DementiaNCT03916718
Care EcoSystem: Ochsner Health System
An observational study of Dementia, run by Ochsner Health System at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Care EcoSystem
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population includes patients seen at Ochsner Clinic Foundation, >=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by >= 2 ED visits, >= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
- To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.
- 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
- Conditions
- Dementia
- Being tested
- Care EcoSystem
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care EcoSystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia | The target population includes patients seen at Ochsner Clinic Foundation, >=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by >= 2 ED visits, >= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan. Receives: Behavioral: Care EcoSystem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ED and Hospital Admissions
Cost
Measured: through study completion, an average of 1 year
Quick Dementia Rating Scale (QDRS)
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
Measured: through study completion, an average of 1 year
Quality of Life in Dementia (QUALI-DEM)
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
Measured: through study completion, an average of 1 year
Zarit Caregiver Burden Scale- Short Form
Construct: Family/Caregiver quality of life Sum total score 0-48, higher scores indicate more burden
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Rate of Falls
Measured: through study completion, an average of 1 year
Rate of UTIs
Measured: through study completion, an average of 1 year
Rate of medication change
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start26 Feb 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R. John Sawyer, PhD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916718
- Sponsor's protocol ID
- 2018241
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2019
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03916718
- Acronym / sponsor ID
- 2018241
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia | – | Behavioral: Care EcoSystemThe target population includes patients seen at Ochsner Clinic Foundation, >=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by >= 2 ED visits, >= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes patients seen at Ochsner Clinic Foundation, >=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by >= 2 ED visits, >= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.
Key inclusion criteria (5 listed)
- Male or female ≥55 years of age at baseline
- Probable dementia diagnosis as evidenced by one or more of the following criteria:
- Lives in community
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care EcoSystemThis 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. | Behavioural | Dementia |
Primary outcome
Rate of ED and Hospital Admissions
Time frame: through study completion, an average of 1 year
Cost
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
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
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
3 secondary outcomes
Rate of Falls
Time frame: through study completion, an average of 1 year
Rate of UTIs
Time frame: through study completion, an average of 1 year
Rate of medication change
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- UCSF Care EcosystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. John Sawyer, PhD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ED and Hospital Admissions (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.