Status:

COMPLETED

Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

University of Nebraska

National Institute on Aging (NIA)

Conditions:

Dementia

Alzheimer Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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 th...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 20 2015

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 20 2022

    Estimated Enrollment :

    912 Patients enrolled

    Trial Details

    Trial ID

    NCT04287738

    Start Date

    March 20 2015

    End Date

    May 20 2022

    Last Update

    November 18 2023

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