- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378245
Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations (TeleNH)
August 9, 2021 updated by: Richard Ronan Murphy
Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations and Healthcare Costs in Appalachia KY Skilled Nursing Facilities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University Of Kentucky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Dementia Care facility resident Problematic behavioral problems
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemedicine Intervention
Multidisciplinary telemedicine education of staff and providers on best practices for behavioral modification as well as education on best practices for pharmacologic therapies.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Neuropsychiatric Inventory (NPI) total score
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
Time Frame: 6 months
|
The RUD-FOCA records the care time in three areas: activities of daily living (ADL), instrumental activities of daily living (IADL) and supervision.
|
6 months
|
|
Change in Quality of Life in Alzheimers Dementia (QoL-AD)
Time Frame: 6 months.
|
13 quality of life items are rated on a four point scale, with 1 being poor and 4 being excellent.
Total scores range from 13 to 52.
It generally takes caregivers about 5 minutes to complete the measure.
|
6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
August 16, 2017
First Submitted That Met QC Criteria
December 17, 2017
First Posted (Actual)
December 19, 2017
Study Record Updates
Last Update Posted (Actual)
August 16, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0664-P3H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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