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

Sponsor

University of California, San Francisco (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04287738

Collaborator

University of Nebraska (Other), National Institute on Aging (NIA) (NIH), Centers for Medicare and Medicaid Services (U.S. Fed)

912

Enrollment

Arms

86.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease Dementia, Vascular Lewy Body Disease Frontotemporal Lobar Degeneration Memory Disorders	Behavioral: Navigated Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

912 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 20, 2015

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Navigated Care Telephone-based collaborative dementia care navigation	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.
No Intervention: Survey of Care Control group that will receive usual care and undergo the same regular assessments as patients enrolled in Navigated Care

Arm

Intervention/Treatment

Experimental: Navigated Care

Telephone-based collaborative dementia care navigation

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.

No Intervention: Survey of Care

Control group that will receive usual care and undergo the same regular assessments as patients enrolled in Navigated Care

Outcome Measures

Primary Outcome Measures

Change in Quality of Life - AD [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

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.
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 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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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