Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
estimated completion
Principal Investigator
Katherine L Possin, Ph.D. (ucsf)
Photo of Katherine L Possin
Katherine L Possin

Description

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.

Keywords

Dementia Alzheimer Disease Dementia, Vascular Lewy Body Disease Frontotemporal Lobar Degeneration Memory Disorders Pragmatic Clinical Trial Family Caregivers Patient Care Management Navigated Care

Eligibility

For people ages 18 years and up

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

Lead Scientist at UC Health

  • Katherine L Possin, Ph.D. (ucsf)
    Associate Professor, Neurology. Authored (or co-authored) 71 research publications. Research interests: Neuropsychology · Diagnosis · Caregiving.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04287738
Study Type
Interventional
Last Updated