Alzheimer DiseaseCuidaTEXT R01NCT06728436
Testing the Effects of a Text Message Caregiver Support Intervention for Latinos
A study testing CuidaTEXT in people with Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- CuidaTEXT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Fairway, Kansas, 66205
Rachel Ruiz, 913-945-5052, rruiz3@kumc.edu
Jaime Perales Puchalt, PhD, MPH
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- CuidaTEXT
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CuidaTEXTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CuidaTEXT | Experimental | 6 months of CuidaTEXT intervention + 1-month post-treatment Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in caregiver behavioral distress symptoms
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start17 Feb 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Puerto Rico, Icahn School of Medicine at Mount Sinai, University of Miami
- Responsible party
- Principal investigator, Jaime Perales Puchalt, PhD, MPH, University of Kansas Medical Center
- Investigators
- Jaime Perales Puchalt, PhD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728436
- Sponsor's protocol ID
- 150585
- Other IDs
- 1R01AG082306
- Acronym
- CuidaTEXT R01
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41001476
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of a Text Message Caregiver Support Intervention for Latinos
- ClinicalTrials.gov ID
- NCT06728436
- Acronym / sponsor ID
- CuidaTEXT R01 / 150585
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Puerto Rico, Icahn School of Medicine at Mount Sinai, University of Miami
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CuidaTEXT | Experimental | Behavioral: CuidaTEXT6 months of CuidaTEXT intervention + 1-month post-treatment |
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CuidaTEXTCuidaTEXT 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. | Behavioural | CuidaTEXT |
Primary outcome
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.
1 secondary outcome
Change in caregiver behavioral distress symptoms
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 41001476Perales-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.
Related trials for Alzheimer Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
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.
Jaime Perales Puchalt, PhD, MPH principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CuidaTEXT in people with Alzheimer Disease, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Ruiz (913-945-5052, rruiz3@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver depressive symptoms (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728436, which also lists 1 linked publication.
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 11 Dec 2025.