Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications

December 4, 2023 updated by: University of Colorado, Denver

Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)

The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Up to fifty percent of patients do not take their cardiovascular medications as prescribed resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an intriguing and as of yet untested opportunity to adapt behavioral 'nudges' using ubiquitous cell phone technology to facilitate medication adherence.

Objectives: Aim 1: Conduct a pragmatic patient-level randomized intervention across three health care systems (HCS) to improve adherence to chronic CV medications. The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Secondary outcomes will include intermediate clinical measures (e.g., BP control), CV clinical events (e.g., hospitalizations), healthcare utilization, and costs. Aim 2: Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, assess the context and implementation processes to inform local tailoring, adaptations and modifications, and eventual expansion of the intervention within the 3 HCS more broadly and nationally.

Setting: The study will be conducted within three HCS in metro Denver: VA Eastern Colorado Health Care System (VA), Denver Health and Hospital Authority, and UCHealth.

Study Type

Interventional

Enrollment (Actual)

9501

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
      • Aurora, Colorado, United States, 80045
        • UCHealth
      • Aurora, Colorado, United States, 80045
        • VA Eastern Colorado Health Care System
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with the following cardiovascular conditions and respective medication classes:
  • Hypertension (Beta-blockers [B-blockers)], Calcium Channel Blocker [CCB], Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers [ARB], or Thiazide diuretic)
  • Hyperlipidemia (HMG CoA reductase inhibitor [Statins])
  • Diabetes (Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins Coronary artery disease P2Y12 inhibitor [Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine], B-blockers, ACEi or ARB or statins)
  • Atrial fibrillation (Direct oral anticoagulants, B-blockers, CCB)

Exclusion Criteria:

  • Patients who do not have a mailing address listed in EHR;
  • Patients who do not have a landline or cellphone listed in EHR;
  • Currently pregnant if denoted in the EHR at the time of the data pull;
  • Patients with a mailing address outside of the state of Colorado;
  • Patients that do not speak either English or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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.
Experimental: Generic Nudge
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.
Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Experimental: Optimized nudge
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.
Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Experimental: Optimized nudge plus AI Chat Bot
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.
Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: Up to 12 months after intervention
The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data.
Up to 12 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Up to 12 months after intervention
Blood pressure (systolic and diastolic) measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
Up to 12 months after intervention
Low-density lipoproteins (LDL)
Time Frame: Up to 12 months after intervention
LDL measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
Up to 12 months after intervention
Hemoglobin A1c
Time Frame: Up to 12 months after intervention
Hemoglobin A1c measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
Up to 12 months after intervention
Hospitalizations rate (Cardiovascular clinical events)
Time Frame: Up to 12 months after intervention
Hospitalizations due to hypertension emergency, myocardial infarction (MI), stroke, heart failure, hyperglycemia, and atrial fibrillation, are identified by an inpatient stay in the year following study enrollment.
Up to 12 months after intervention
Emergency Department admission rates (Cardiovascular clinical events)
Time Frame: Up to 12 months after intervention
Emergency Department admissions due to hypertension emergency, myocardial infarction (MI), stroke, heart failure, hyperglycemia, and atrial fibrillation are identified by an event in the year following study enrollment.
Up to 12 months after intervention
Percutaneous coronary intervention (PCI) rates, (Cardiovascular clinical events)
Time Frame: Up to 12 months after intervention
PCI are identified by a procedure in the year following study enrollment.
Up to 12 months after intervention
Coronary artery bypass graft (CABG) rates, (Cardiovascular clinical events)
Time Frame: Up to 12 months after intervention
CABG are identified by a procedure in the year following study enrollment.
Up to 12 months after intervention
Cardioversion rates (Cardiovascular clinical events)
Time Frame: Up to 12 months after intervention
Cardioversion are identified by a procedure in the year following study enrollment.
Up to 12 months after intervention
All-cause hospitalizations (Hospitalizations)
Time Frame: Up to 12 months after intervention
All-cause hospitalizations are identified by an inpatient stay in the year following study enrollment
Up to 12 months after intervention
All-cause Emergency Department admissions (Hospitalizations)
Time Frame: Up to 12 months after intervention
All-cause Emergency Department admissions are identified by an event in the year following study enrollment
Up to 12 months after intervention
Implementation costs (Costs)
Time Frame: Up to 12 months after intervention
The total cost of implementing each intervention to inform the resource use and investment required of each intervention.
Up to 12 months after intervention
Healthcare utilization costs (Costs)
Time Frame: Up to 12 months after intervention
Healthcare costs and cost offsets associated with the intervention to inform if there were reductions in healthcare utilization.
Up to 12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michael Ho, MD, PhD, University of Colorado, Denver
  • Principal Investigator: Sheana Bull, PhD, MPH, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-2779
  • UH3HL144163 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected as part of this project will be released in accordance with standard data sharing policies and procedures. Data will be made available to the broader scientific community after results are published in peer-reviewed journals.

Prior to making this data available, data will be redacted to strip identifiers and further de-identified by removing indirect identifiers that could lead to "deductive disclosure" of identities.

Due to the small numbers of participants in the qualitative interviews, we do not anticipate sharing raw data from individuals.

The agreement will prohibit the recipient from transferring the data to other users, require that the data's security be protected by standard means and be used for research purposes only. After a requestor completes the data-sharing agreement, we will either mail a CD with a limited dataset to the requestor, or email the data through our secure email system that requires users to create an account to receive sensitive data.

IPD Sharing Time Frame

Data will be shared in a timely manner, as requested.

IPD Sharing Access Criteria

The study team will share technical and practical knowledge regarding the creation of the chat bot and text messaging intervention, upon request. Further, the study team would readily share all data collection instruments and assessment algorithms used in the project to qualified individuals within the scientific community with the agreement that they will appropriately acknowledge the study team who developed the instruments.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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