Only 1400 spots left

~1400 spots leftby Feb 2028

AI Text Messaging for Cardiovascular Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMichael Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: No cellphone, Hospice, Non-English/Spanish, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking. This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes. The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes. The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center. The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study focuses on improving medication adherence, it is likely that you will continue your current medications.

What data supports the effectiveness of AI Text Messaging for Cardiovascular Disease treatment?

Research shows that personalized text messages can help patients remember to take their medications, which is important for managing chronic conditions like cardiovascular disease. Additionally, using technology to assist pharmacists in communicating with doctors has improved medication adherence in heart disease patients.¹ ² ³ ⁴ ⁵

How is the AI Text Messaging treatment for cardiovascular disease different from other treatments?

The AI Text Messaging treatment is unique because it uses interactive chatbot messages and proactive pharmacist support to encourage medication adherence and lifestyle changes, which can be delivered automatically at scale. This approach is different from traditional treatments as it provides personalized, engaging, and supportive communication to motivate patients, potentially improving adherence and health outcomes.¹ ⁴ ⁶ ⁷ ⁸

Research Team

Michael Ho, MD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for patients with cardiovascular risk factors who face health disparities, such as ethnic minorities, those with limited English proficiency, and low-income individuals. The study aims to improve self-management of chronic diseases in these groups.

Inclusion Criteria

The risk factor is at poor or intermediate health levels as defined by LE8 (e.g., BP>140/90 mm Hg)

I have been late refilling my heart risk medication in the last 6 months.

I have been diagnosed with hypertension, diabetes, or high cholesterol.

Exclusion Criteria

Patients who do not have a cellphone

I am enrolled in hospice or palliative care.

I do not speak English or Spanish.

See 1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Pilot

Development of AI chatbot infrastructure and pilot study to assess feasibility

12 months

Stakeholder meetings and pilot study sessions

Randomized Intervention

Conduct a pragmatic patient-level randomized intervention of 3 text messaging delivery strategies for self-management support of CV risk factors

36 months

Regular virtual interactions via text messaging

Follow-up

Participants are monitored for changes in Life's Essential 8 health score and other secondary outcomes

12 months

Data collection at baseline and 12 months

Treatment Details

Interventions

AI Text Messaging (Behavioural Intervention)

Trial OverviewThe trial compares three strategies to reduce cardiovascular disease risks: generic text messages, interactive AI chatbot messaging, and chatbot messages plus proactive pharmacist support. It uses the AHA's Life's Essential 8 metrics for evaluation.

Participant Groups

3Treatment groups

Active Control

Group I: Generic text messagesActive Control1 Intervention

The information content for these messages will be derived from trusted sources of medical information and contain links to websites such as American Heart Association. An example of such a message would be: Remember to take your blood pressure today! You can find more information from the American Heart Association by clicking here. Patients will be able to return texts with questions which will be addressed by the study team, including a clinical pharmacist if needed.

Group II: Interactive AI chatbot text messagingActive Control1 Intervention

This AI system will utilize NLP and ML to facilitate bi-directional system-patient dialogue with messages that incorporate content utilizing tailoring, behavioral nudges and persuasive messaging as described above. An example message would be: Make a promise to yourself to check your blood pressure today! Your goal is to have the top number at 120 or lower and the bottom number at 80 or lower. Each message will end with a question for the participant that will encourage engagement with the AI conversational chatbot that allows greater opportunity to use theoretical content to engage patient autonomy, competence and relatedness, the mechanisms through which we will impact behaviors.

Group III: Interactive AI chatbot text messaging + proactive pharmacist managementActive Control2 Interventions

The AI chatbot will be the same as arm 2 (Interactive AI chatbot text messaging alone). In this arm, however, pharmacists will review patient's baseline LE8 risk factors and proactively contact patients via telephone and/or the EHR patient portal to address any risk factor that is in poor/intermediate health categories. The investigators are proposing proactive pharmacist involvement as a population-based approach to address patients with uncontrolled CV risk factors.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Salud Family Health CentersFort Lupton, CO

Denver HealthDenver, CO

STRIDE Community Health CentersWheat Ridge, CO

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Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1842

Patients Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews.Waughtal, J., Luong, P., Sandy, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirming the theoretical structure of expert-developed text messages to improve adherence to anti-hypertensive medications.Farris, KB., Salgado, TM., Batra, P., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to coronary heart disease secondary prevention medication guidelines at a community hospital.Bailey, TC., Noirot, LA., Gage, BF., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Communication of Global Cardiovascular Risk by Avatars.Ruiz, JG., Andrade, AD., Karanam, C., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messages for primary prevention of cardiovascular disease: The TextMe2 randomized clinical trial.Klimis, H., Thiagalingam, A., McIntyre, D., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart-to-heart with ChatGPT: the impact of patients consulting AI for cardiovascular health advice.Lautrup, AD., Hyrup, T., Schneider-Kamp, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversational Agents and Avatars for Cardiometabolic Risk Factors and Lifestyle-Related Behaviors: Scoping Review.Lyzwinski, LN., Elgendi, M., Menon, C.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on Healthcare Artificial Intelligent Conversational Agents for Chronic Conditions.Bin Sawad, A., Narayan, B., Alnefaie, A., et al.[2022]