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

Not Applicable

Completed

• Conditions: Dementia; Memory Disorders; Dementia, Vascular; Frontotemporal Lobar Degeneration; Alzheimer Disease; Lewy Body Disease
• Interventions: Behavioral: Navigated Care

• Registration Number: NCT04287738
• Lead Sponsor: University of California, San Francisco

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-20
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 912

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigated Care	Navigated Care	Telephone-based collaborative dementia care navigation

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life - AD (Alzheimer's Disease)	From baseline to 60 months	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

Name	Time	Method
Change in Zarit Burden Interview (short version).	From baseline to 60 months	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.
Change in Health Care Utilization	From baseline to 60 months	Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. Measures number of times utilized, with higher scores indicating a worse outcome. To be confirmed using Medicare claims data.
Time to Long Term Care Placement	From date of baseline survey to immediately following long term care placement, assessed up to 60 months	Number of days post randomization until nursing home or assisted living placement, excluding temporary stays
Change in Caregiver Self-Efficacy: 1-5 ordinal scale	From baseline to 60 months	A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy
Change in Patient Health Questionnaire 9 (PhQ-9).	From baseline to 60 months	An established 9-item measure administered to the caregiver. Higher scores represent more severe caregiver depression