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Completed

NCT Number: NCT03916718

Care EcoSystem: Ochsner Health System

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care Ecosystem

Behavioral

This is a care management program and health care outcomes feasibility study utilizing the dementia Care Ecosystem (CE) program developed at UCSF and tailored to high need Ochsner PWD (patient with dementia) and their CGs (caregivers). Dyads (CGs and PWD) will receive a tailored clinical assessment addressing dementia severity, PWD and CG needs, education/strategies to management common dementia issues, medical issues and medication reconciliation, caregiver wellness strategies, linkages to community-based resources, advance care planning, education about the risk of ED and hospitalization, and care coordination with other specialties. Dyads will be followed on a monthly basis to monitor needs, provide support, and problem solve issues.

Primary outcomes

  1. Rate of ED and Hospital Admissions

    Time frame: through study completion, an average of 1 year

    Cost

  2. Quick Dementia Rating Scale (QDRS)

    Time frame: 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

  3. Quality of Life in Dementia (QUALI-DEM)

    Time frame: 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

  4. Zarit Caregiver Burden Scale- Short Form

    Time frame: 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 outcomes

  1. Rate of Falls

    Time frame: through study completion, an average of 1 year

  2. Rate of UTIs

    Time frame: through study completion, an average of 1 year

  3. Rate of medication change

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Registry information

Official study title

The Dementia Care EcoSystem: The Feasibility of a Care Management Program Addressing Healthcare Quality, Access, and Cost for Patients With Dementia and Their Caregivers

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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