NCT03916588

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

August 16, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

April 10, 2019

Last Update Submit

September 9, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Mortality/Survival Rate

    through study completion, an average of 1 year

  • Quality of Life Scale (QoL)

    Neuropsychiatric/behavioral symptoms

    through study completion, an average of 1 year

  • Fall Incidence

    Neuropsychiatric/behavioral symptoms

    through study completion, an average of 1 year

  • Zarit Caregiver Burden

    Family burden

    through study completion, an average of 1 year

  • Patient Care Team Burden Scale (PCTB)

    staff caregiver burden

    through study completion, an average of 1 year

  • Healthcare Utilization

    Number of visits to hospital or clinic

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Fitbit Charge HR activity and sleep data

    through study completion, an average of 1 year

Study Arms (1)

Memory Care Unit Residents

Residents on a locked memory care unit in southeastern Louisiana will be enrolled. Engaged family members and staff will also consent to provide qualitative information on the resident.

Behavioral: Individualized Care Plan

Interventions

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

Memory Care Unit Residents

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents living on the memory care unit will have pre diagnosed advanced dementia or Alzheimer's disease. Subjects will have diminished or no capacity and will require a legally authorized representative.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • R. John Sawyer, PhD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 16, 2019

Study Start

August 16, 2018

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations