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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months after intervention

Awards & highlights

Study Summary

This trial will test if text messages help patients take their medication as prescribed.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medication adherence

Secondary outcome measures

All-cause Emergency Department admissions (Hospitalizations)

All-cause hospitalizations (Hospitalizations)

Blood pressure

+9 more

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

~8850

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,134,047 Total Patients Enrolled

17 Trials studying Diabetes

13,572 Patients Enrolled for Diabetes

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,296,995 Total Patients Enrolled

29 Trials studying Diabetes

51,820 Patients Enrolled for Diabetes

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

Diabetes Research Study Groups: Optimized nudge plus AI Chat Bot, Usual Care, Generic Nudge, Optimized nudge

Diabetes Clinical Trial 2023: Nudge Highlights & Side Effects. Trial Name: NCT03973931 — N/A

Nudge 2023 Treatment Timeline for Medical Study. Trial Name: NCT03973931 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which individuals is enrollment in this research project available?

"Qualified applicants for this trial must have a cardiovascular disorder and be aged between 18 and 89. The team is hoping to enrol 9501 individuals in total."

Answered by AI

Are there still openings available for this research study?

"Clinicaltrials.gov confirms that this research is not actively seeking enrolment, having first been posted on July 1st 2019 and last updated November 2nd 2022. However, there are over 3000 other studies currently recruiting patients at the present time."

Answered by AI