Skip to main content
OpenTrials
Completed

NCT Number: NCT04418232

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

for primary care providers:

  • Younger than 18 years old
  • Not work as a primary care provider in the US

Treatment and study plan

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.

Primary outcomes

  1. Provider Recruitment Feasibility

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

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

  2. Provider Retention Feasibility

    Time frame: 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

  3. Provider Fidelity Feasibility 1

    Time frame: 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"

  4. Provider Assessment Feasibility 1

    Time frame: 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

  5. Provider Fidelity Feasibility 2

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

    Metrics of the Number of referrals to Health Navigator per month

  6. Overall Provider Satisfaction With Training

    Time frame: 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)

  7. Importance of Navigators to Providers

    Time frame: 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)

  8. Participant Recruitment Fidelity

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

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

  9. Participant Retention Fidelity

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

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

  10. Participant Assessment Fidelity

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

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

  11. Participant Treatment Adherence

    Time frame: 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

  12. Overall Participant Satisfaction With the Clinic Side of the Intervention

    Time frame: 6 months after baseline

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

  13. Overall Participant Satisfaction With the Navigator Side of the Intervention

    Time frame: 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)

  14. Participant Suggestions of Improvement

    Time frame: 6 months after baseline

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

  15. Practitioner Adherence to Guideline Recommendations

    Time frame: 6 months after baseline

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

Secondary outcomes

  1. Patients' Behavioral Symptoms

    Time frame: 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.

  2. Patients' Depression

    Time frame: 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.

  3. Patients' Quality of Life

    Time frame: 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.

  4. Caregivers' Quality of Life

    Time frame: 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)

  5. Caregivers' Depression

    Time frame: 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"

  6. Caregivers' Burden

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.