Cardiovascular Diseases Clinical Trial
Official title:
Using Artificially Intelligent Text Messaging Technology to Improve American Heart Association's Life's Essential 8 Health Behaviors: LE8 Bot + Backup
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.
Status | Recruiting |
Enrollment | 2100 |
Est. completion date | June 2028 |
Est. primary completion date | February 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health | Denver | Colorado |
United States | Salud Family Health Centers | Fort Lupton | Colorado |
United States | STRIDE Community Health Centers | Wheat Ridge | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
Baseline and 12 months after randomization | |
Secondary | 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 |
Baseline and 12 months after randomization | |
Secondary | 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 |
Baseline and 12 months after randomization | |
Secondary | 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 |
Baseline and 12 months after randomization | |
Secondary | Physical activity (Individual Life's Essential 8 components) | Change in the individual risk factors of the Life's Essential 8, including change in physical activity, between baseline and 12-months following enrollment will be assessed. Since physical activity is not observable in the EHR, the investigators will ask patients via text to self-report their status at baseline and 12-months following enrollment. Patients will be asked to report the total number of minutes of vigorous physical activity they get in a typical week, and the total number of minutes of moderate physical activity they get in a typical week. Patients can enter the number of minutes for each question, or can choose to skip the question or select "Prefer not to answer".
For the primary outcome composite score: 100 points: =150 minutes of moderate or vigorous activities per week; 0 points: 0 minutes |
Baseline and 12 months after randomization | |
Secondary | Sleep (Individual Life's Essential 8 components) | Change in the individual risk factors of the Life's Essential 8, including change in sleep, between baseline and 12-months following enrollment will be assessed. Since sleep is not observable in the EHR, the investigators will ask patients via text to self-report their status at baseline and 12-months following enrollment. Patients will be asked to report how many hours of sleep do you get per night on average. Patients can enter the number of hours, or can choose to skip the question or select "Prefer not to answer".
For the primary outcome composite score: 100 points: 7-<9 hours of sleep per night; 0 points: <4 hours of sleep per night. |
Baseline and 12 months after randomization | |
Secondary | Smoking habits (Individual Life's Essential 8 components) | Change in the individual risk factors of the Life's Essential 8, including change in smoking habits, between baseline and 12-months following enrollment will be assessed. Since smoking habits are not observable in the EHR, the investigators will ask patients via text to self-report their status at baseline and 12-months following enrollment. Patients will be asked if they smoke cigarettes, cigars, little cigars, pipes, water pipes, hookah, use e-cigarettes or any other tobacco product? Options may include Yes, No, Prefer not to answer, or Skip.
For the primary outcome composite score: 100 points: Never smoker; 0 points: Current smoker. |
Baseline and 12 months after randomization | |
Secondary | Health diet pattern (Individual Life's Essential 8 components) | Change in the individual risk factors of the Life's Essential 8, including change in diet patterns between baseline and 12-months following enrollment. As diet patterns are not observable in the EHR, the investigators will ask patients via text to self-report at baseline and 12-months following enrollment. The study will use the Mini-Eating Assessment Tool (Mini-EAT), a 9-item dietary screener that includes fruits/vegetables, whole grains, refined grains, fish/seafood, legumes/nuts/seeds, low-fat dairy, high-fat dairy, and sweets consumption. The 9-item survey will provide a single score (range 0-100; scores <61 indicate an unhealthy diet, 61-69 indicate an intermediate diet, >69 indicate a healthy diet).
For the primary outcome composite score: 100 points: =95th percentile (top/ideal diet); 0: 1st-24th percentile (bottom/least ideal quartile). |
Baseline and 12 months after randomization | |
Secondary | Self-Efficacy for Managing Chronic Diseases | The Self-Efficacy for Managing Chronic Disease Scale is a valid and reliable instrument available in English and Spanish. The English version is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). | Baseline and 12 months after randomization | |
Secondary | Number of medication refill gaps (Medication adherence) | The investigators will measure medication adherence in one of two ways. First, investigators will identify the number of gaps (frequency) for every patient and medication. Gaps will be determined using pharmacy refill data based on the date of refill, the number of days supplied, and the subsequent refill date during the 12-month intervention period. Worse medication adherence will be identified as an increase in the frequency of gaps. The study is currently using this same methodology in the Nudge study. | Baseline and 12 months after randomization | |
Secondary | Length of refill gaps (Medication adherence) | The investigators will measure medication adherence in one of two ways. In the second method, investigators will measure medication adherence by measuring the length of each gap (severity) for every patient and medication. The length of each gap will be determined using pharmacy refill data based on the date of refill, the number of days supplied, and the subsequent refill date during the 12-month intervention period. Worse medication adherence will be identified as the length (severity) of the gaps. We are currently using this same methodology in the Nudge study | Baseline and 12 months after randomization | |
Secondary | Clinic events | Clinical events are defined as emergency department (ED) visits or hospitalizations. | Baseline and 12 months after randomization | |
Secondary | Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score | Investigators will determine subsequent Coronary Heart Disease risk based on the following risk factors obtained via the Electronic Health Records and/or patient self-report: age, systolic blood pressure, cigarette smoking status, fasting lipid level (totals and HDL Cholesterol), and diagnosis of diabetes. Points are assigned based on the presence or level of risk factors, and will be converted to risk percentages using a conversion algorithm. The range is 0%-22%, with 0% being the lowest risk and 22% being the highest risk of recurrent coronary heart disease. This score will be calculated for patients who have had a prior CHD event at the time of study enrollment based on diagnosis codes of prior Coronary Heart Disease event or ischemic stroke. | Baseline and 12 months after randomization | |
Secondary | Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score | Investigators will determine the 2 year risk of Coronary Heart Disease in patients free of cardiovascular diseases at the time of study enrollment and include the following risk factors to be gathered via the Electronic Health Records or patient self-report: age, systolic blood pressure, cigarette smoking status, fasting lipid level (totals and HDL Cholesterol), diagnosis of diabetes, use of antihypertensive medication. Points are assigned based on the presence or level of risk factors, and can be converted to risk percentages using a conversion table. The range is 0%-43%, with 0% being the lowest risk and 43% being the highest risk of developing coronary heart disease. | Baseline and 12 months after randomization | |
Secondary | Rate of routine clinical visits and/or other procedures associated with the clinical condition | The study will also measure healthcare utilization defined by routine clinical visits and/or other procedures associated with the clinical condition. | Baseline and 12 months after randomization | |
Secondary | Cost | Medical care costs will be estimated using a resource-based method previously developed to assign costs to encounter data. Inpatient utilization will be measured using diagnostic-related groups (DRGs), outpatient utilization using relative value units (RVUs), and pharmacy utilization using average wholesale prices (AWPs). Inpatient costs will be estimated by applying national payment weights to DRGs, outpatient costs by applying a national conversion factor to RVUs, and pharmacy costs at 69% of the AWP during a reference year. Cost data will be analyzed using generalized gamma regression accounting for study arm and health system. The resources to both develop and implement the intervention will also be collected. | Baseline and 12 months after randomization |
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