Care Ecosystem: Navigating Patients and Families Through Stages of Care
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|ClinicalTrials.gov Identifier: NCT02213458|
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : September 9, 2021
Last Update Posted : September 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease Dementia, Vascular Lewy Body Disease Frontotemporal Lobar Degeneration Memory Disorders||Behavioral: Navigated Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem|
|Actual Study Start Date :||March 20, 2015|
|Actual Primary Completion Date :||March 8, 2018|
|Actual Study Completion Date :||March 8, 2018|
Experimental: Navigated Care
Comprehensive longitudinal continuing care program
Behavioral: Navigated Care
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).
No Intervention: Survey of Care
Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213458
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Katherine L Possin, PhD||University of California, San Francisco|