Completed

NCT Number: NCT02213458

Care Ecosystem: Navigating Patients and Families Through Stages of Care

This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with 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 patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.

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

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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 either English, Cantonese, Mandarin, 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 either English, Cantonese, Mandarin, or Spanish
Caregiver is a legal adult

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 our trial
Patient is pregnant

Treatment and study plan

Navigated Care

Behavioral

Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).

Primary outcomes

Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year

Time frame: Baseline to one year

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 Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year

Time frame: Baseline to one year

Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.
Change in Caregiver Burden, Baseline to One Year

Time frame: Baseline to one year

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.
Satisfaction With Dementia Care

Time frame: One year

A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.
Change in Caregiver Depression, Baseline to One Year

Time frame: Baseline to one year

Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.
Change in Caregiver Self-efficacy, Baseline to One Year

Time frame: Baseline to one year

A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.

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

Official study title

University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Aug 11, 2014
Registry last updated: Feb 20, 2024

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.

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Completed