CuidaTEXT for Alzheimer's Disease

(CuidaTEXT R01 Trial)

Overseen By Jaime Perales Puchalt, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Other trial, Cohabitation, Moving, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if CuidaTEXT, a text messaging support program, can reduce stress and negative effects for Latino caregivers of individuals with Alzheimer's or similar dementias. Participants will receive text messages about caregiving tips, self-care, and support. The study will compare the well-being of caregivers using CuidaTEXT with those not using it. The trial seeks Latino caregivers who speak English or Spanish, provide hands-on care for a relative with dementia, and use a cell phone for texting. As an unphased trial, this study offers caregivers a unique opportunity to access potentially helpful resources and contribute to valuable research.

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 prior data suggests that the CuidaTEXT intervention is safe for caregivers?

Previous studies have shown that CuidaTEXT is well-tolerated. This program sends text messages to caregivers, offering education, support, and resources for managing Alzheimer's and related dementias. No reports of negative effects have emerged from receiving these messages. As a non-invasive, text-based support system, CuidaTEXT is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CuidaTEXT for Alzheimer's disease because it offers a novel approach to supporting patients and their families. Unlike traditional treatments that primarily focus on slowing cognitive decline through medications, CuidaTEXT is a digital intervention designed to enhance communication and caregiving strategies. This method aims to improve the quality of life for patients and caregivers by providing practical, real-time support and guidance, which is not typically addressed by existing drug therapies.

What evidence suggests that CuidaTEXT is effective for Alzheimer's caregiving?

Studies have shown that CuidaTEXT, a text message support program, can assist caregivers of individuals with Alzheimer's and related dementias. In early tests, five Latinx caregivers found it easy to use, giving it an average score of 97 out of 100. Research suggests that the program may help reduce feelings of depression and stress while improving coping skills. In this trial, participants will either receive the CuidaTEXT intervention or be placed on a 7-month waitlist control. Participants who frequently used CuidaTEXT reported greater satisfaction with the program. These findings suggest that CuidaTEXT could be a useful tool for managing caregiver stress and its negative effects. ^{1 2 3 5 6}

Who Is on the Research Team?

Jaime Perales Puchalt, PhD, MPH

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CuidaTEXT Experimental Treatment 1 Intervention

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

Group II: 7-Month Waitlist Control Active Control 1 Intervention

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

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+

Published Research Related to This Trial

A review of 36 mobile applications related to Alzheimer's disease and related dementias found that most apps focus on caregiving (62.1%) and disease management (55.6%), indicating a strong emphasis on supporting caregivers and managing the disease.

The overall quality of these apps was acceptable, with those developed by healthcare-related organizations scoring higher than those from non-healthcare developers, suggesting that collaboration between ADRD experts and tech developers could enhance the effectiveness and reliability of these resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the Content and Quality of Mobile Applications About Alzheimer's Disease and Related Dementias. Choi, SK., Yelton, B., Ezeanya, VK., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of Alzheimer's Disease. Bianchetti, A., Ranieri, P., Margiotta, A., et al.[2019]

A new software application developed for Turkish-speaking individuals with Alzheimer's disease (AD) showed positive effects on cognitive-communication skills, particularly in grammar and orientation, even for those in the severe stage of the disease.

In a study involving 32 participants, those using the application alongside their usual pharmacological treatment demonstrated significant improvements in cognitive-communication skills compared to a control group that only received medication, highlighting the software's potential as a supportive intervention for AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of mobile compatible software for cognitive-communication disorder in individuals with Alzheimer's disease. Parlak, MM., Köse, A., Güç, M., et al.[2023]

A review of 83 mobile apps for elders with Alzheimer's and related dementias revealed that many apps focus on activities like games, music, and memory training, but often require high cognitive and physical abilities, such as eye-hand coordination.

To enhance engagement and positive experiences, it's important to adopt a person-centered approach when designing and selecting apps, considering the individual variability in cognitive and functional abilities among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Quest of Tablet Apps for Elders With Alzheimer's Disease: A Descriptive Review. Tak, SH.[2023]

A new screening tool called the ABC-Scale effectively differentiates Alzheimer's disease (AD) from mild cognitive impairment (MCI) by evaluating activities of daily living (ADL), behavioral and psychological symptoms (BPSD), and cognitive function, with an estimated completion time of just 18 minutes.

The study analyzed data from 458 patients and found that specific cognitive tasks, like the ADAS-cog word recognition task, were particularly important for distinguishing between AD and MCI, leading to improved sensitivity in the diagnostic models used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiating Alzheimer's disease from mild cognitive impairment: a quick screening tool based on machine learning. Lü, W., Zhang, M., Yu, W., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success? Winblad, B., Brodaty, H., Gauthier, S., et al.[2022]

Alzheimer's disease (AD) is a leading cause of dementia affecting approximately 4.5 million people in the U.S., with projections suggesting this number could rise to 14 million by 2050, highlighting the urgent need for effective interventions.

Current treatments for AD provide only modest benefits and do not significantly alter the progression of the disease, emphasizing the importance of caregiver support and additional social services for managing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's disease. Yaari, R., Corey-Bloom, J.[2010]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Integrated Multidisciplinary Care Group for caregivers of individuals with Alzheimer's disease provides essential education and support, enhancing caregivers' knowledge and skills in managing care for elderly patients.

Through qualitative interviews with 13 family members, the study highlights that participation in the group fosters socialization and knowledge exchange, ultimately improving the quality of care for those with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex educational and care (geron)technology for elderly individuals/families experiencing Alzheimer's disease. Ilha, S., Santos, SSC., Backes, DS., et al.[2018]

Mnemosine is a proposed software environment aimed at improving the quality of life for both Alzheimer's patients and their caregivers by enhancing communication and providing resources for disease monitoring.

The software includes features like alarms, agenda management, GPS guidance, and progress reports, which can help manage daily activities and track the progression of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the communication flow between Alzheimer patients, caregivers, and neuropsychologists. Rodriguez-Rodriguez, A., Martel-Monagas, L., Lopez-Rodriguez, A.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10119327/

A Text Message Intervention to Support Latino Dementia ... CuidaTEXT is a bilingual, six-month intervention tailored to caregiver needs via SMS text messages. CuidaTEXT is bidirectional, as participants receive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06728436

Testing the Effects of a Text Message Caregiver Support ... 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 ...

3. kumc.edu kumc.edu/about/news/news-archive/text-message-intervention.html

NIH-funded study to test the effects of first text-message ... If the researchers' hypothesis is correct that CuidaTEXT is effective in reducing depression and distress and improving how caregivers cope, ...

4. medrxiv.org medrxiv.org/content/10.1101/2023.12.06.23299630v1.full-text

Analysis of Engagement with CuidaTEXT, a Text Message ... Results Participants sent a total of 1,847 messages to CuidaTEXT. Higher engagement was associated with higher intervention satisfaction (r=0.6, ...

5. aging.jmir.org aging.jmir.org/2022/2/e35625/

A Text Messaging Intervention to Support Latinx Family ... The 5 Latinx caregivers who used the prototype of CuidaTEXT scored an average of 97 out of 100 on the System Usability Scale. Conclusions: ...

6. medrxiv.org medrxiv.org/content/10.1101/2022.04.12.22273809v1

A Text Message Intervention to Support Latino Dementia ... CuidaTEXT is a six-month, bilingual, and bidirectional intervention tailored to caregiver needs (eg, education, problem-solving, resources).