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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

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Dementia, Vascular Lewy Body Disease Frontotemporal Lobar Degeneration Memory Disorders Behavioral: Navigated Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
Actual Study Start Date : March 20, 2015
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 8, 2018


Arm Intervention/treatment
Experimental: Navigated Care
Comprehensive longitudinal continuing care program
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).

No Intervention: Survey of Care
Control group that will undergo the same regular assessments as patients enrolled in Navigated Care



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Caregiver depression [ Time Frame: One year ]
    Patient Health Questionnaire 9 (PhQ-9). Higher scores represent more severe depression.

  5. 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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213458


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of California, San Francisco
University of Nebraska
Centers for Medicare and Medicaid Services
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Katherine L Possin, PhD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02213458     History of Changes
Other Study ID Numbers: 1C12013003302
5R01AG056715 ( U.S. NIH Grant/Contract )
1C1CMS331346 ( Other Grant/Funding Number: Centers for Medicare and Medicaid Services )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Keywords provided by University of California, San Francisco:
Pragmatic Clinical Trial
Family Caregivers
Patient Care Management
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Memory Disorders
Frontotemporal Lobar Degeneration
Lewy Body Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases