45 and older, any sex, with Dementia or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 YearPrimary· 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
Group
Value
95% CI
Navigated Care
-1.43
± 5.64
Survey of Care
-1.12
± 5.87
Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One YearSecondary· 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.
Group
Value
95% CI
Navigated Care
.0483
± .703
Survey of Care
.175
± .840
Change in Caregiver Burden, Baseline to One YearSecondary· 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.
Group
Value
95% CI
Navigated Care
-1.682
± 8.144
Survey of Care
-1.482
± 8.641
Satisfaction With Dementia CareSecondary· 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.
Group
Value
95% CI
Navigated Care
148
Navigated Care
107
Navigated Care
57
Navigated Care
9
Change in Caregiver Depression, Baseline to One YearSecondary· Baseline to one year
Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.
Group
Value
95% CI
Navigated Care
-0.831
± 4.312
Survey of Care
-0.238
± 4.053
Change in Caregiver Self-efficacy, Baseline to One YearSecondary· 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.
Group
Value
95% CI
Navigated Care
1.356
± 3.038
Survey of Care
1.043
± 2.647
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04287738 — Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
· NA
· completed
Other recruiting trials for Dementia
Currently open trials in the same condition.
NCT07531589 — BrainLive Connect: Non-professional Delivered CST for People Living With Dementia
· NA
· recruiting
NCT07290387 — Tele-Savvy for Latino Caregivers
· NA
· recruiting
NCT06088810 — The Impact of Music Intervention on Sleep
· NA
· recruiting
NCT07482800 — Dementia in Fiction and Clinical Narratives
· recruiting
NCT07392944 — Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Home
· NA
· recruiting
Other University of California, San Francisco trials
Trials by the same sponsor.
NCT05284773 — Screening for Acute Malnutrition
· NA
· withdrawn
NCT04634851 — Video Home Visits for Dietary Counselling
· NA
· not yet recruiting
NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M
· Phase 1, PHASE2
· not yet recruiting
NCT07534098 — Intervention for Hearing Health Among Native Americans
· NA
· not yet recruiting
NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT)
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02213458.