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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG056715 | U.S. NIH Grant/Contract | View source | |
| 1C1CMS331346 | Other Grant/Funding Number | Centers for Medicare and Medicaid Services |
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| Name | Class |
|---|---|
| University of Nebraska | OTHER |
| Centers for Medicare and Medicaid Services | FED |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigated Care | Experimental | Comprehensive longitudinal continuing care program |
|
| Survey of Care | No Intervention | Control group that will undergo the same regular assessments as patients enrolled in Navigated Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigated Care | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life-Alzheimer's Disease, Change From Baseline to 1 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 | Baseline to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Reported Rate of Emergency Department Utilization: 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. | Baseline to one year |
| Change in Caregiver Burden, Baseline to One Year |
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This study will enroll patients as well as their primary caregivers as research participants.
Inclusion criteria for patient participants:
Inclusion criteria for caregiver participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine L Possin, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| University of Nebraska Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37721734 | Result | Guterman EL, Kiekhofer RE, Wood AJ, Allen IE, Kahn JG, Dulaney S, Merrilees JJ, Lee K, Chiong W, Bonasera SJ, Braley TL, Hunt LJ, Harrison KL, Miller BL, Possin KL. Care Ecosystem Collaborative Model and Health Care Costs in Medicare Beneficiaries With Dementia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1222-1228. doi: 10.1001/jamainternmed.2023.4764. | |
| 36331050 | Result | Liu AK, Possin KL, Cook KM, Lynch S, Dulaney S, Merrilees JJ, Braley T, Kiekhofer RE, Bonasera SJ, Allen IE, Chiong W, Clark AM, Feuer J, Ewalt J, Guterman EL, Gearhart R, Miller BL, Lee KP. Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Alzheimers Dement. 2023 May;19(5):1865-1875. doi: 10.1002/alz.12808. Epub 2022 Nov 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Navigated Care | Comprehensive longitudinal continuing care program 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). |
| FG001 | Survey of Care | Control group that will undergo the same regular assessments as patients enrolled in Navigated Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Navigated Care | Comprehensive longitudinal continuing care program 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life-Alzheimer's Disease, Change From Baseline to 1 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 | The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months | Posted | Mean | Standard Deviation | units on a scale | Baseline to one year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Navigated Care | Comprehensive longitudinal continuing care program 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overnight hospitalization | General disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Possin | University of California, San Francisco | (415) 476-1889 | katherine.possin@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2018 | Feb 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2018 | Feb 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D015140 | Dementia, Vascular |
| D020961 | Lewy Body Disease |
| D057174 | Frontotemporal Lobar Degeneration |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
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. |
| Baseline to one year |
| Satisfaction With Dementia Care | 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. | One year |
| Change in Caregiver Depression, Baseline to One Year | Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27. | Baseline to one year |
| Change in Caregiver Self-efficacy, 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. | Baseline to one year |
| Omaha |
| Nebraska |
| 68198 |
| United States |
| 31566651 | Result | Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101. |
| No longer meets criteria: caregiver too sick to participate |
|
| No longer meets criteria: patient moved out of state |
|
| Refused re-consent |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | Survey of Care | Control group that will undergo the same regular assessments as patients enrolled in Navigated Care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Survey of Care | Control group that will undergo the same regular assessments as patients enrolled in Navigated Care |
|
|
|
| Secondary | Change in Caregiver Reported Rate of Emergency Department Utilization: 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. | Subset of patients with complete data on QDRS and emergency department visits at baseline | Posted | Mean | Standard Deviation | number of encounters | Baseline to one year |
|
|
|
|
| Secondary | Change in Caregiver Burden, 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. | Subset of patients with complete data on QDRS and Zarit burden at baseline | Posted | Mean | Standard Deviation | score on a scale | Baseline to one year |
|
|
|
|
| Secondary | Satisfaction With Dementia Care | 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. | Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months | Posted | Count of Participants | Participants | One year |
|
|
|
| Secondary | Change in Caregiver Depression, Baseline to One Year | Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27. | Posted | Mean | Standard Deviation | score on a scale | Baseline to one year |
|
|
|
|
| Secondary | Change in Caregiver Self-efficacy, 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. | Dyads with baseline data on dementia severity (QDRS) and self-efficacy | Posted | Mean | Standard Deviation | units on a scale | Baseline to one year |
|
|
|
|
| 74 |
| 1,024 |
| 269 |
| 1,024 |
| 0 |
| 1,024 |
| EG001 | Survey of Care | Control group that will undergo the same regular assessments as patients enrolled in Navigated Care | 39 | 536 | 143 | 536 | 0 | 536 |
| Severe fall | General disorders | Systematic Assessment | Falls resulting in major injury (broken bone, major bleeding, or loss of consciousness) |
|
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unsatisfied with Care Ecosystem services |
|
| Very unsatisfied with Care Ecosystem services |
|