Cardiovascular DiseasesNCT03973931
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
A study testing Nudge in people with Cardiovascular Diseases and Adherence, Medication, run by University of Colorado, Denver at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Adherence, Medication, Medication Adherence
- What is being tested?
- Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,501 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2019to 19 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UCHealth
Aurora, Colorado, 80045
University of Colorado Denver
Aurora, Colorado, 80045
VA Eastern Colorado Health Care System
Aurora, Colorado, 80045
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Cardiovascular Diseases, Adherence, Medication, Medication Adherence, Diabetes Mellitus, Hypertension, Hyperlipidemias
- Being tested
- Nudge
- Keywords
- cardiovascular disease, telemedicine, medication adherence, behavioral health
- Medical subject headings
- Cardiovascular Diseases, Medication Adherence, Diabetes Mellitus, Hypertension, Hyperlipidemias, Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
Interventions will include a variety of text messages aimed at improving medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No 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. |
| Generic Nudge | Experimental | 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. Receives: Behavioral: Nudge |
| Optimized nudge | Experimental | 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. Receives: Behavioral: Nudge |
| Optimized nudge plus AI Chat Bot | Experimental | 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. Receives: Behavioral: Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
Hospitalization
estimated probability of hospitalization at one year
Measured: one year
Death
estimated probability of death at one year
Measured: one year
Emergency Department Visit
estimated probability of emergency department visit at one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jul 2019
- Primary completion25 May 2023
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a pragmatic, randomized controlled study with four treatment arms. Once patients are identified through pharmacy refill data to have a 7-day gap in any prescribed CV medication refills, they will be randomized to one of four arms, described in Intervention below. Randomization will be stratified within each of the clinics, and within strata defined by number of other CV medication classes that are prescribed at randomization (1-4), using blocks of 4 patients to ensure balance within clinics over time. Thus, within each clinic and number of other medication stratum, each set of 4 consecutively enrolled subjects will be randomized to the four study arms. Treatments will be initiated immediately upon randomization, in response to the 7-day gap.
- Masking
- None (open label)
- Enrolment
- 9,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Ho, MD, PhD, Principal investigator, University of Colorado, DenverSheana Bull, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973931
- Sponsor's protocol ID
- 18-2779
- Other IDs
- UH3HL144163
- Status last verified
- Mar 2025
- First submitted
- 31 May 2019
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820.
PubMed 18299512Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842.
PubMed 17000940Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007 Jan 10;297(2):177-86. doi: 10.1001/jama.297.2.177.
PubMed 17213401Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, Krumholz HM, Cohen DJ. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation. 2006 Jun 20;113(24):2803-9. doi: 10.1161/CIRCULATIONAHA.106.618066. Epub 2006 Jun 12.
PubMed 16769908Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.
PubMed 21389250Wei L, Wang J, Thompson P, Wong S, Struthers AD, MacDonald TM. Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart. 2002 Sep;88(3):229-33. doi: 10.1136/heart.88.3.229.
PubMed 12181210Wei L, Flynn R, Murray GD, MacDonald TM. Use and adherence to beta-blockers for secondary prevention of myocardial infarction: who is not getting the treatment? Pharmacoepidemiol Drug Saf. 2004 Nov;13(11):761-6. doi: 10.1002/pds.963.
PubMed 15386713Lu CY, Ross-Degnan D, Soumerai SB, Pearson SA. Interventions designed to improve the quality and efficiency of medication use in managed care: a critical review of the literature - 2001-2007. BMC Health Serv Res. 2008 Apr 7;8:75. doi: 10.1186/1472-6963-8-75.
PubMed 18394200Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
PubMed 19102784Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.
PubMed 17502632Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.
PubMed 17101639Peterson PN, Campagna EJ, Maravi M, Allen LA, Bull S, Steiner JF, Havranek EP, Dickinson LM, Masoudi FA. Acculturation and outcomes among patients with heart failure. Circ Heart Fail. 2012 Mar 1;5(2):160-6. doi: 10.1161/CIRCHEARTFAILURE.111.963561. Epub 2012 Jan 13.
PubMed 22247483Gurol-Urganci I, de Jongh T, Vodopivec-Jamsek V, Atun R, Car J. Mobile phone messaging reminders for attendance at healthcare appointments. Cochrane Database Syst Rev. 2013 Dec 5;2013(12):CD007458. doi: 10.1002/14651858.CD007458.pub3.
PubMed 24310741de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.
PubMed 23235644Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007457. doi: 10.1002/14651858.CD007457.pub2.
PubMed 23235643
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
- ClinicalTrials.gov ID
- NCT03973931
- Acronym / sponsor ID
- 18-2779
- Conditions
- Cardiovascular Diseases, Adherence, Medication, Medication Adherence, Diabetes Mellitus, Hypertension, Hyperlipidemias
- Keywords
- cardiovascular disease, telemedicine, medication adherence, behavioral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,501 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study will be a pragmatic, randomized controlled study with four treatment arms. Once patients are identified through pharmacy refill data to have a 7-day gap in any prescribed CV medication refills, they will be randomized to one of four arms, described in Intervention below. Randomization will be stratified within each of the clinics, and within strata defined by number of other CV medication classes that are prescribed at randomization (1-4), using blocks of 4 patients to ensure balance within clinics over time. Thus, within each clinic and number of other medication stratum, each set of 4 consecutively enrolled subjects will be randomized to the four study arms. Treatments will be initiated immediately upon randomization, in response to the 7-day gap.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No 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. |
| Generic Nudge | Experimental | Behavioral: NudgeA 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. |
| Optimized nudge | Experimental | Behavioral: NudgeAn 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. |
| Optimized nudge plus AI Chat Bot | Experimental | Behavioral: NudgeAn 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NudgeInterventions will include a variety of text messages aimed at improving medication adherence. | Behavioural | Generic Nudge, Optimized nudge, Optimized nudge plus AI Chat Bot |
Primary outcome
Medication Adherence
Time frame: 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.
Mean Proportion of Days Covered Relative to Usual Care
Time frame: 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 method was used for the 3 pairwise comparisons, where R is the number of significant stage 1 tests.
3 secondary outcomes
Hospitalization
Time frame: one year
Death
Time frame: one year
Emergency Department Visit
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18299512Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820.
- Background: PubMed 17000940Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842.
- Background: PubMed 17213401Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007 Jan 10;297(2):177-86. doi: 10.1001/jama.297.2.177.
- Background: PubMed 16769908Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, Krumholz HM, Cohen DJ. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation. 2006 Jun 20;113(24):2803-9. doi: 10.1161/CIRCULATIONAHA.106.618066. Epub 2006 Jun 12.
- Background: PubMed 21389250Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.
- Background: PubMed 12181210Wei L, Wang J, Thompson P, Wong S, Struthers AD, MacDonald TM. Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart. 2002 Sep;88(3):229-33. doi: 10.1136/heart.88.3.229.
- Background: PubMed 15386713Wei L, Flynn R, Murray GD, MacDonald TM. Use and adherence to beta-blockers for secondary prevention of myocardial infarction: who is not getting the treatment? Pharmacoepidemiol Drug Saf. 2004 Nov;13(11):761-6. doi: 10.1002/pds.963.
- Background: PubMed 18394200Lu CY, Ross-Degnan D, Soumerai SB, Pearson SA. Interventions designed to improve the quality and efficiency of medication use in managed care: a critical review of the literature - 2001-2007. BMC Health Serv Res. 2008 Apr 7;8:75. doi: 10.1186/1472-6963-8-75.
- Background: PubMed 19102784Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
- Background: PubMed 17502632Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.
- Background: PubMed 17101639Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.
- Background: PubMed 22247483Peterson PN, Campagna EJ, Maravi M, Allen LA, Bull S, Steiner JF, Havranek EP, Dickinson LM, Masoudi FA. Acculturation and outcomes among patients with heart failure. Circ Heart Fail. 2012 Mar 1;5(2):160-6. doi: 10.1161/CIRCHEARTFAILURE.111.963561. Epub 2012 Jan 13.
- NIH Collaboratory Site discussing the Nudge ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ho, MD, PhD principal investigator
University of Colorado, Denver
Sheana Bull, PhD, MPH principal investigator
University of Colorado, Denver
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge in people with Cardiovascular Diseases and Adherence, Medication, run by University of Colorado, Denver at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 12 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973931, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.