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

NCT06324981 | Recruiting DMC

• 2 other identifiers: 22-20971UG3HL168504
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cardiovascular Diseases; Lifestyle Factors

Keywords

cardiovascular disease; Life's Essential 8; mHealth

Outcome Measures

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.

  Baseline and 12 months after randomization

Secondary Outcomes (16)

• Blood pressure (Individual Life's Essential 8 components)

  Baseline and 12 months after randomization

• Total cholesterol (Individual Life's Essential 8 components)

  Baseline and 12 months after randomization

• Blood sugar (Individual Life's Essential 8 components)

  Baseline and 12 months after randomization

• Body Mass Index (Individual Life's Essential 8 components)

  Baseline and 12 months after randomization

• Physical activity (Individual Life's Essential 8 components)

  Baseline and 12 months after randomization

Study Arms (3)

Generic text messages

ACTIVE COMPARATOR

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.

Behavioral: Generic text messages

Interactive AI chatbot text messaging

ACTIVE COMPARATOR

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.

Behavioral: Proactive pharmacist support

Interactive AI chatbot text messaging + proactive pharmacist management

ACTIVE COMPARATOR

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.

Behavioral: Interactive AI chatbot text messaging; Behavioral: Proactive pharmacist support

Interventions

Generic text messages BEHAVIORAL

The same unidirectional text message will be sent each week for 9 weeks.

Generic text messages

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.

Interactive AI chatbot text messaging + proactive pharmacist management

Proactive pharmacist support BEHAVIORAL

Pharmacists that will proactively facilitate effective engagement with patients.

Interactive AI chatbot text messaging; Interactive AI chatbot text messaging + proactive pharmacist management

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Denver Health

Denver, Colorado, 80204, United States

RECRUITING

Salud Family Health Centers

Fort Lupton, Colorado, 80621, United States

NOT YET RECRUITING

STRIDE Community Health Centers

Wheat Ridge, Colorado, 80033, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• P. Michael Ho, MD PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Sandy, MA

CONTACT

570-594-1564; lisa.sandy@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: March 22, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)