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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The research team will train primary care practitioners from Kansas City clinics to enhance skills in cultural competence, dementia detection, treatment and referral to a Health Navigator among Latinos 65 and older with dementia. The Health Navigator will provide patient/caregiver dyads referred by Alianza Latina providers with care management, psychosocial support and links to relevant community resources. Outcomes include feasibility and acceptability of 1) PCP training and 2) patient and caregiver dementia care.
Alzheimer's disease and related dementias (ADRD) are a major cause of mortality and disability in later life and cost the US healthcare system more than cancer or heart disease. The National Alzheimer's Plan Act and the National Institutes of Health have identified ADRD disparities among ethnic minorities as a public health priority. Latinos with ADRD experience substantial disparities with reduced rates of early diagnosis and lower quality care compared to their non-Latino white peers, which put them at an increased risk for steeper cognitive decline, morbidity, mortality and higher caregiver burden. A number of barriers conspire to create these disparities including a lack of an evidence-based strategy to address ADRD in clinics, patient and primary care provider (PCP) reduced ADRD knowledge, negative attitudes regarding ADRD, PCP's lack of time, cultural and language barriers and health insurance status. To improve healthcare delivery to Latinos with ADRD, researchers need to redesign current ADRD detection and care systems to follow evidence-based recommendations for early detection and culturally appropriate chronic care.
The overall aim of this proposal is to enhance the delivery of ADRD services to Latinos in primary care through a scalable systems approach that includes evidence-based recommendations. Primary care clinics are the ideal setting to provide ADRD services, as 93% of older Latinos have a usual source of healthcare. The novel systems approach (Alianza Latina/Latino Alliance) will enhance timely ADRD diagnosis and optimal care to minimize behavioral symptoms and cognitive decline among Latinos in a linguistically and culturally-appropriate way. Alianza Latina will use the Collaborative Care Framework that capitalizes on PCPs and Health Navigators. 1) PCPs will undergo evidence-based training to enhance timely and culturally appropriate diagnosis and implement it in their work routine. 2) PCPs will detect, treat and refer Latino ADRD patients to a bilingual Health Navigator to provide chronic care management, which will reduce PCP time burden.
Aim 2: Test the feasibility and acceptability of Alianza Latina. Aim 2.a: The research team will train PCPs from Kansas City clinics to enhance skills in cultural competence, ADRD detection, treatment and referral to a Health Navigator among Latinos 65 and older with ADRD. Aim 2.b. The Health Navigator will provide patients/caregiver dyads referred by Alianza Latina PCPs with care management, psychosocial support and links to relevant community resources. The research team will assess the feasibility and acceptability of 1) PCP training and 2) patient and caregiver ADRD care. Caregivers will be enrolled in a text messaging program, called CuidaTEXT, that will educate about memory and thinking problems, solve problems that are common among families with memory and thinking problems, send reminders for appointments and medications, and improve communication with the PCP, family, friends, and other resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alianza Latina | Experimental | The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alianza Latina | Combination Product | The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators. |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Recruitment Feasibility | Metrics of the number of providers who agree to be trained per month | During the 9 months of the provider intervention period |
| Provider Retention Feasibility | Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period | During the 9 months of the provider intervention period |
| Provider Fidelity Feasibility 1 | Percentage of providers able to implement screenings in regular workflow, measured via survey with the question "To what extent were you able to implement screenings in regular workflow" with three response options: "not at all", "to some degree", "usually", "almost always" and "always" | 9 months (end of the provider intervention period) |
| Provider Assessment Feasibility 1 | Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills | During the 9 months of the provider intervention period |
| Provider Fidelity Feasibility 2 | Metrics of the Number of referrals to Health Navigator per month | During the 9 months of the provider intervention period |
| Overall Provider Satisfaction With Training | Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much) | 9 months (end of the provider intervention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Behavioral Symptoms | Brief version of the Neuropsychiatry Inventory Questionnaire: This is a validated clinical instrument for evaluating psychopathology in dementia. If any of the 12 neuropsychiatric symptoms is present, caregivers rate their loved one's severity on a three-point scale (mild-severe). For example, if the caregiver responds yes to "is the patient resistive to help from others at times, or hard to handle?", the following question would follow: "rate the severity of the symptom". An overall severity summary score is calculated by adding the severity scores of all items, ranging from 0 to 36, and higher scores mean higher severity. |
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Inclusion Criteria for care recipients within the dyad:
Inclusion Criteria for primary care providers:
Exclusion Criteria for care recipients within the dyad:
Exclusion Criteria for primary care providers:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Perales Puchalt, PhD, MPH | KUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
The final dataset will include patients' and caregivers' demographic and behavioral data from interviews as well as metrics and feasibility information provided by the primary care providers. Along with the dataset, we will create a code book documenting all variables. Study participants may find their diagnosis information potentially stigmatizing, and may prefer that these diagnoses remain entirely confidential. Although the data analytic files will not have direct identifiers (only study identification numbers), the possibility of deductive disclosure of subjects with certain clinical characteristics may remain. To safeguard against the unlikely event of deductive disclosure, we will only make the data files and codebook available to other researchers on a case-by-case basis.
February 1, 2025
Researchers requesting data will need to complete a request form outlining intended use of the data, and agree to use the data solely for this intended purpose. Prior to data release, researchers requesting data will be required to sign a confidentiality agreement specifying that they will not identify any individual participant, that they will use secure technology to safeguard the data, and that they will destroy or return the data after their analyses are completed.
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This study includes 100 dyads. Each dyad is formed by a unique caregiver and a care recipient. Ten care recipients are in more than one dyad, as more than one of their caregivers participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alianza Latina | The main components of Alianza Latina were:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analyses include the 59 primary care providers from aim 2a, and the 100 caregivers and 84 care recipients that form the 100 dyads from Aim 2b. Each dyad is formed by a unique caregiver and a care recipient. Ten care recipients are in more than one dyad, as more than one of their caregivers participated in the study. For clarity of results, baseline variables refer to care recipients unless the variable name states that it refers to a different sample (caregiver or primary care provider).
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| ID | Title | Description |
|---|---|---|
| BG000 | Alianza Latina | The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers). |
| 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 | Provider Recruitment Feasibility | Metrics of the number of providers who agree to be trained per month | Posted | Mean | Standard Deviation | Providers trained per month | During the 9 months of the provider intervention period |
|
|
6 months
Adverse Events were not monitored in any participant population due to this project being minimal risk. instead, the research team monitored unanticipated problems.
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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 | Alianza Latina | The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators. This number includes 100 caregivers of 84 care recipients who underwent the Alianza Latina care support intervention; 26 caregivers were part of 10 clusters of 2 (n=5), 3 (n=4), and 4 (n=1) caregivers of the same person with dementia. This number also includes results from 59 primary care providers who underwent a dementia training delivered as standard training by the KU Alzheimer's Disease Research Center. Data for all 3 groups are provided together because they are part of the same intervention, and not interventions that were compared. Mortality only happened among care recipients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime Perales Puchalt | University of Kansas Medical Center | 913-588-3716 | jperales@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2022 | Dec 2, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2022 | Dec 2, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| Importance of Navigators to Providers |
Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much) |
| 9 months (end of the provider intervention period) |
| Participant Recruitment Fidelity | Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services | During the 15 months of the whole intervention period |
| Participant Retention Fidelity | Metrics of percentage of referred Latino dementia dyads followed up at six months | During the 6 months of the Navigator intervention period |
| Participant Assessment Fidelity | Metrics of the percentage of planned baseline and follow-up survey ratings completed | During the 6 months of the Navigator intervention period |
| Participant Treatment Adherence | Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits | During the 6 months of the Navigator intervention period |
| Overall Participant Satisfaction With the Clinic Side of the Intervention | Survey question including a 5-item Likert scale on caregivers' satisfaction with clinic services (not at all to very much) | 6 months after baseline |
| Overall Participant Satisfaction With the Navigator Side of the Intervention | Survey question to the caregiver including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much) | 6 months after baseline |
| Participant Suggestions of Improvement | Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change | 6 months after baseline |
| Practitioner Adherence to Guideline Recommendations | 10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines | 6 months after baseline |
| Baseline and 6 months from baseline |
| Patients' Depression | Short Geriatric Depression Scale: This scale measures depressive symptomatology, and consists of 15 yes vs no questions. Of the 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. A summary score is obtained ranging from 0 to 15, with higher scores meaning more severe depressive symptomatology. | Baseline and 6 months from baseline |
| Patients' Quality of Life | Quality of Life in Alzheimer's Disease: The Quality of Life in Alzheimer's Disease is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better quality of life. | Baseline and 6 months from baseline |
| Caregivers' Quality of Life | In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied) | Baseline and 6 months from baseline |
| Caregivers' Depression | 10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don't bother me" | Baseline and 6 months from baseline |
| Caregivers' Burden | Short Zarit Burden Interview: This caregiver burden scale has 6 items that address the perceived impact of the act of providing care on the physical health, emotional health, social activities and financial situation of the caregiver. Each item has five response options ranging from "never" to "nearly always". A total score is obtained by adding scores in all items, with a range from 0 to 24. Higher scores mean higher burden. | Baseline and 6 months from baseline |
| Count of Participants |
| Participants |
|
| Age, Continuous | Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers). | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Caregivers' relation to care recipients | Number analyzed in row differs from overall because it only refers to caregivers' relation to care recipients. | Count of Participants | Participants |
|
| Dementia diagnosis | Number analyzed in row differs from overall, because analyses only refer to care recipients. | Count of Participants | Participants |
|
| Years of education | Number analyzed in row differs from overall because we are reporting different samples (care recipients and caregivers). | Mean | Standard Deviation | years |
|
|
| Primary | Provider Retention Feasibility | Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period | Primary care providers that are part of Aim 2a | Posted | Count of Participants | Participants | During the 9 months of the provider intervention period |
|
|
|
| Primary | Provider Fidelity Feasibility 1 | Percentage of providers able to implement screenings in regular workflow, measured via survey with the question "To what extent were you able to implement screenings in regular workflow" with three response options: "not at all", "to some degree", "usually", "almost always" and "always" | Primary care providers that are part of Aim 2a | Posted | Count of Participants | Participants | 9 months (end of the provider intervention period) |
|
|
|
| Primary | Provider Assessment Feasibility 1 | Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills | Primary care providers that are part of Aim 2a | Posted | Count of Participants | Participants | During the 9 months of the provider intervention period |
|
|
|
| Primary | Provider Fidelity Feasibility 2 | Metrics of the Number of referrals to Health Navigator per month | Primary care providers that are part of Aim 2a | Posted | Mean | Standard Deviation | Referrals per month | During the 9 months of the provider intervention period |
|
|
|
| Primary | Overall Provider Satisfaction With Training | Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much) | Primary care providers that are part of Aim 2a | Posted | Count of Participants | Participants | 9 months (end of the provider intervention period) |
|
|
|
| Primary | Importance of Navigators to Providers | Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much) | Primary care providers that are part of Aim 2a (Only among the people who reported using health navigators) | Posted | Count of Participants | Participants | 9 months (end of the provider intervention period) |
|
|
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| Primary | Participant Recruitment Fidelity | Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services | The Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow because this variable reports the dyads who end up enrolling (100) out of the ones referred (127) | Posted | Number | Percentage of dyads | During the 15 months of the whole intervention period |
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|
|
| Primary | Participant Retention Fidelity | Metrics of percentage of referred Latino dementia dyads followed up at six months | The Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow because this variable reports the dyads who are followed up (88) out of the ones referred (127) | Posted | Number | Percentage of dyads | During the 6 months of the Navigator intervention period |
|
|
|
| Primary | Participant Assessment Fidelity | Metrics of the percentage of planned baseline and follow-up survey ratings completed | Participants responding to these are dyads (caregivers and, when possible, care recipients) | Posted | Number | Percent of dyads | During the 6 months of the Navigator intervention period |
|
|
|
| Primary | Participant Treatment Adherence | Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits | Participants responding to these are dyads (caregivers and, when possible, care recipients) | Posted | Number | Percentage of dyads | During the 6 months of the Navigator intervention period |
|
|
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| Primary | Overall Participant Satisfaction With the Clinic Side of the Intervention | Survey question including a 5-item Likert scale on caregivers' satisfaction with clinic services (not at all to very much) | Participants responding to these are caregivers | Posted | Count of Participants | Participants | 6 months after baseline |
|
|
|
| Primary | Overall Participant Satisfaction With the Navigator Side of the Intervention | Survey question to the caregiver including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much) | Participants responding to these are caregivers | Posted | Count of Participants | Participants | 6 months after baseline |
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|
|
| Primary | Participant Suggestions of Improvement | Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change | Participants responding to these are caregivers | Posted | Count of Participants | Participants | 6 months after baseline |
|
|
|
| Primary | Practitioner Adherence to Guideline Recommendations | 10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines | 87 respondents | Posted | Median | Inter-Quartile Range | Guideline Items in the checklist covered | 6 months after baseline |
|
|
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| Secondary | Patients' Behavioral Symptoms | Brief version of the Neuropsychiatry Inventory Questionnaire: This is a validated clinical instrument for evaluating psychopathology in dementia. If any of the 12 neuropsychiatric symptoms is present, caregivers rate their loved one's severity on a three-point scale (mild-severe). For example, if the caregiver responds yes to "is the patient resistive to help from others at times, or hard to handle?", the following question would follow: "rate the severity of the symptom". An overall severity summary score is calculated by adding the severity scores of all items, ranging from 0 to 36, and higher scores mean higher severity. | Participants responding to these are caregivers on behalf of care recipients | Posted | Mean | Standard Deviation | Change in units on a scale | Baseline and 6 months from baseline |
|
|
|
| Secondary | Patients' Depression | Short Geriatric Depression Scale: This scale measures depressive symptomatology, and consists of 15 yes vs no questions. Of the 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. A summary score is obtained ranging from 0 to 15, with higher scores meaning more severe depressive symptomatology. | Participants responding to these are caregivers on behalf of care recipients or care recipients themselves when possible | Posted | Mean | Standard Deviation | Change in units on a scale | Baseline and 6 months from baseline |
|
|
|
| Secondary | Patients' Quality of Life | Quality of Life in Alzheimer's Disease: The Quality of Life in Alzheimer's Disease is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better quality of life. | Participants responding to these are caregivers on behalf of care recipients or care recipients themselves when possible | Posted | Mean | Standard Deviation | Change in units on a scale | Baseline and 6 months from baseline |
|
|
|
| Secondary | Caregivers' Quality of Life | In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied) | Participants responding to these are caregivers on their behalf | Posted | Mean | Standard Deviation | Change in units on a scale | Baseline and 6 months from baseline |
|
|
|
| Secondary | Caregivers' Depression | 10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don't bother me" | Participants responding to these are caregivers on their behalf | Posted | Mean | Standard Deviation | Change in units on a scale | Baseline and 6 months from baseline |
|
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| Secondary | Caregivers' Burden | Short Zarit Burden Interview: This caregiver burden scale has 6 items that address the perceived impact of the act of providing care on the physical health, emotional health, social activities and financial situation of the caregiver. Each item has five response options ranging from "never" to "nearly always". A total score is obtained by adding scores in all items, with a range from 0 to 24. Higher scores mean higher burden. | Participants responding to these are caregivers on their behalf | Posted | Mean | Standard Deviation | Change in units on a scale | Baseline and 6 months from baseline |
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| 6 |
| 243 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D001523 | Mental Disorders |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| almost always |
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| always |
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| Missing |
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| very much |
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| Extremely |
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| Missing |
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| Very much |
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| Extremely |
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| Extremely |
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| Missing |
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| Does not know |
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| Extremely |
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| Missing |
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