Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
Primary Purpose
Dementia, Alzheimer Disease, Dementia, Vascular
Status
Active
Phase
Not Applicable
Locations
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 English, Cantonese, 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 English, Cantonese, or Spanish
- Caregiver is a legal adult
- Zarit-12 caregiver burden score greater than or equal to 17 at pre-randomization (baseline); this criteria is specific to this extension trial
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 the investigator's trial
- Patient is pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Navigated Care
Survey of Care
Arm Description
Telephone-based collaborative dementia care navigation
Control group that will receive usual care and undergo the same regular assessments as patients enrolled in Navigated Care
Outcomes
Primary Outcome Measures
Change in Quality of Life - AD (Alzheimer's Disease)
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 Health Care Utilization
Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. Measures number of times utilized, with higher scores indicating a worse outcome. To be confirmed using Medicare claims data.
Change in 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.
Change in Patient Health Questionnaire 9 (PhQ-9).
An established 9-item measure administered to the caregiver. Higher scores represent more severe caregiver depression
Change in Caregiver Self-Efficacy: 1-5 ordinal scale
A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy
Time to Long Term Care Placement
Number of days post randomization until nursing home or assisted living placement, excluding temporary stays
Full Information
NCT ID
NCT04287738
First Posted
January 24, 2020
Last Updated
October 31, 2022
Sponsor
University of California, San Francisco
Collaborators
University of Nebraska, National Institute on Aging (NIA), Centers for Medicare and Medicaid Services
1. Study Identification
Unique Protocol Identification Number
NCT04287738
Brief Title
Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
Official Title
Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
March 5, 2024 (Anticipated)
Study Completion Date
March 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Nebraska, National Institute on Aging (NIA), Centers for Medicare and Medicaid Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an extension trial of a prior trial (NCT02213458). Both persons with dementia (PWD) and their caregivers were enrolled as dyads. The purpose of this randomized clinical trial is to evaluate the benefits of a program that supports model care for PWD and their caregivers. Whereas the prior trial only delivered care and examined outcomes up to 12-months, this trial extends care and outcome measurement for 5 years or until death, and includes all dyads where the caregiver reported high caregiver burden (Zarit-12 greater than or equal to 17) at pre-randomization baseline for the original trial. Participants were recruited from California, Nebraska and Iowa. Participants determined to be eligible were consented and randomized into one of two groups. Two thirds of dyads were enrolled into Navigated Care that provided them with phone-based 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 dyads were enrolled to a control group, entitled Survey of Care. Outcomes were unchanged from the original trial except for the addition of time to long term care placement and are detailed below.
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
912 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navigated Care
Arm Type
Experimental
Arm Description
Telephone-based collaborative dementia care navigation
Arm Title
Survey of Care
Arm Type
No Intervention
Arm Description
Control group that will receive usual care and undergo the same regular assessments as patients enrolled in Navigated Care
Intervention Type
Behavioral
Intervention Name(s)
Navigated Care
Intervention Description
Telephone-based collaborative dementia care was delivered by a trained care team navigator, who provided education, support and care coordination with a team of dementia specialists (advanced practice nurse, social worker, and pharmacist). For more details, please see references below.
Primary Outcome Measure Information:
Title
Change in Quality of Life - AD (Alzheimer's Disease)
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
From baseline to 60 months
Secondary Outcome Measure Information:
Title
Change in Health Care Utilization
Description
Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. Measures number of times utilized, with higher scores indicating a worse outcome. To be confirmed using Medicare claims data.
Time Frame
From baseline to 60 months
Title
Change in Zarit Burden Interview (short version).
Description
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
From baseline to 60 months
Title
Change in Patient Health Questionnaire 9 (PhQ-9).
Description
An established 9-item measure administered to the caregiver. Higher scores represent more severe caregiver depression
Time Frame
From baseline to 60 months
Title
Change in Caregiver Self-Efficacy: 1-5 ordinal scale
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
Time Frame
From baseline to 60 months
Title
Time to Long Term Care Placement
Description
Number of days post randomization until nursing home or assisted living placement, excluding temporary stays
Time Frame
From date of baseline survey to immediately following long term care placement, assessed up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 English, Cantonese, 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 English, Cantonese, or Spanish
Caregiver is a legal adult
Zarit-12 caregiver burden score greater than or equal to 17 at pre-randomization (baseline); this criteria is specific to this extension trial
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 the investigator's trial
Patient is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Possin, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
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
result
PubMed Identifier
28323819
Citation
Possin KL, Merrilees J, Bonasera SJ, Bernstein A, Chiong W, Lee K, Wilson L, Hooper SM, Dulaney S, Braley T, Laohavanich S, Feuer JE, Clark AM, Schaffer MW, Schenk AK, Heunis J, Ong P, Cook KM, Bowhay AD, Gearhart R, Chodos A, Naasan G, Bindman AB, Dohan D, Ritchie C, Miller BL. Development of an adaptive, personalized, and scalable dementia care program: Early findings from the Care Ecosystem. PLoS Med. 2017 Mar 21;14(3):e1002260. doi: 10.1371/journal.pmed.1002260. eCollection 2017 Mar.
Results Reference
result
PubMed Identifier
31175026
Citation
Chen Y, Wilson L, Kornak J, Dudley RA, Merrilees J, Bonasera SJ, Byrne CM, Lee K, Chiong W, Miller BL, Possin KL. The costs of dementia subtypes to California Medicare fee-for-service, 2015. Alzheimers Dement. 2019 Jul;15(7):899-906. doi: 10.1016/j.jalz.2019.03.015. Epub 2019 Jun 4.
Results Reference
result
PubMed Identifier
30497302
Citation
Merrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. Dementia (London). 2020 Aug;19(6):1955-1973. doi: 10.1177/1471301218814121. Epub 2018 Nov 29.
Results Reference
result
PubMed Identifier
31282955
Citation
Guterman EL, Allen IE, Josephson SA, Merrilees JJ, Dulaney S, Chiong W, Lee K, Bonasera SJ, Miller BL, Possin KL. Association Between Caregiver Depression and Emergency Department Use Among Patients With Dementia. JAMA Neurol. 2019 Oct 1;76(10):1166-1173. doi: 10.1001/jamaneurol.2019.1820.
Results Reference
result
PubMed Identifier
31044411
Citation
Bernstein A, Rogers KM, Possin KL, Steele NZR, Ritchie CS, Miller BL, Rankin KP. Primary Care Provider Attitudes and Practices Evaluating and Managing Patients with Neurocognitive Disorders. J Gen Intern Med. 2019 Sep;34(9):1691-1692. doi: 10.1007/s11606-019-05013-7. No abstract available.
Results Reference
result
PubMed Identifier
31317539
Citation
Rosa TD, Possin KL, Bernstein A, Merrilees J, Dulaney S, Matuoka J, Lee KP, Chiong W, Bonasera SJ, Harrison KL, Kahn JG. Variations in Costs of a Collaborative Care Model for Dementia. J Am Geriatr Soc. 2019 Dec;67(12):2628-2633. doi: 10.1111/jgs.16076. Epub 2019 Jul 18.
Results Reference
result
PubMed Identifier
31322558
Citation
Bernstein A, Harrison KL, Dulaney S, Merrilees J, Bowhay A, Heunis J, Choi J, Feuer JE, Clark AM, Chiong W, Lee K, Braley TL, Bonasera SJ, Ritchie CS, Dohan D, Miller BL, Possin KL. The Role of Care Navigators Working with People with Dementia and Their Caregivers. J Alzheimers Dis. 2019;71(1):45-55. doi: 10.3233/JAD-180957.
Results Reference
result
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Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
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