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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-20

Study Completion Date

2022-05-20

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Navigated Care

Telephone-based collaborative dementia care navigation

Group Type EXPERIMENTAL

Navigated Care

Intervention Type 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.

Survey of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No