Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial (NCT04287738) | Clinical Trial Compass
CompletedNot Applicable
Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
912 participantsStarted 2015-03-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Quality of Life - AD (Alzheimer's Disease)