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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03916588
Other study ID # 2018.078
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 16, 2018
Est. completion date December 31, 2020

Study information

Verified date September 2021
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.


Recruitment information / eligibility

Status Terminated
Enrollment 89
Est. completion date December 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Residents living in a specific locked memory care unit in Southeastern Louisiana or - Family or staff identified as part of the care team of the resident

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Individualized Care Plan
Medical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs

Locations

Country Name City State
United States Ochsner Health System New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality/Survival Rate through study completion, an average of 1 year
Primary Quality of Life Scale (QoL) Neuropsychiatric/behavioral symptoms through study completion, an average of 1 year
Primary Fall Incidence Neuropsychiatric/behavioral symptoms through study completion, an average of 1 year
Primary Zarit Caregiver Burden Family burden through study completion, an average of 1 year
Primary Patient Care Team Burden Scale (PCTB) staff caregiver burden through study completion, an average of 1 year
Primary Healthcare Utilization Number of visits to hospital or clinic through study completion, an average of 1 year
Secondary Fitbit Charge HR activity and sleep data Average daily steps, minutes asleep through study completion, an average of 1 year
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