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Trial record 1 of 1 for:    NCT02213458
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Care Ecosystem: Navigating Patients and Families Through Stages of Care

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ClinicalTrials.gov Identifier: NCT02213458
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
University of Nebraska
Centers for Medicare and Medicaid Services
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE March 20, 2015
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Quality of Life-AD [ Time Frame: One 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • Satisfaction with Care [ Time Frame: Two years or at study completion, whichever is first ]
    Modification of Satisfaction with Care at the End of Life in Dementia (SWC-EOLD), a 10-item scale reworded to present tense rather than past tense
  • Zarit Burden Interview [ Time Frame: Two years or study completion, whichever is earliest ]
    A measure of family caregiver burden
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Health care utilization [ Time Frame: 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.
  • Caregiver burden [ Time Frame: 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 [ Time Frame: One year ]
    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.
  • Caregiver depression [ Time Frame: One year ]
    Patient Health Questionnaire 9 (PhQ-9). Higher scores represent more severe depression.
  • Caregiver self-efficacy [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Total Cost of Care [ Time Frame: Cumulative ]
Total Cost Index is a measure of a primary care provider's risk-adjusted cost-effectiveness at managing the population they care for.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Care Ecosystem: Navigating Patients and Families Through Stages of Care
Official Title  ICMJE University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Dementia
  • Alzheimer Disease
  • Dementia, Vascular
  • Lewy Body Disease
  • Frontotemporal Lobar Degeneration
  • Memory Disorders
Intervention  ICMJE Behavioral: Navigated Care
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).
Study Arms  ICMJE
  • Experimental: Navigated Care
    Comprehensive longitudinal continuing care program
    Intervention: Behavioral: Navigated Care
  • No Intervention: Survey of Care
    Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Publications * 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 Sep 30. doi: 10.1001/jamainternmed.2019.4101. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2017)
780
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
2100
Actual Study Completion Date  ICMJE March 8, 2018
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

This study will enroll patients as well as their primary caregivers as research participants.

Inclusion criteria for patient participants:

  1. Patient has a diagnosis of dementia with a progressive course
  2. Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
  3. Patient is covered by Medicare or Medi-caid or is Medi-pending
  4. 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
  5. Patient speaks either English, Cantonese, Mandarin, or Spanish
  6. Patient lives in California or Nebraska or Iowa
  7. Patient is age 45 or older

Inclusion criteria for caregiver participants:

  1. Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
  2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish
  3. Caregiver is a legal adult

Exclusion Criteria:

  1. Patient resides in a nursing home or skilled nursing facility at time of enrollment
  2. Participant is enrolled in a similar clinical trial that precludes their participation in our trial
  3. Patient is pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213458
Other Study ID Numbers  ICMJE 1C12013003302
5R01AG056715 ( U.S. NIH Grant/Contract )
1C1CMS331346 ( Other Grant/Funding Number: Centers for Medicare and Medicaid Services )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of Nebraska
  • Centers for Medicare and Medicaid Services
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Katherine L Possin, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP