Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Colorado, Denver
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Generic text messages
BehavioralThe same unidirectional text message will be sent each week for 9 weeks.
Interactive AI chatbot text messaging
BehavioralEach 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
BehavioralPharmacists that will proactively facilitate effective engagement with patients.
Treatment groups
2,100 Participants
are divided into 3 treatment groupsGroup A: Generic text messagesActive comparator 1 intervention
Group B: Interactive AI chatbot text messagingActive comparator 1 intervention
Group C: Interactive AI chatbot text messaging + proactive pharmacist managementActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Life's Essential 8 risk score
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.
Time frame
Baseline and 12 months after randomizationSecondary outcomes
1
Blood pressure (Individual Life's Essential 8 components)
Change in the individual risk factors of the Life's Essential 8 (LE8), including change in blood pressure (both Systolic and Diastolic Blood Pressure), between baseline and 12-months following enrollment will be assessed. Data will be derived from the EHR. For patients without a baseline measure derived from the EHR, the investigators will encourage patients to talk to their physician about obtaining a measure consistent with LE8 recommendations. For the 12-month measurement, the investigators will take the value closest to the 12-month post enrollment date with a 3-month window prior to and after the 12-month enrollment date. For the primary outcome composite score: 100 points: \<120/\<80 mm Hg; 0 points: ≥160 mm Hg or ≥100 mm Hg.
Time frame
Baseline and 12 months after randomization2
Total cholesterol (Individual Life's Essential 8 components)
Change in the individual risk factors of the Life's Essential 8, including change in total cholesterol, between baseline and 12-months following enrollment will be assessed. Data will be derived from the EHR. For patients without a baseline measure derived from the EHR, the investigators will encourage patients to talk to their physician about obtaining a measure consistent with LE8 recommendations. For the 12-month measurement, the investigators will take the value closest to the 12-month post enrollment date with a 3-month window prior to and after the 12-month enrollment date. For the primary outcome composite score: 100 points: \<130 mg/dL; 0 points: ≥220 mg/dL
Time frame
Baseline and 12 months after randomization3
Blood sugar (Individual Life's Essential 8 components)
Change in the individual risk factors of the Life's Essential 8, including change in blood sugar, between baseline and 12-months following enrollment will be assessed. Data will be derived from the EHR. For patients without a baseline measure derived from the EHR, the investigators will encourage patients to talk to their physician about obtaining a measure consistent with LE8 recommendations. For the 12-month measurement, the investigators will take the value closest to the 12-month post enrollment date with a 3-month window prior to and after the 12-month enrollment date. For the primary outcome composite score: 100 points: No history of diabetes and hemoglobin A1c \<5.7; 0 points: Diabetes with hemoglobin A1c ≥10.0
Time frame
Baseline and 12 months after randomization4
Body Mass Index (Individual Life's Essential 8 components)
Change in the individual risk factors of the Life's Essential 8, including change in body mass index, between baseline and 12-months following enrollment will be assessed. Data will be derived from the EHR. For patients without a baseline measure derived from the EHR, the investigators will encourage patients to talk to their physician about obtaining a measure consistent with LE8 recommendations. For the 12-month measurement, the investigators will take the value closest to the 12-month post enrollment date with a 3-month window prior to and after the 12-month enrollment date. For the primary outcome composite score: 100 points: Body mass index (kg/m2) \<25; 0 points: Body mass index (kg/m2) ≥40.0
Time frame
Baseline and 12 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov