurologists, social workers, advanced practice providers, primary medical team and nurse coordinators.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

6.9 years

First QC Date

August 16, 2017

Last Update Submit

August 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the Neuropsychiatric Inventory (NPI) total score

    The NPI assesses 10 behavioral symptom domains, scoring is based on symptom frequency and severity. The total NPI score sums the products of frequency and severity scores for each domain. Higher scores indicate more behavioral disturbance

    6 months

Secondary Outcomes (2)

  • Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)

    6 months

  • Change in Quality of Life in Alzheimers Dementia (QoL-AD)

    6 months.

Study Arms (1)

Telemedicine Intervention

EXPERIMENTAL

Multidisciplinary telemedicine education of staff and providers on best practices for behavioral modification as well as education on best practices for pharmacologic therapies.

Behavioral: Behavioral modification and education on pharmacologic treatments.

Interventions

Education and counseling of care-giving staff on behavioral modification strategies, as well as education about current standard of care best practices for pharmacologic interventions.

Telemedicine Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dementia Care facility resident Problematic behavioral problems

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseProblem Behavior

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

August 16, 2017

First Posted

December 19, 2017

Study Start

September 1, 2013

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations