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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 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

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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,812,798 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,782,797 Total Patients Enrolled
Michael Ho, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
1,640 Total Patients Enrolled

Media Library

Nudge Clinical Trial Eligibility Overview. Trial Name: NCT03973931 — N/A
Cardiovascular Disease Research Study Groups: Optimized nudge plus AI Chat Bot, Usual Care, Generic Nudge, Optimized nudge
Cardiovascular Disease Clinical Trial 2023: Nudge Highlights & Side Effects. Trial Name: NCT03973931 — N/A
Nudge 2023 Treatment Timeline for Medical Study. Trial Name: NCT03973931 — N/A
~1481 spots leftby Dec 2025