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Behavioural Intervention
Generic text messages for Cardiovascular Disease
N/A
Recruiting
Led By P. Michael Ho, MD PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months after randomization
Awards & highlights
Study Summary
This trial aims to compare three different strategies - text messages, interactive chatbot messages, and chatbot messages with proactive pharmacist support - to see which one is most effective in reducing risk factors for cardiovascular disease
Who is the study for?
This trial is for patients with cardiovascular risk factors who face health disparities, such as ethnic minorities, those with limited English proficiency, and low-income individuals. The study aims to improve self-management of chronic diseases in these groups.Check my eligibility
What is being tested?
The trial compares three strategies to reduce cardiovascular disease risks: generic text messages, interactive AI chatbot messaging, and chatbot messages plus proactive pharmacist support. It uses the AHA's Life's Essential 8 metrics for evaluation.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like text messaging and pharmacist support rather than medications or medical procedures, there are no direct side effects associated with the interventions being tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Life's Essential 8 risk score
Secondary outcome measures
Blood pressure (Individual Life's Essential 8 components)
Blood sugar (Individual Life's Essential 8 components)
Body Mass Index (Individual Life's Essential 8 components)
+13 moreTrial Design
3Treatment groups
Active Control
Group I: Generic text messagesActive Control1 Intervention
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.
Group II: Interactive AI chatbot text messagingActive Control1 Intervention
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.
Group III: Interactive AI chatbot text messaging + proactive pharmacist managementActive Control2 Interventions
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.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,850,024 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,147,426 Total Patients Enrolled
P. Michael Ho, MD PhDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
14,573 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to be a part of this research trial?
"Eligible participants for this research study must exhibit specific lifestyle characteristics and fall within the age range of 18 to 89 years. The trial aims to enroll approximately 2100 individuals."
Answered by AI
Are potential participants currently able to apply for enrollment in this trial?
"As per information available on clinicaltrials.gov, this medical investigation is presently enrolling subjects. The trial was first listed on 2/26/2024 and most recently revised on 3/14/2024."
Answered by AI
Can individuals who have not yet reached the age of 18 participate in this medical study?
"Participants aged 18 and older, but not exceeding 89 years old, are eligible for enrollment in this trial."
Answered by AI
What is the current number of participants eligible for enrollment in this clinical research study?
"Indeed, the details on clinicaltrials.gov indicate that this particular medical trial is actively enrolling participants. The trial was initially posted on February 26th, 2024 and last modified on March 14th, 2024. Recruitment aims to include a total of 2100 patients from three distinct sites."
Answered by AI
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