DementiaPhase 1NCT04418232
Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices
A Phase 1 study testing Alianza Latina in people with Dementia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Alianza Latina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Be 18 years old or older
- Work as a primary care provider in the US
Who cannot join
- 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
- Younger than 18 years old
- Not work as a primary care provider in the US
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66103
About this study
Official title: Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Alianza Latina
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alianza LatinaCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Alianza Latina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Recruitment Feasibility
Metrics of the number of providers who agree to be trained per month
Measured: 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
Measured: 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"
Measured: 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
Measured: During the 9 months of the provider intervention period
Provider Fidelity Feasibility 2
Metrics of the Number of referrals to Health Navigator per month
Measured: 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)
Measured: 9 months (end of the provider intervention period)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 6 months after baseline
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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"
Measured: 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.
Measured: Baseline and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 May 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Jaime Perales Puchalt, PhD, MPH, Principal investigator, KUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418232
- Sponsor's protocol ID
- STUDY00145615
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2020
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services Among Latinos Attending Primary Care Practices
- ClinicalTrials.gov ID
- NCT04418232
- Acronym / sponsor ID
- STUDY00145615
- Conditions
- Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alianza Latina | Experimental | Combination Product: Alianza LatinaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alianza LatinaThe 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. | Combination product | Alianza Latina |
Primary outcome
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
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
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"
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
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
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)
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)
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
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
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
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
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)
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)
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
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
6 secondary outcomes
Patients' Behavioral Symptoms
Time frame: Baseline and 6 months from baseline
Patients' Depression
Time frame: Baseline and 6 months from baseline
Patients' Quality of Life
Time frame: Baseline and 6 months from baseline
Caregivers' Quality of Life
Time frame: Baseline and 6 months from baseline
Caregivers' Depression
Time frame: Baseline and 6 months from baseline
Caregivers' Burden
Time frame: Baseline and 6 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Perales Puchalt, PhD, MPH principal investigator
KUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alianza Latina in people with Dementia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Recruitment Feasibility (time frame: During the 9 months of the provider intervention period). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.