NCT06728436

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
36mo left

Started Feb 2025

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Feb 2025May 2029

First Submitted

Initial submission to the registry

December 6, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4.2 years

First QC Date

December 6, 2024

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in caregiver depressive symptoms

    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 Outcomes (1)

  • Change in caregiver behavioral distress symptoms

    Baseline and 6 months

Study Arms (2)

CuidaTEXT

EXPERIMENTAL

6 months of CuidaTEXT intervention + 1-month post-treatment

Behavioral: CuidaTEXT

7-Month Waitlist Control

NO INTERVENTION

Participants allocated to this arm will be offered the opportunity to start CuidaTEXT immediately after their 7 Month follow-up assessment

Interventions

CuidaTEXTBEHAVIORAL

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.

CuidaTEXT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

RECRUITING

Related Publications (1)

  • Perales-Puchalt J, Ramirez-Mantilla M, Moore HP, Velez-Uribe I, Sepulveda-Rivera V, Ruiz R, Fracachan-Cabrera M, Herrera Y, Baker C, Miras-Neira A, Bothwell B, Anderson H, Lewandowski T, Diaz FJ, Greiner KA, Williams K, Vidoni ED, Ellerbeck E, Burns JM. Testing the effects of a text message intervention on depression and distress among Latino dementia caregivers: a randomized controlled trial protocol. medRxiv [Preprint]. 2025 Sep 18:2025.09.16.25335909. doi: 10.1101/2025.09.16.25335909.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jaime Perales Puchalt, PhD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ruiz

CONTACT

Jaime Perales Puchalt, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 11, 2024

Study Start

February 17, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations