Testing the Effects of a Text Message Caregiver Support Intervention for Latinos
CuidaTEXT R01
2 other identifiers
interventional
288
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Feb 2025
Longer than P75 for not_applicable alzheimer-disease
1 active site
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
First Submitted
Initial submission to the registry
December 6, 2024
CompletedFirst Posted
Study publicly available on registry
December 11, 2024
CompletedStudy Start
First participant enrolled
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
December 11, 2025
December 1, 2025
4.2 years
December 6, 2024
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
EXPERIMENTAL6 months of CuidaTEXT intervention + 1-month post-treatment
7-Month Waitlist Control
NO INTERVENTIONParticipants allocated to this arm will be offered the opportunity to start CuidaTEXT immediately after their 7 Month follow-up assessment
Interventions
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.
Eligibility Criteria
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
- Icahn School of Medicine at Mount Sinaicollaborator
- University of Miamicollaborator
- University of Kansas Medical Centerlead
- National Institute on Aging (NIA)collaborator
- University of Puerto Ricocollaborator
Study Sites (1)
University of Kansas Medical Center
Fairway, Kansas, 66205, United States
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.
PMID: 41001476DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Perales Puchalt, PhD, MPH
University of Kansas Medical Center
Central Study Contacts
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