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

November 15, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

912

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 60 months
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.
From baseline to 60 months
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
From baseline to 60 months
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
From baseline to 60 months
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
From date of baseline survey to immediately following long term care placement, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Investigators

  • Principal Investigator: Katherine L Possin, Ph.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2015

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AG056715-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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