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

Study Overview
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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.

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

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

Intervention / Treatment
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* Behavioral: Navigated Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life - AD (Alzheimer's Disease) | 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 | From baseline to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Care Utilization | 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. | From baseline to 60 months | 
| Change in Zarit Burden Interview (short version). | 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. | From baseline to 60 months | 
| Change in Patient Health Questionnaire 9 (PhQ-9). | An established 9-item measure administered to the caregiver. Higher scores represent more severe caregiver depression | From baseline to 60 months | 
| Change in Caregiver Self-Efficacy: 1-5 ordinal scale | A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy | From baseline to 60 months | 
| Time to Long Term Care Placement | Number of days post randomization until nursing home or assisted living placement, excluding temporary stays | From date of baseline survey to immediately following long term care placement, assessed up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic Clinical Trial, Family Caregivers, Patient Care Management