Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices

Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services Among Latinos Attending Primary Care Practices

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04418232

Enrollment

243

Registered

2020-06-05

Start date

2022-05-01

Completion date

2024-08-20

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Brief summary

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.

Detailed description

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.

Interventions

COMBINATION_PRODUCTAlianza 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

for care recipients within the dyad: * Identify as Latino * Community dwelling * Diagnosed with mild cognitive impairment or dementia * Have a caregiver 18 years old or older * Have co-participant with access to a privately-owned cell phone with a flat fee for text messages Inclusion Criteria for primary care providers: * Be 18 years old or older * Work as a primary care provider in the US

Exclusion criteria

for care recipients within the dyad: * Not identify as Latino * Not community dwelling * Not diagnosed with mild cognitive impairment or dementia * Not having a caregiver 18 years old or older * Not having a co-participant with access to a privately-owned cell phone with a flat fee for text messages

Design outcomes

Primary

Measure	Time frame	Description
Provider Recruitment Feasibility	During the 9 months of the provider intervention period	Metrics of the number of providers who agree to be trained per month
Provider Retention Feasibility	During the 9 months of the provider intervention period	Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period
Provider Fidelity Feasibility 1	9 months (end of the provider intervention period)	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"
Provider Assessment Feasibility 1	During the 9 months of the provider intervention period	Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills
Provider Fidelity Feasibility 2	During the 9 months of the provider intervention period	Metrics of the Number of referrals to Health Navigator per month
Overall Provider Satisfaction With Training	9 months (end of the provider intervention period)	Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much)
Importance of Navigators to Providers	9 months (end of the provider intervention period)	Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much)
Participant Recruitment Fidelity	During the 15 months of the whole intervention period	Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services
Participant Retention Fidelity	During the 6 months of the Navigator intervention period	Metrics of percentage of referred Latino dementia dyads followed up at six months
Participant Assessment Fidelity	During the 6 months of the Navigator intervention period	Metrics of the percentage of planned baseline and follow-up survey ratings completed
Participant Treatment Adherence	During the 6 months of the Navigator intervention period	Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits
Overall Participant Satisfaction With the Clinic Side of the Intervention	6 months after baseline	Survey question including a 5-item Likert scale on caregivers' satisfaction with clinic services (not at all to very much)
Overall Participant Satisfaction With the Navigator Side of the Intervention	6 months after baseline	Survey question to the caregiver including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much)
Participant Suggestions of Improvement	6 months after baseline	Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change
Practitioner Adherence to Guideline Recommendations	6 months after baseline	10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines

Secondary

Measure	Time frame	Description
Patients' Behavioral Symptoms	Baseline and 6 months from baseline	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.
Patients' Depression	Baseline and 6 months from baseline	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.
Patients' Quality of Life	Baseline and 6 months from baseline	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.
Caregivers' Quality of Life	Baseline and 6 months from baseline	In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied)
Caregivers' Depression	Baseline and 6 months from baseline	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"
Caregivers' Burden	Baseline and 6 months from baseline	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJaime Perales Puchalt, PhD, MPH

KUMC

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	243
Total	243

Baseline characteristics

Characteristic	Alianza Latina
Age, Categorical Caregivers <=18 years	0 Participants
Age, Categorical Caregivers >=65 years	10 Participants
Age, Categorical Caregivers Between 18 and 65 years	90 Participants
Age, Categorical Care recipients <=18 years	0 Participants
Age, Categorical Care recipients >=65 years	76 Participants
Age, Categorical Care recipients Between 18 and 65 years	8 Participants
Age, Categorical Primary care providers <=18 years	0 Participants
Age, Categorical Primary care providers >=65 years	12 Participants
Age, Categorical Primary care providers Between 18 and 65 years	47 Participants
Age, Continuous Caregivers	52.0 years STANDARD_DEVIATION 10.2
Age, Continuous Care recipients	78.2 years STANDARD_DEVIATION 10.2
Age, Continuous Primary care providers	49.5 years STANDARD_DEVIATION 12.8
Caregivers' relation to care recipients Children	73 Participants
Caregivers' relation to care recipients Children-in-law	4 Participants
Caregivers' relation to care recipients Other	12 Participants
Caregivers' relation to care recipients Partner	11 Participants
Dementia diagnosis Alzheimer's dementia	38 Participants
Dementia diagnosis Frontotemporal dementia	2 Participants
Dementia diagnosis Lewy Bodies/Parkinson's dementia	5 Participants
Dementia diagnosis Mild Cognitive Impairment	1 Participants
Dementia diagnosis Mixed dementia	4 Participants
Dementia diagnosis Other	2 Participants
Dementia diagnosis Unspecified dementia	27 Participants
Dementia diagnosis Vascular dementia	5 Participants
Ethnicity (NIH/OMB) Caregivers Hispanic or Latino	95 Participants
Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported	1 Participants
Ethnicity (NIH/OMB) Care recipients Hispanic or Latino	84 Participants
Ethnicity (NIH/OMB) Care recipients Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Care recipients Unknown or Not Reported	0 Participants
Ethnicity (NIH/OMB) Primary care providers Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Primary care providers Not Hispanic or Latino	50 Participants
Ethnicity (NIH/OMB) Primary care providers Unknown or Not Reported	6 Participants
Race (NIH/OMB) Caregivers American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Caregivers Asian	0 Participants
Race (NIH/OMB) Caregivers Black or African American	1 Participants
Race (NIH/OMB) Caregivers More than one race	2 Participants
Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Caregivers Unknown or Not Reported	72 Participants
Race (NIH/OMB) Caregivers White	25 Participants
Race (NIH/OMB) Care recipients American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Care recipients Asian	0 Participants
Race (NIH/OMB) Care recipients Black or African American	1 Participants
Race (NIH/OMB) Care recipients More than one race	0 Participants
Race (NIH/OMB) Care recipients Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Care recipients Unknown or Not Reported	68 Participants
Race (NIH/OMB) Care recipients White	15 Participants
Race (NIH/OMB) Primary care providers American Indian or Alaska Native	4 Participants
Race (NIH/OMB) Primary care providers Asian	0 Participants
Race (NIH/OMB) Primary care providers Black or African American	2 Participants
Race (NIH/OMB) Primary care providers More than one race	4 Participants
Race (NIH/OMB) Primary care providers Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Primary care providers Unknown or Not Reported	3 Participants
Race (NIH/OMB) Primary care providers White	46 Participants
Region of Enrollment United States	243 participants
Sex: Female, Male Caregivers Female	82 Participants
Sex: Female, Male Caregivers Male	18 Participants
Sex: Female, Male Care recipients Female	71 Participants
Sex: Female, Male Care recipients Male	13 Participants
Sex: Female, Male Primary care providers Female	42 Participants
Sex: Female, Male Primary care providers Male	17 Participants
Years of education Caregivers	12.4 years STANDARD_DEVIATION 4.4
Years of education Care recipients	11.2 years STANDARD_DEVIATION 20.4

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	6 / 243
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

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)

Time frame: 9 months (end of the provider intervention period)

Population: Primary care providers that are part of Aim 2a (Only among the people who reported using health navigators)

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Importance of Navigators to Providers	Not at all	0 Participants
Alianza Latina	Importance of Navigators to Providers	Slightly	0 Participants
Alianza Latina	Importance of Navigators to Providers	Moderately	0 Participants
Alianza Latina	Importance of Navigators to Providers	Very much	0 Participants
Alianza Latina	Importance of Navigators to Providers	Extremely	1 Participants

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)

Time frame: 6 months after baseline

Population: Participants responding to these are caregivers

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Overall Participant Satisfaction With the Clinic Side of the Intervention	Not at all	7 Participants
Alianza Latina	Overall Participant Satisfaction With the Clinic Side of the Intervention	Somehow	13 Participants
Alianza Latina	Overall Participant Satisfaction With the Clinic Side of the Intervention	Very	52 Participants
Alianza Latina	Overall Participant Satisfaction With the Clinic Side of the Intervention	Extremely	15 Participants
Alianza Latina	Overall Participant Satisfaction With the Clinic Side of the Intervention	Missing	12 Participants
Alianza Latina	Overall Participant Satisfaction With the Clinic Side of the Intervention	Does not know	1 Participants

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)

Time frame: 6 months after baseline

Population: Participants responding to these are caregivers

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Overall Participant Satisfaction With the Navigator Side of the Intervention	Not at all	0 Participants
Alianza Latina	Overall Participant Satisfaction With the Navigator Side of the Intervention	Somehow	5 Participants
Alianza Latina	Overall Participant Satisfaction With the Navigator Side of the Intervention	Very	43 Participants
Alianza Latina	Overall Participant Satisfaction With the Navigator Side of the Intervention	Extremely	40 Participants
Alianza Latina	Overall Participant Satisfaction With the Navigator Side of the Intervention	Missing	12 Participants

Primary

Overall Provider Satisfaction With Training

Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much)

Time frame: 9 months (end of the provider intervention period)

Population: Primary care providers that are part of Aim 2a

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Overall Provider Satisfaction With Training	Not at all	0 Participants
Alianza Latina	Overall Provider Satisfaction With Training	Slightly	2 Participants
Alianza Latina	Overall Provider Satisfaction With Training	Moderately	4 Participants
Alianza Latina	Overall Provider Satisfaction With Training	very much	15 Participants
Alianza Latina	Overall Provider Satisfaction With Training	Extremely	21 Participants
Alianza Latina	Overall Provider Satisfaction With Training	Missing	17 Participants

Primary

Participant Assessment Fidelity

Metrics of the percentage of planned baseline and follow-up survey ratings completed

Time frame: During the 6 months of the Navigator intervention period

Population: Participants responding to these are dyads (caregivers and, when possible, care recipients)

Arm	Measure	Value (NUMBER)
Alianza Latina	Participant Assessment Fidelity	77 Percent of dyads

Primary

Participant Recruitment Fidelity

Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services

Time frame: During the 15 months of the whole intervention period

Population: 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)

Arm	Measure	Value (NUMBER)
Alianza Latina	Participant Recruitment Fidelity	78.7 Percentage of dyads

Primary

Participant Retention Fidelity

Metrics of percentage of referred Latino dementia dyads followed up at six months

Time frame: During the 6 months of the Navigator intervention period

Population: 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)

Arm	Measure	Value (NUMBER)
Alianza Latina	Participant Retention Fidelity	69.3 Percentage of dyads

Primary

Participant Suggestions of Improvement

Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change

Time frame: 6 months after baseline

Population: Participants responding to these are caregivers

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Participant Suggestions of Improvement	Responded	88 Participants
Alianza Latina	Participant Suggestions of Improvement	Missing	12 Participants

Primary

Participant Treatment Adherence

Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits

Time frame: During the 6 months of the Navigator intervention period

Population: Participants responding to these are dyads (caregivers and, when possible, care recipients)

Arm	Measure	Value (NUMBER)
Alianza Latina	Participant Treatment Adherence	29 Percentage of dyads

Primary

Practitioner Adherence to Guideline Recommendations

10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines

Time frame: 6 months after baseline

Population: 87 respondents

Arm	Measure	Value (MEDIAN)
Alianza Latina	Practitioner Adherence to Guideline Recommendations	9 Guideline Items in the checklist covered

Primary

Provider Assessment Feasibility 1

Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills

Time frame: During the 9 months of the provider intervention period

Population: Primary care providers that are part of Aim 2a

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Provider Assessment Feasibility 1	43 Participants

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

Time frame: 9 months (end of the provider intervention period)

Population: Primary care providers that are part of Aim 2a

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Provider Fidelity Feasibility 1	not at all	1 Participants
Alianza Latina	Provider Fidelity Feasibility 1	to some degree	5 Participants
Alianza Latina	Provider Fidelity Feasibility 1	usually	19 Participants
Alianza Latina	Provider Fidelity Feasibility 1	almost always	9 Participants
Alianza Latina	Provider Fidelity Feasibility 1	always	8 Participants
Alianza Latina	Provider Fidelity Feasibility 1	Missing	17 Participants

Primary

Provider Fidelity Feasibility 2

Metrics of the Number of referrals to Health Navigator per month

Time frame: During the 9 months of the provider intervention period

Population: Primary care providers that are part of Aim 2a

Arm	Measure	Value (MEAN)	Dispersion
Alianza Latina	Provider Fidelity Feasibility 2	5.77 Referrals per month	Standard Deviation 3.45

Primary

Provider Recruitment Feasibility

Metrics of the number of providers who agree to be trained per month

Time frame: During the 9 months of the provider intervention period

Arm	Measure	Value (MEAN)	Dispersion
Alianza Latina	Provider Recruitment Feasibility	1.44 Providers trained per month	Standard Deviation 2.74

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

Time frame: During the 9 months of the provider intervention period

Population: Primary care providers that are part of Aim 2a

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Alianza Latina	Provider Retention Feasibility	11 Participants

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.