288 Participants Needed

CuidaTEXT for Alzheimer's Disease

(CuidaTEXT R01 Trial)

RR
JP
Overseen ByJaime Perales Puchalt, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on caregiver support through text messaging, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment CuidaTEXT for Alzheimer's Disease?

The research highlights that technological solutions, like digital devices and apps, can help manage Alzheimer's symptoms by improving mood, memory, and daily activities. These tools show promise in enhancing the quality of life for patients and caregivers, suggesting that similar approaches in CuidaTEXT could be effective.12345

How is the treatment CuidaTEXT for Alzheimer's disease different from other treatments?

CuidaTEXT is unique because it likely involves a mobile app or software designed to engage Alzheimer's patients in meaningful activities, potentially slowing cognitive decline, unlike traditional drug treatments that focus on symptom management.678910

What is the purpose of this trial?

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.

Research Team

JP

Jaime Perales Puchalt, PhD, MPH

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for Latino caregivers over 18 years old who are providing hands-on care to a relative diagnosed with Alzheimer's or related dementia, indicated by an AD-8 score ≥2. Participants must have some depressive symptoms (CESD-10 score ≥7), be able to read and write, use text messaging weekly on their own cell phone, and speak Spanish or English.

Inclusion Criteria

My depression score is 7 or higher on the CESD-10 scale.
* Over the age of 18
* 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
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CuidaTEXT intervention, which includes a variety of text messages regarding ADRD education, social support, self-care, ADRD care management, and behavioral symptoms

6 months

Follow-up

Participants are monitored for changes in caregiver depressive symptoms and behavioral distress symptoms

1 month

Waitlist Control

Participants in the control group are offered the opportunity to start CuidaTEXT after their 7-month follow-up assessment

7 months

Treatment Details

Interventions

  • CuidaTEXT
Trial Overview The study tests CuidaTEXT, a text message-based support intervention for Latino caregivers of Alzheimer's patients. It aims to see if this approach can reduce caregiver stress and its negative effects by sending educational texts about dementia care, social support messages, self-care tips, and guidance on managing behavioral symptoms.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: CuidaTEXTExperimental Treatment1 Intervention
6 months of CuidaTEXT intervention + 1-month post-treatment
Group II: 7-Month Waitlist ControlActive Control1 Intervention
Participants allocated to this arm will be offered the opportunity to start CuidaTEXT immediately after their 7 Month follow-up assessment

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

University of Puerto Rico

Collaborator

Trials
69
Recruited
22,300+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials
933
Recruited
579,000+

University of Miami

Collaborator

Trials
976
Recruited
423,000+

Findings from Research

Recent discussions among physicians emphasize that evaluating Alzheimer's disease treatments should go beyond just cognitive improvements to include functional abilities, behavior, caregiver burden, quality of life, and resource utilization, as these factors significantly impact patients and caregivers.
Cholinesterase inhibitors have been shown to provide meaningful long-term benefits across multiple domains in Alzheimer's patients when using these expanded criteria for treatment success, highlighting their efficacy in improving overall patient well-being.
Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success?Winblad, B., Brodaty, H., Gauthier, S., et al.[2022]
Recent technological advancements, including digital devices and apps, show promise for improving the diagnosis, management, and treatment of Alzheimer's disease symptoms, based on a review of eight studies published in the last decade.
These technologies can help detect early cognitive deficits, enhance patient responsiveness, and support memory retrieval and spatial cognition, although more randomized controlled trials are needed to validate their effectiveness.
Technological Solutions for Diagnosis, Management and Treatment of Alzheimer's Disease-Related Symptoms: A Structured Review of the Recent Scientific Literature.Cammisuli, DM., Cipriani, G., Castelnuovo, G.[2022]
Acetylcholinesterase inhibitors (AChEIs) are effective in improving cognitive decline in mild to moderate Alzheimer's disease, as confirmed by real-world data from the CRONOS project involving about 500 Alzheimer Evaluation Units.
While atypical antipsychotics can be safer alternatives for treating behavioral and psychological symptoms of dementia (BPSD) compared to traditional neuroleptics, their use is limited due to an increased risk of cerebrovascular accidents.
Pharmacological treatment of Alzheimer's Disease.Bianchetti, A., Ranieri, P., Margiotta, A., et al.[2019]

References

Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success? [2022]
Technological Solutions for Diagnosis, Management and Treatment of Alzheimer's Disease-Related Symptoms: A Structured Review of the Recent Scientific Literature. [2022]
Pharmacological treatment of Alzheimer's Disease. [2019]
Complex educational and care (geron)technology for elderly individuals/families experiencing Alzheimer's disease. [2018]
Enhancing the communication flow between Alzheimer patients, caregivers, and neuropsychologists. [2017]
In Quest of Tablet Apps for Elders With Alzheimer's Disease: A Descriptive Review. [2023]
Development of mobile compatible software for cognitive-communication disorder in individuals with Alzheimer's disease. [2023]
Alzheimer's disease. [2010]
Differentiating Alzheimer's disease from mild cognitive impairment: a quick screening tool based on machine learning. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Review of the Content and Quality of Mobile Applications About Alzheimer's Disease and Related Dementias. [2023]
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