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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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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