NCT06324981 · University of Colorado, Denver
Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Generic text messages
The same unidirectional text message will be sent each week for 9 weeks.
BEHAVIORAL
Interactive AI chatbot text messaging
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.
BEHAVIORAL
Proactive pharmacist support
Pharmacists that will proactively facilitate effective engagement with patients.
Primary outcome measures
Change in Life's Essential 8 risk score
Time frame: Baseline and 12 months after randomization
The primary outcome is change in Life's Essential 8 risk score from baseline and 12 months following randomization. The Life's Essential 8 (LE8) is a cardiovascular health score that uses a 0-100 scale. The score is calculated based on a participant's adherence to eight healthy lifestyle components: diet, physical activity, smoking habits, body mass index, total cholesterol, blood sugar, blood pressure, and sleep. Each component has scoring algorithm ranging from 0 to 100 points, allowing generation of a composite cardiovascular health score (the unweighted average of all components) that also varies from 0 to 100 points. 0 will indicate the lowest cardiovascular health scores and 100 will indicate the highest cardiovascular health scores.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- diagnosis of one or more of the following CV risk factors (i.e., hypertension, diabetes or hyperlipidemia); and
- the risk factor is at poor or intermediate health levels as defined by LE8 (e.g., BP\>140/90 mm Hg); and
- the patient exhibits poor adherence to prescribed medication to treat the CV risk factor as defined by a delay in refilling the medication within the past 6 months.
Exclusion criteria
- patients who do not have cellphone; or
- enrolled in hospice or palliative care; or
- Non-English or Spanish speaking; or
- enrolled in another clinical trial if denoted in the EHR.
Where
- Denver, Colorado
- Fort Lupton, Colorado
- Wheat Ridge, Colorado
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 22, 2024 · Source of record for eligibility and locations