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NCT03973931

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

Completed NA Results posted Last updated 2 April 2025
What this trial tests

NA trial testing Nudge in Cardiovascular Diseases in 9,501 participants. Completed in 19 November 2023.

Timeline
1 July 2019
Primary endpoint
25 May 2023
19 November 2023

Quick facts

Lead sponsorUniversity of Colorado, Denver
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment9,501
Start date1 July 2019
Primary completion25 May 2023
Estimated completion19 November 2023
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 89, any sex, with Cardiovascular Diseases or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Adherence Primary · 12 months after intervention

The primary outcome was medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data adjusted difference from usual care.

GroupValue95% CI
Generic Nudge.606.594 – .618
Optimized Nudge.620.609 – .633
Optimized Nudge Plus AI Chat Bot.623.612 – .635
Usual Care.630.618 – .640
Mean Proportion of Days Covered Relative to Usual Care Primary · 12 months

We analyzed this longitudinal data (up to 12 observations per patient) and estimated absolute differences in PDC between treatment arms and usual care using a Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations .A multistage gatekeeper approach was used to account for multiple treatment comparisons by comparing each of the 3 treatment arms to the control in stage 1 using significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm m

GroupValue95% CI
Generic Nudge0.0220.003 – 0.042
Optimized Nudge0.0200.001 – 0.039
Optimized Nudge Plus AI Chat Bot0.0230.004 – 0.042
Hospitalization Secondary · one year

estimated probability of hospitalization at one year

GroupValue95% CI
Generic Nudge.13.115 – .144
Optimized Nudge.136.121 – .151
Optimized Nudge Plus AI Chat Bot.136.121 – .151
Usual Care.143.128 – .158
Death Secondary · one year

estimated probability of death at one year

GroupValue95% CI
Generic Nudge.031.03 – .039
Optimized Nudge.026.019 – .033
Optimized Nudge Plus AI Chat Bot.027.020 – .034
Usual Care.033.025 – .041
Emergency Department Visit Secondary · one year

estimated probability of emergency department visit at one year

GroupValue95% CI
Generic Nudge.292.272 – .311
Optimized Nudge.285.265 – .305
Optimized Nudge Plus AI Chat Bot.294.274 – .313
Usual Care.301.281 – .321

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Generic Nudge
Serious: 267/2324 (11%)
Deaths: 63/2324
Optimized Nudge
Serious: 283/2305 (12%)
Deaths: 53/2305
Optimized Nudge Plus AI Chat Bot
Serious: 283/2319 (12%)
Deaths: 55/2319
Usual Care
Serious: 303/2321 (13%)
Deaths: 68/2321

Serious adverse events (1 terms)

ReactionSystemGeneric NudgeOptimized NudgeOptimized Nudge Plus AI Ch…Usual Care
Number with All Cause Hospitalization in 12 monthsGeneral disorders
Other adverse events (1 terms — click to expand)

ReactionSystemGeneric NudgeOptimized NudgeOptimized Nudge Plus AI Ch…Usual Care
Number with Emergency Department visits in 12 monthsGeneral disorders

Most-reported serious reactions: Number with All Cause Hospitalization in 12 months.

Data from ClinicalTrials.gov NCT03973931 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory.
    Richesson RL, Marsolo KS, Douthit BJ, Staman K, et al · · 2021 · cited 41× · PMID 34597383 · DOI 10.1093/jamia/ocab202
  2. Nudging within learning health systems: next generation decision support to improve cardiovascular care.
    Chen Y, Harris S, Rogers Y, Ahmad T, et al · · 2022 · cited 27× · PMID 35139182 · DOI 10.1093/eurheartj/ehac030
  3. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.
    Palmer MJ, Machiyama K, Woodd S, Gubijev A, et al · · 2021 · cited 25× · PMID 33769555 · DOI 10.1002/14651858.cd012675.pub3
  4. The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial.
    Glasgow RE, Knoepke CE, Magid D, Grunwald GK, et al · · 2021 · cited 21× · PMID 34380527 · DOI 10.1186/s13063-021-05453-9
  5. Text Message Medication Adherence Reminders Automated and Delivered at Scale Across Two Institutions: Testing the Nudge System: Pilot Study.
    Luong P, Glorioso TJ, Grunwald GK, Peterson P, et al · · 2021 · cited 21× · PMID 33993727 · DOI 10.1161/circoutcomes.120.007015
  6. Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial.
    Ho PM, Glorioso TJ, Allen LA, Blankenhorn R, et al · · 2025 · cited 17× · PMID 39621340 · DOI 10.1001/jama.2024.21739
  7. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.
    O'Brien EC, Sugarman J, Weinfurt KP, Larson EB, et al · · 2022 · cited 9× · PMID 35597988 · DOI 10.1186/s13063-022-06385-8
  8. Leave me out: Patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence.
    Sandy LC, Glorioso TJ, Weinfurt K, Sugarman J, et al · · 2021 · cited 5× · PMID 34941059 · DOI 10.1097/md.0000000000028136

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Currently open trials in the same condition.

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