An interventional study of Nudge in Cardiovascular Diseases, Adherence, Medication and Medication Adherence, sponsored by University of Colorado, Denver. Completed at 4 sites in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention
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.
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 include clinical events (e.g., event times for stroke, MI, mortality), utilization of care (e.g., hospitalizations or clinic visits for CV-related reasons), and costs of healthcare utilization. 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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 9,501 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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
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.
Medication Adherence
The primary outcome was medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data adjusted difference from usual care.
Time frame: 12 months after intervention
Mean Proportion of Days Covered Relative to Usual Care
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 method was used for the 3 pairwise comparisons, where R is the number of significant stage 1 tests.
Time frame: 12 months
Hospitalization
estimated probability of hospitalization at one year
Time frame: one year
Death
estimated probability of death at one year
Time frame: one year
Emergency Department Visit
estimated probability of emergency department visit at one year
Time frame: one year
| Milestone | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Started | 2377 | 2373 | 2375 | 2376 |
| Completed | 2324 | 2305 | 2319 | 2321 |
| Not completed | 53 | 68 | 56 | 55 |
| Withdrew: Lost to follow-up | 47 | 63 | 51 | 54 |
| Withdrew: Opted out | 6 | 5 | 5 | 1 |
The primary outcome was medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data adjusted difference from usual care.
| mean PDC | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Medication Adherence | .606 (.594 to .618) | .620 (.609 to .633) | .623 (.612 to .635) | .630 (.618 to .640) |
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 method was used for the 3 pairwise comparisons, where R is the number of significant stage 1 tests.
| proportion of days covered | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot |
|---|---|---|---|
| Mean Proportion of Days Covered Relative to Usual Care | 0.022 (0.003 to 0.042) | 0.020 (0.001 to 0.039) | 0.023 (0.004 to 0.042) |
estimated probability of hospitalization at one year
| estimated probability of hospitalization | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Hospitalization | .13 (.115 to .144) | .136 (.121 to .151) | .136 (.121 to .151) | .143 (.128 to .158) |
estimated probability of death at one year
| estimated probability of death | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Death | .031 (.03 to .039) | .026 (.019 to .033) | .027 (.020 to .034) | .033 (.025 to .041) |
estimated probability of emergency department visit at one year
| estimated probability of ED visit | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Emergency Department Visit | .292 (.272 to .311) | .285 (.265 to .305) | .294 (.274 to .313) | .301 (.281 to .321) |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Generic Nudge | 63/2,324 (2.7%) | 267/2,324 (11.5%) | 612/2,324 (26.3%) |
| Optimized Nudge | 53/2,305 (2.3%) | 283/2,305 (12.3%) | 594/2,305 (25.8%) |
| Optimized Nudge Plus AI Chat Bot | 55/2,319 (2.4%) | 283/2,319 (12.2%) | 616/2,319 (26.6%) |
| Usual Care | 68/2,321 (2.9%) | 303/2,321 (13.1%) | 639/2,321 (27.5%) |
| Event | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Number with All Cause Hospitalization in 12 monthsGeneral disorders | 267/2324 | 283/2305 | 283/2319 | 303/2321 |
| Event | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care |
|---|---|---|---|---|
| Number with Emergency Department visits in 12 monthsGeneral disorders | 612/2324 | 594/2305 | 616/2319 | 639/2321 |
| Age, Continuous(years) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Mean | 59.9 ± 12.5 | 60 ± 12.9 | 60.1 ± 12.7 | 60.1 ± 12.6 | 60.0 ± 12.7 |
| Sex: Female, Male(Participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Female | 1087 | 1075 | 1101 | 1088 | 4351 |
| Male | 1237 | 1230 | 1218 | 1233 | 4918 |
| Ethnicity (NIH/OMB)(Participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1100 | 1147 | 1168 | 1149 | 4564 |
| Not Hispanic or Latino | 1204 | 1141 | 1134 | 1150 | 4629 |
| Unknown or Not Reported | 20 | 17 | 17 | 22 | 76 |
| Race (NIH/OMB)(Participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 22 | 27 | 23 | 35 | 107 |
| Asian | 29 | 31 | 21 | 29 | 110 |
| Native Hawaiian or Other Pacific Islander | 3 | 2 | 6 | 3 | 14 |
| Black or African American | 391 | 378 | 356 | 392 | 1517 |
| White | 1601 | 1615 | 1646 | 1598 | 6460 |
| More than one race | 10 | 14 | 16 | 9 | 49 |
| Unknown or Not Reported | 268 | 238 | 251 | 255 | 1012 |
| Marital Status(Participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Married Married | 994 | 940 | 980 | 950 | 3864 |
| Single | 883 | 883 | 870 | 874 | 3510 |
| Divorced/Widowed | 434 | 464 | 452 | 483 | 1833 |
| Unknown | 13 | 18 | 17 | 14 | 62 |
| Insurance(Participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Medicare | 853 | 878 | 860 | 889 | 3480 |
| Medicaid | 659 | 632 | 629 | 665 | 2585 |
| Commercial | 463 | 471 | 500 | 441 | 1875 |
| Unknown | 123 | 96 | 130 | 112 | 461 |
| VHA | 8 | 7 | 8 | 12 | 35 |
| None | 218 | 221 | 192 | 202 | 833 |
| Medical History(participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Depression | 421 | 463 | 442 | 416 | 1742 |
| Chronic Kidney Disease | 191 | 202 | 203 | 189 | 785 |
| Heart Failure | 160 | 199 | 163 | 171 | 693 |
| Cerebrovascular Disease | 142 | 145 | 125 | 134 | 546 |
| Posttraumatic Stress Disorder | 118 | 114 | 102 | 108 | 442 |
| Substance Abuse | 89 | 101 | 116 | 88 | 394 |
| Prior Coronary Revascularization | 63 | 56 | 70 | 58 | 247 |
| Prior Myocardial Infarction | 95 | 109 | 121 | 98 | 423 |
| Qualifying Condition(participants) | Generic Nudge | Optimized Nudge | Optimized Nudge Plus AI Chat Bot | Usual Care | Total |
|---|---|---|---|---|---|
| Hypertension | 1837 | 1829 | 1821 | 1864 | 7351 |
| Diabetes | 1148 | 1164 | 1162 | 1149 | 4623 |
| Hyperlipidemia | 1072 | 1052 | 1089 | 1054 | 4267 |
| Coronary Artery Disease | 305 | 325 | 352 | 328 | 1310 |
| Atrial Fibrillation | 132 | 152 | 130 | 134 | 548 |
| >1 Qualifying Condition | 1406 | 1390 | 1410 | 1438 | 5644 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver