What side effects are associated with this type of intervention?

Common treatments for type 2 diabetes include oral medications like metformin, insulin therapy, and newer agents such as GLP-1 receptor agonists (e.g., semaglutide). Metformin is generally well-tolerated but can cause gastrointestinal issues like nausea and diarrhea. Insulin therapy can lead to hypoglycemia and weight gain. GLP-1 receptor agonists may cause gastrointestinal side effects, including nausea and vomiting. Behavioral interventions, such as text message reminders, aim to improve medication adherence and typically have minimal direct side effects, though their effectiveness can vary.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of type 2 diabetes mellitus, including GLP-1 receptor agonists such as liraglutide, extended-release exenatide, and dulaglutide. These medications have shown efficacy in improving glycemic control and are often used in combination with lifestyle interventions like diet and exercise. Liraglutide and extended-release exenatide have been specifically approved for pediatric patients aged 10 years and older. While the context does not directly mention behavioral reminders or encouragement, these medications are often part of comprehensive diabetes management plans that may include such strategies to improve adherence.

What other types of research exist?

Promising alternatives to text message interventions for diabetes patients include mobile health applications, internet-based guided self-help programs, and smartphone applications that offer comprehensive diabetes management tools. These platforms can provide personalized feedback, real-time monitoring, and interactive educational content, which may enhance patient engagement and adherence to treatment plans.

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Behavioral Nudges for Medication Adherence in Cardiovascular Disease

N/A

Waitlist Available

Led By 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

Patients with hypertension and taking Beta-blockers, Calcium Channel Blocker, Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers (ARB), or Thiazide diuretic

Patients with diabetes and taking Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins

Must not have

Patients that do not speak either English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if sending text message reminders and encouragements can help patients with cardiovascular conditions take their medication more regularly. The study focuses on patients who often forget or have trouble keeping up with their medication. By using simple text messages, the researchers hope to improve medication adherence and overall health outcomes.

Who is the study for?

This trial is for patients in Colorado with conditions like atrial fibrillation, coronary artery disease, diabetes, high cholesterol, or high blood pressure. They must be taking specific medications for these conditions and have a phone and mailing address listed in their electronic health records.

What is being tested?

The study is testing whether personalized text message reminders can help people with chronic cardiovascular diseases take their medication regularly. It aims to see if this 'nudge' approach improves adherence to prescribed drug regimens.

What are the potential side effects?

Since the intervention involves sending text messages as reminders or encouragement without any medical procedures or drugs involved, there are no direct side effects associated with this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high blood pressure and am on medication like Beta-blockers or ACE inhibitors.

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I have diabetes and am on medication for it.

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I have heart disease and am taking specific heart medications.

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I have high cholesterol and am taking statins.

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I have atrial fibrillation and am on blood thinners or heart rate control medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medication adherence

Secondary study objectives

All-cause Emergency Department admissions (Hospitalizations)

All-cause hospitalizations (Hospitalizations)

Blood pressure

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Optimized nudge plus AI Chat BotExperimental Treatment1 Intervention

An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.

Group II: Optimized nudgeExperimental Treatment1 Intervention

An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.

Group III: Generic NudgeExperimental Treatment1 Intervention

A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.

Group IV: Usual CareActive Control1 Intervention

This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nudge

2022

N/A

~56380

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include lifestyle modifications, oral medications, and insulin therapy. Lifestyle changes such as diet and exercise improve insulin sensitivity and help manage weight, which is crucial for glycemic control. Metformin, a common oral medication, reduces glucose production in the liver and increases insulin sensitivity. Insulin therapy directly supplements the body's insulin levels, essential for glucose uptake by cells. Adherence to these treatments is vital for effective diabetes management, and behavioral interventions like text message reminders can significantly improve adherence by providing timely encouragement and information, ultimately leading to better glycemic control and reduced complications.

Behavior change interventions in patients with type 2 diabetes: a systematic review of the effects on self-management and A1c.Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States.Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis.