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

Status: Active, not recruiting
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

• 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

Time Frame
Start Date: March 20, 2015
Estimated Completion Date: March 5, 2024
Participants
Target number of participants: 912
Treatments
Experimental: Navigated Care
Telephone-based collaborative dementia care navigation
No Intervention: Survey of Care
Control group that will receive usual care and undergo the same regular assessments as patients enrolled in Navigated Care
Authors
Katherine L Possin
Sponsors
Collaborators: National Institute on Aging (NIA), University of Nebraska, Centers for Medicare and Medicaid Services
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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