Back to resultsCare Ecosystem: Navigating Patients and Families Through Stages of Care
Primary Purpose
Dementia, Alzheimer Disease, Dementia, Vascular
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigated Care
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Pragmatic Clinical Trial, Family Caregivers, Patient Care Management
Eligibility Criteria
This study will enroll patients as well as their primary caregivers as research participants.
Inclusion criteria for patient participants:
- Patient has a diagnosis of dementia with a progressive course
- Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
- Patient is covered by Medicare or Medi-caid or is Medi-pending
- Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review
- Patient speaks either English, Cantonese, Mandarin, or Spanish
- Patient lives in California or Nebraska or Iowa
- Patient is age 45 or older
Inclusion criteria for caregiver participants:
- Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
- Caregiver speaks either English, Cantonese, Mandarin, or Spanish
- Caregiver is a legal adult
Exclusion Criteria:
- Patient resides in a nursing home or skilled nursing facility at time of enrollment
- Participant is enrolled in a similar clinical trial that precludes their participation in our trial
- Patient is pregnant
Sites / Locations
- University of California, San Francisco
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Navigated Care
Survey of Care
Arm Description
Comprehensive longitudinal continuing care program
Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Outcomes
Primary Outcome Measures
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life
Secondary Outcome Measures
Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year
Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.
Change in Caregiver Burden, Baseline to One Year
Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.
Satisfaction With Dementia Care
A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.
Change in Caregiver Depression, Baseline to One Year
Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.
Change in Caregiver Self-efficacy, Baseline to One Year
A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.
Full Information
NCT ID
NCT02213458
First Posted
August 7, 2014
Last Updated
August 13, 2021
Sponsor
University of California, San Francisco
Collaborators
University of Nebraska, Centers for Medicare and Medicaid Services, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02213458
Brief Title
Care Ecosystem: Navigating Patients and Families Through Stages of Care
Official Title
University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
March 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Nebraska, Centers for Medicare and Medicaid Services, National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Frontotemporal Lobar Degeneration, Memory Disorders
Keywords
Pragmatic Clinical Trial, Family Caregivers, Patient Care Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navigated Care
Arm Type
Experimental
Arm Description
Comprehensive longitudinal continuing care program
Arm Title
Survey of Care
Arm Type
No Intervention
Arm Description
Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Intervention Type
Behavioral
Intervention Name(s)
Navigated Care
Intervention Description
Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).
Primary Outcome Measure Information:
Title
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
Description
An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life
Time Frame
Baseline to one year
Secondary Outcome Measure Information:
Title
Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year
Description
Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.
Time Frame
Baseline to one year
Title
Change in Caregiver Burden, Baseline to One Year
Description
Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.
Time Frame
Baseline to one year
Title
Satisfaction With Dementia Care
Description
A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.
Time Frame
One year
Title
Change in Caregiver Depression, Baseline to One Year
Description
Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.
Time Frame
Baseline to one year
Title
Change in Caregiver Self-efficacy, Baseline to One Year
Description
A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.
Time Frame
Baseline to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
This study will enroll patients as well as their primary caregivers as research participants.
Inclusion criteria for patient participants:
Patient has a diagnosis of dementia with a progressive course
Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
Patient is covered by Medicare or Medi-caid or is Medi-pending
Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review
Patient speaks either English, Cantonese, Mandarin, or Spanish
Patient lives in California or Nebraska or Iowa
Patient is age 45 or older
Inclusion criteria for caregiver participants:
Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
Caregiver speaks either English, Cantonese, Mandarin, or Spanish
Caregiver is a legal adult
Exclusion Criteria:
Patient resides in a nursing home or skilled nursing facility at time of enrollment
Participant is enrolled in a similar clinical trial that precludes their participation in our trial
Patient is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Possin, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31566651
Citation
Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.
Results Reference
derived
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Care Ecosystem: Navigating Patients and Families Through Stages of Care
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