Care EcoSystem: Ochsner Health System

Completed

• Conditions: Dementia

• Registration Number: NCT03916718
• Lead Sponsor: Ochsner Health System

Brief Summary

1. To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.

2. To assess the effect of the Care Ecosystem program on health care cost and quality care quality as measured by primary outcome variables.

* Adapted from the Care Ecosystem, memory.ucsf.edu/Care-Ecosystem

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Status Verified: 2021-02
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Male or female ≥55 years of age at baseline

• Probable dementia diagnosis as evidenced by one or more of the following criteria:

  • Dementia listed on medical record problem list as of January 1, 2015 or later, or, in the opinion of the referring provider has dementia
  • Prescribed with any of the following: donepezil, memantine, galantamine HBR, rivastigmine, or tartrate; or, in the opinion of the referring provider, could take such medication

• Lives in community

Exclusion Criteria

• Documented history of Multiple Sclerosis, ALS, Traumatic Brain Injury, Huntington's Disease, Schizophrenia, Bipolar Disorder, or current Substance Abuse Disorder
• Lives in a nursing home or assisted living facility
• Unable to complete monthly telehealth or phone visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quick Dementia Rating Scale (QDRS)	through study completion, an average of 1 year	Construct: Dementia severity Sum total score Normal 0-1 Mild cognitive impairment 2-5 Mild dementia 6-12 Moderate dementia 13-20 Severe dementia 20-30
Quality of Life in Dementia (QUALI-DEM)	through study completion, an average of 1 year	Construct: Dementia patient quality of life Subscales Care Relationship (0-9) Positive Affect (0-12) Negative Affect (0-6) Restless Tense Behavior (0-9) Social Relations (0-9) Social Isolation (0-9); Higher scores= more of that behavior
Rate of ED and Hospital Admissions	through study completion, an average of 1 year	Cost
Zarit Caregiver Burden Scale- Short Form	through study completion, an average of 1 year	Construct: Family/Caregiver quality of life Sum total score 0-48, higher scores indicate more burden

Secondary Outcome Measures

Name	Time	Method
Rate of UTIs	through study completion, an average of 1 year
Rate of Falls	through study completion, an average of 1 year
Rate of medication change	through study completion, an average of 1 year

Trial Locations

Locations (1)

Ochsner Health System; 🇺🇸 New Orleans, Louisiana, United States