NCT04287738

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 912 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Alzheimer Disease
• Dementia, Vascular
• Lewy Body Disease
• Frontotemporal Lobar Degeneration
• Memory Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Navigated Care	Telephone-based collaborative dementia care was delivered by a trained care team navigator, who provided education, support and care coordination with a team of dementia specialists (advanced practice nurse, social worker, and pharmacist). For more details, please see references below.

Timeline

• Start date: 2015-03-20
• Primary completion: 2022-05-20
• Completion: 2022-05-20
• First posted: 2020-02-27
• Last updated: 2023-11-18