Care Ecosystem: Navigating Patients and Families Through Stages of Care

Not Applicable

Completed

• Conditions: Dementia; Memory Disorders; Lewy Body Disease; Frontotemporal Lobar Degeneration; Alzheimer Disease; Dementia, Vascular
• Interventions: Behavioral: Navigated Care

• Registration Number: NCT02213458
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-11
• Study Start: 2015-03-20
• Primary Completion: 2018-03-08
• Study Completion: 2018-03-08
• Results First Submitted: 2021-07-20
• Results First Submitted QC: 2021-08-13
• Results First Posted: 2021-09-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1560

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Patient resides in a nursing home or skilled nursing facility at time of enrollment
2. Participant is enrolled in a similar clinical trial that precludes their participation in our trial
3. Patient is pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigated Care	Navigated Care	Comprehensive longitudinal continuing care program

Primary Outcome Measures

Name	Time	Method
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year	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 Outcome Measures

Name	Time	Method
Change in Caregiver Self-efficacy, Baseline to One Year	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.
Change in Caregiver Depression, Baseline to One Year	Baseline to one year	Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.
Satisfaction With Dementia Care	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 Reported Rate of Emergency Department Utilization: Baseline to One Year	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	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.

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States