Completed

NCT Number: NCT04287738

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

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.

Completed

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia, Vascular Frontotemporal Lobar Degeneration Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Memory Disorders Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Synucleinopathies TDP-43 Proteinopathies Tauopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigated Care

Behavioral

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.

Primary outcomes

Change in Quality of Life - AD (Alzheimer's Disease)

Time frame: 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 outcomes

Change in Health Care Utilization

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

Centers for Medicare and Medicaid Services
National Institute on Aging (NIA)
University of Nebraska

Registry information

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Feb 27, 2020
Registry last updated: Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed