Using artificially intelligent text messaging technology to improve American Heart Association's Life's Essential 8 Health Behaviors: Chat 4 Heart Health

Half of patients in the US over 45 have two or more chronic medical conditions. Managing these conditions can be difficult, and if not done correctly it can lead to increased medical risk or even death. Our study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients improve healthy behaviors to manage chronic cardiovascular conditions.

Our research team will identify patients with chronic cardiovascular conditions that have one or more risk factors address in the Life Essential 8 from the American Heart Association. Our research team will confirm that you would like to receive text messages by you texting the word “HEART” to 303-459-4346 to opt in. We will also send one text message asking if you want to receive text messages. If we do not hear from you we will call you to ask if you would like the receive the text messages. Once you are in the study you will be randomized into one of three arms by our study team: generic, interactive chatbot, or interactive chatbot with pharmacist support. You will receive 5 messages for 9 weeks on different health topics and they type of message will change based on each arm.

If you choose to not take part in the study now, please “opt out” by filling out and mailing back the enclosed form. No data will be collected by the study team if you decide to opt out now.

At any time, participants can text STOP to stop receiving the messages. The data that would otherwise be collected by your healthcare provider will continue to be viewed by the Chat 4 Heart Health team after the intervention.

Only patients that have a cell phone with texting capabilities can take part in the study.

We are interested to learn if text messages and chat bots are better than current methods to help patients with increase their heart health. We will measure patients’ overall Life’s Essential 8 scores, and see if it improves after messages are sent.

These measures are mostly results from your doctor’s visits. Results may include blood pressure levels and blood pressure control. We will also monitor patients for emergency department visits and hospitalizations. An additional measure will include a short survey that will be sent to patients four times via text message: at the beginning, 10 weeks in, 25 weeks in, and end of the study.

This study will start in the <DATE> and will end <DATE> . We will only enroll patients between the <DATE> and <DATE>.

To “opt out” means you do not want to be enrolled in this research study. In order to opt out of the study, you need to fill out the enclosed form and mail it back in the included envelope. If you cannot send the documents, please give us a call at 303-724-5692 or email us at c4hstudy@cuanschutz.edu.

This research is being paid for by a grant from the National Institutes of Health (NIH) Health Care Systems Research Collaboratory.

Our study will include patients at Denver Health, Salud Family Health Centers, and STRIDE Community Health Centers that have been diagnosed with a chronic cardiovascular condition including hypertension, hyperlipidemia, and diabetes.

Only the study team will see your responses to the messages. We will not share your responses with anyone outside of the study team. Depending on the type of messages you receive, a pharmacist from your healthcare system may reach out to you to offer support managing your chronic cardiovascular condition.

The study team at the University of Colorado Anschutz Medical Campus has developed message responses that reflect the advice of the American Heart Association to improve healthy behaviors.

You may receive messages to help you improve healthy behaviors. Rates for receiving a text message would cost the same as when you receive other text messages.

No, these are messages from a research team.

You will receive one $5 gift card for completing the survey sent to you via text when you opt into receiving text messages.

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You will receive one $5 gift card for completing the survey sent to you via text at the end of receiving messages.

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You may also get invited to participate in a phone interview after the intervention of approximately 30 minutes. This interview will be recorded. If you are invited and agree to participate in the interviews, you will receive a gift card of $30.

You do not have to participate in this study if you do not want to. You can opt out or decide later to withdraw at any time. There will be no change in procedures performed compared to the standard care provided by your physician normally for your condition. To opt out, please complete the opt out consent form and send the enclosed letter.

Please feel free to contact Michael Ho, MD, PhD, by phone at 303.724.5692 or by email at c4hstudy@cuanschutz.edu.

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A description of this clinical trial will be available on https://www.ClinicalTrials.gov as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

All of our messages will state they are coming from the study.

One of the Principal Investigators (PIs) involved in this project, Dr. Sheana Bull, founded and owns Clinic Chat, the company responsible for sending messages as part of the intervention. The company was established with a licensing agreement to the University of Colorado (CU). This project represents a work that is a derivative of the original infrastructure and content for the Clinic Chat chatbot system. Clinic Chat grants the University of Colorado a non-exclusive, royalty-free license to use, reproduce, transmit, perform, and distribute this derivative work solely for its own internal use, or for educational and research purposes of University.