Trial · NCT02213458
Care Ecosystem: Navigating Patients and Families Through Stages of Care
NCT02213458, Not applicable, Completed, University of California, San Francisco; results first posted 2021-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Care Ecosystem: Navigating Patients and Families Through Stages of Care. Trials, record NCT02213458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02213458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Care Ecosystem: Navigating Patients and Families Through Stages of Care
- NCT number
- NCT02213458
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,560 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Dementia, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Frontotemporal Lobar Degeneration, Memory Disorders
- Interventions
- Navigated Care
- First posted
- 2014-08-11
- Last updated
- 2024-02-20
- Results first posted
- 2021-09-09
- Limitations and caveats
The economic outcomes are not reported beyond 12-month follow-up and were based only on survey data. Our sample likely differs in important ways from samples from similar programs that do not have a randomized control condition. During our recruitment and consent process, the only potential benefit communicated to prospective enrollees was that participation might inform and advance the quality of care provided to patients with dementia (PWDs) and their caregivers in the future.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year | Baseline to one year | The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months | units on a scale | MEAN |
| SECONDARY | Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year | Baseline to one year | Subset of patients with complete data on QDRS and emergency department visits at baseline | number of encounters | MEAN |
| SECONDARY | Change in Caregiver Burden, Baseline to One Year | Baseline to one year | Subset of patients with complete data on QDRS and Zarit burden at baseline | score on a scale | MEAN |
| SECONDARY | Satisfaction With Dementia Care | One year | Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Caregiver Depression, Baseline to One Year | Baseline to one year | score on a scale | MEAN | |
| SECONDARY | Change in Caregiver Self-efficacy, Baseline to One Year | Baseline to one year | Dyads with baseline data on dementia severity (QDRS) and self-efficacy | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year | Navigated Care | -1.43 | Standard Deviation 5.64 | units on a scale | |
| Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year | Survey of Care | -1.12 | Standard Deviation 5.87 | units on a scale | |
| Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year | Navigated Care | .0483 | Standard Deviation .703 | number of encounters | |
| Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year | Survey of Care | .175 | Standard Deviation .840 | number of encounters | |
| Change in Caregiver Burden, Baseline to One Year | Navigated Care | -1.682 | Standard Deviation 8.144 | score on a scale | |
| Change in Caregiver Burden, Baseline to One Year | Survey of Care | -1.482 | Standard Deviation 8.641 | score on a scale | |
| Satisfaction With Dementia Care | Navigated Care | Very satisfied with Care Ecosystem services | 148 | Participants | |
| Satisfaction With Dementia Care | Navigated Care | Satisfied with Care Ecosystem services | 107 | Participants | |
| Satisfaction With Dementia Care | Navigated Care | Neutral toward Care Ecosystem services | 57 | Participants | |
| Satisfaction With Dementia Care | Navigated Care | Unsatisfied with Care Ecosystem services | 9 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Navigated Care | 1,024 | |
| Overall Study | STARTED | Survey of Care | 536 | |
| Overall Study | COMPLETED | Navigated Care | 970 | |
| Overall Study | COMPLETED | Survey of Care | 526 | |
| Overall Study | NOT COMPLETED | Navigated Care | 54 | |
| Overall Study | NOT COMPLETED | Survey of Care | 10 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Overnight hospitalization | General disorders | Navigated Care | 218 | 1,024 | 433 |
| serious | Overnight hospitalization | General disorders | Survey of Care | 116 | 536 | 194 |
| serious | Severe fall | General disorders | Navigated Care | 51 | 1,024 | 57 |
| serious | Severe fall | General disorders | Survey of Care | 32 | 536 | 34 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Navigated Care | 74 | 1,024 |
| Total, all-cause mortality | Survey of Care | 39 | 536 |
| Total, other adverse events | Navigated Care | 0 | 1,024 |
| Total, other adverse events | Survey of Care | 0 | 536 |
| Total, serious adverse events | Navigated Care | 269 | 1,024 |
| Total, serious adverse events | Survey of Care | 143 | 536 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG056715 | The Care Ecosystem: Navigating patients and caregivers through stages of dementia care | POSSIN, KATHERINE LAUREL | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE ON AGING | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Navigated Care vs Survey of Care: deaths from any cause | Trial comparisons |
| Navigated Care vs Survey of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02213458
GET https://conductscience.org/api/trials/v1/NCT02213458/registered