Alzheimer Disease, Dementia, Dementia, Vascular, Frontotemporal Lobar Degeneration, Lewy Body Disease, Memory Disorders
Conditions
Keywords
Pragmatic Clinical Trial, Family Caregivers, Patient Care Management
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.
Interventions
BEHAVIORALNavigated 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).
Sponsors
University of Nebraska
Centers for Medicare and Medicaid Services
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will enroll patients as well as their primary caregivers as research participants. Inclusion criteria for patient participants: 1. Patient has a diagnosis of dementia with a progressive course 2. Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study 3. Patient is covered by Medicare or Medi-caid or is Medi-pending 4. 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 5. Patient speaks either English, Cantonese, Mandarin, or Spanish 6. Patient lives in California or Nebraska or Iowa 7. Patient is age 45 or older Inclusion criteria for caregiver participants: 1. Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study 2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish 3. Caregiver is a legal adult
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1,024 |
| Survey of Care Control group that will undergo the same regular assessments as patients enrolled in Navigated Care | 536 |
| Total | 1,560 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | No longer meets criteria: caregiver deceased | 4 | 0 |
| Overall Study | No longer meets criteria: caregiver no longer caregiving | 4 | 0 |
| Overall Study | No longer meets criteria: caregiver too sick to participate | 2 | 0 |
| Overall Study | No longer meets criteria: patient moved out of state | 10 | 0 |
| Overall Study | Refused re-consent | 6 | 0 |
| Overall Study | Withdrawal by Subject | 26 | 8 |
Baseline characteristics
| Characteristic | Navigated Care | Survey of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 783 Participants | 379 Participants | 1162 Participants |
| Age, Categorical Between 18 and 65 years | 241 Participants | 157 Participants | 398 Participants |
| Age, Continuous | 78.1 years STANDARD_DEVIATION 8.66 | 78.1 years STANDARD_DEVIATION 12 | 78.1 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 107 Participants | 58 Participants | 165 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 911 Participants | 477 Participants | 1388 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 73 Participants | 29 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 19 Participants | 64 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 72 Participants | 37 Participants | 109 Participants |
| Race (NIH/OMB) White | 825 Participants | 447 Participants | 1272 Participants |
| Region of Enrollment United States | 1024 participants | 536 participants | 1560 participants |
| Sex/Gender, Customized Female | 656 Participants | 336 Participants | 992 Participants |
| Sex/Gender, Customized Male | 226 Participants | 200 Participants | 426 Participants |
| Sex/Gender, Customized Other | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 74 / 1,024 | 39 / 536 |
| other Total, other adverse events | 0 / 1,024 | 0 / 536 |
| serious Total, serious adverse events | 269 / 1,024 | 143 / 536 |
Outcome results
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
Time frame: Baseline to one year
Population: The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigated Care | Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year | -1.43 units on a scale | Standard Deviation 5.64 |
| Survey of Care | Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year | -1.12 units on a scale | Standard Deviation 5.87 |
Comparison: Linear mixed effects modelp-value: 0.0495% CI: [0.259, 1.337]Mixed Models Analysis
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.
Time frame: Baseline to one year
Population: Subset of patients with complete data on QDRS and Zarit burden at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigated Care | Change in Caregiver Burden, Baseline to One Year | -1.682 score on a scale | Standard Deviation 8.144 |
| Survey of Care | Change in Caregiver Burden, Baseline to One Year | -1.482 score on a scale | Standard Deviation 8.641 |
p-value: 0.0795% CI: [-3.885, -0.08]Mixed Models Analysis
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.
Time frame: Baseline to one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigated Care | Change in Caregiver Depression, Baseline to One Year | -0.831 score on a scale | Standard Deviation 4.312 |
| Survey of Care | Change in Caregiver Depression, Baseline to One Year | -0.238 score on a scale | Standard Deviation 4.053 |
p-value: 0.0395% CI: [-2.154, -0.132]Mixed Models Analysis
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.
Time frame: Baseline to one year
Population: Subset of patients with complete data on QDRS and emergency department visits at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigated Care | Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year | .0483 number of encounters | Standard Deviation 0.703 |
| Survey of Care | Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year | .175 number of encounters | Standard Deviation 0.84 |
p-value: 0.0595% CI: [-0.295, -0.02]Mixed Models Analysis
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.
Time frame: Baseline to one year
Population: Dyads with baseline data on dementia severity (QDRS) and self-efficacy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigated Care | Change in Caregiver Self-efficacy, Baseline to One Year | 1.356 units on a scale | Standard Deviation 3.038 |
| Survey of Care | Change in Caregiver Self-efficacy, Baseline to One Year | 1.043 units on a scale | Standard Deviation 2.647 |
p-value: 0.1195% CI: [-0.135, 1.405]Mixed Models Analysis
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.
Time frame: One year
Population: Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navigated Care | Satisfaction With Dementia Care | Very satisfied with Care Ecosystem services | 148 Participants |
| Navigated Care | Satisfaction With Dementia Care | Satisfied with Care Ecosystem services | 107 Participants |
| Navigated Care | Satisfaction With Dementia Care | Neutral toward Care Ecosystem services | 57 Participants |
| Navigated Care | Satisfaction With Dementia Care | Unsatisfied with Care Ecosystem services | 9 Participants |
| Navigated Care | Satisfaction With Dementia Care | Very unsatisfied with Care Ecosystem services | 4 Participants |