Recruiting

AI Text Messaging

Sponsor:

University of Colorado, Denver

Code:

NCT06324981

Conditions

Cardiovascular Diseases

Lifestyle Factors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Generic text messages

Interactive AI chatbot text messaging

Proactive pharmacist support

Study Details

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

Study ID

NCT06324981

Start date

Feb 26, 2024

Status verified date

Mar, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Generic text messages

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

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.

Proactive pharmacist support

Pharmacists that will proactively facilitate effective engagement with patients.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lisa Sandy, MA

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

Locations

Denver Health

Recruiting

Denver, Colorado, United States, 80204

Contacts

Pamela Peterson, MD MPH

pamela.peterson@dhha.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 22, 2024

Last verified

Mar, 2024

Keywords

  • cardiovascular disease
  • Life's Essential 8
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-03-22.