N/A
N=1,560
Care Ecosystem: Navigating Patients and Families Through Stages of Care
Dementia · Alzheimer Disease · Dementia, Vascular · Lewy Body Disease · Frontotemporal Lobar Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02213458 ↗Enrolled (actual)
1,560
Serious AEs
26.4%
Results posted
Sep 2021
Primary outcome: Primary: Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year — -1.43; -1.12 units on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Navigated Care (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year |
-1.43; -1.12 | 0.04 sig |
| SECONDARY Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year |
.0483; .175 | .05 |
| SECONDARY Change in Caregiver Burden, Baseline to One Year |
-1.682; -1.482 | 0.07 |
| SECONDARY Satisfaction With Dementia Care |
148; 107; 57; 9; 4 | — |
| SECONDARY Change in Caregiver Depression, Baseline to One Year |
-0.831; -0.238 | 0.03 sig |
| SECONDARY Change in Caregiver Self-efficacy, Baseline to One Year |
1.356; 1.043 | 0.11 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02213458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.