Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06324981
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Lifestyle Factors

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Generic text messages — BEHAVIORAL
    The same unidirectional text message will be sent each week for 9 weeks.
  • Interactive AI chatbot text messaging — BEHAVIORAL
    Each week for 9 weeks, patients will be sent four messages that are specific to the LE8 topic for that week and with each message, they will be invited to engage with the chatbot to ask more questions about that topic. The first message of the week will be informational about the topic consistent with how the AHA provides information: 1) to understand readings and levels, 2) to encourage people to track levels, and 3) to offer specific skills building strategies. The fourth message will ask them to report out on short term (i.e., things they can do that week) plans for self-management for that topic and again invite their engagement with the chatbot to reinforce support for their plans.
  • Proactive pharmacist support — BEHAVIORAL
    Pharmacists that will proactively facilitate effective engagement with patients.

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Mar 2024
Primary completion
Feb 29, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
2,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Generic text messages
    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.
  • Active Comparator: Interactive AI chatbot text messaging
    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.
  • Active Comparator: Interactive AI chatbot text messaging + proactive pharmacist management
    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.

Primary Outcome Measure

Change in Life's Essential 8 risk score [ Time Frame: Baseline and 12 months after randomization ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Denver HealthDenverColorado80204
Pamela Peterson, MD MPH
[email protected]
Salud Family Health CentersFort LuptonColorado80621
Emily Kosirog, PharmD
[email protected]
STRIDE Community Health CentersWheat RidgeColorado80033
Danielle Montoya, PharmD
[email protected]

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By research site
Denver Health· Denver, COSalud Family Health Centers· Fort Lupton, COSTRIDE Community Health Centers· Wheat Ridge, CO

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