Testing the Effects of a Text Message Caregiver Support Intervention for Latinos (CuidaTEXT R01)

December 3, 2025 updated by: Jaime Perales Puchalt, PhD, MPH, University of Kansas Medical Center

The goal of this randomized clinical trial it to test the efficacy of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos.

Researchers will compare those who receive the CuidaTEXT intervention to those who do not receive the intervention to see if CuidaTEXT effects Latino caregiver stressors and their negative consequences .

Participants will receive a variety of text messages, from automatic to keyword-drive, regarding ADRD education, social support, self-care, ADRD care management, and behavioral symptoms. Participants will also complete measures regarding depressive symptoms, coping, behavioral symptoms, and preparedness for caregiving.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jaime Perales Puchalt, PhD, MPH
  • Phone Number: 913-588-3716
  • Email: jperales@kumc.edu

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Jaime Perales Puchalt, PhD, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over the age of 18
  • Spanish and English-speaking people who identify as Latino
  • Reports providing hands-on care for a relative who has been given a clinical or research ADRD diagnosis and has an Eight-item Informant Interview to Differentiate Aging and Dementia (AD-8) screening score ≥2, indicating cognitive impairment
  • Has a score of 7 or higher on the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)
  • Self-reports being able to read and write
  • Owns a cell phone with a flat fee, and uses it at least weekly for texting.

Exclusion Criteria:

  • Participation in another wellbeing-related clinical trial
  • Cohabitation with another participant in the CuidaTEXT R01 Study
  • Participants who provide care for a person with ADRD already cared for by another participant in the CuidaTEXT R01 study
  • Participant plans to move to another country within seven months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CuidaTEXT
6 months of CuidaTEXT intervention + 1-month post-treatment
Behavioral: CuidaTEXT
CuidaTEXT is a multidomain, bilingual 6-month text message intervention that includes delivery and content features tailored to Latino caregivers. All caregivers receive one core daily automatic message on five domains: ADRD education, social support, self-care, ADRD care management, and behavioral symptoms. Caregivers can access on-demand automatic messages to expand on the five domains via sending keywords and interact with a coach via a live chat for more personalized help.
No Intervention: 7-Month Waitlist Control
Participants allocated to this arm will be offered the opportunity to start CuidaTEXT immediately after their 7 Month follow-up assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver depressive symptoms
Time Frame: Baseline and 6 months
Change in caregiver depressive symptoms from baseline to 6 months as measured by the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10). The CES-D-10 is a self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness). Each item is rated on a 4-point scale (Rarely or None of the Time-Most or All of the Time). The summary score ranges from 0 to 30 with higher scores indicating higher severity.
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver behavioral distress symptoms
Time Frame: Baseline and 6 months
Change in caregiver behavioral distress symptoms from baseline to 6 months as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q).If any of 12 care recipient behavioral symptoms is present in the last month (e.g., repeating, delusions), caregivers rate their own distress on a 6-point scale (Not at All-Extreme). A distress summary score is calculated by adding the scores of all items, with scores ranging from 0 to 60. Higher scores indicate higher distress.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

University of Miami
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
University of Puerto Rico

Investigators

  • Principal Investigator: Jaime Perales Puchalt, PhD, MPH, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150585
  • 1R01AG082306 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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