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

NCT04418232 | Completed Phase 1 Results

• 1 other identifier: STUDY00145615
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (15)

• 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)

• 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

Secondary Outcomes (6)

• Patients' Behavioral Symptoms

  Baseline and 6 months from baseline

• Patients' Depression

  Baseline and 6 months from baseline

• Patients' Quality of Life

  Baseline and 6 months from baseline

• Caregivers' Quality of Life

  Baseline and 6 months from baseline

• Caregivers' Depression

  Baseline and 6 months from baseline

Study Arms (1)

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.

Combination Product: Alianza Latina

Interventions

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.

Alianza Latina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Jaime Perales Puchalt
• Organization: University of Kansas Medical Center

jperales@kumc.edu

913-588-3716

Study Officials

• Jaime Perales Puchalt, PhD, MPH

  KUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: May 1, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: April 29, 2026
• Results First Posted: December 20, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: February 1, 2025
• Access Criteria: 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.

Locations

US (1)