Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
2 other identifiers
interventional
9,501
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Jul 2019
Longer than P75 for not_applicable cardiovascular-diseases
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2023
CompletedResults Posted
Study results publicly available
April 2, 2025
CompletedApril 2, 2025
March 1, 2025
3.9 years
May 31, 2019
December 6, 2024
March 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
12 months
Secondary Outcomes (3)
Hospitalization
one year
Death
one year
Emergency Department Visit
one year
Study Arms (4)
Usual Care
NO INTERVENTIONThis 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
EXPERIMENTALA 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
EXPERIMENTALAn 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
EXPERIMENTALAn 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.
Interventions
Interventions will include a variety of text messages aimed at improving medication adherence.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCHealth
Aurora, Colorado, 80045, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
VA Eastern Colorado Health Care System
Aurora, Colorado, 80045, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Related Publications (18)
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.
PMID: 18299512BACKGROUNDHo 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.
PMID: 17000940BACKGROUNDRasmussen 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.
PMID: 17213401BACKGROUNDSpertus 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.
PMID: 16769908BACKGROUNDBrown 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.
PMID: 21389250BACKGROUNDWei 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.
PMID: 12181210BACKGROUNDWei 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.
PMID: 15386713BACKGROUNDLu 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.
PMID: 18394200BACKGROUNDVolpp 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.
PMID: 19102784BACKGROUNDMurray 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.
PMID: 17502632BACKGROUNDLee 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.
PMID: 17101639BACKGROUNDPeterson 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.
PMID: 22247483BACKGROUNDGurol-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.
PMID: 24310741BACKGROUNDde 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.
PMID: 23235644BACKGROUNDVodopivec-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.
PMID: 23235643BACKGROUNDHo PM, Glorioso TJ, Allen LA, Blankenhorn R, Glasgow RE, Grunwald GK, Khanna A, Magid DJ, Marrs JC, Novins-Montague S, Orlando S, Peterson P, Plomondon ME, Sandy LM, Saseen JJ, Trinkley KE, Vaughn S, Waughtal J, Bull S. Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial. JAMA. 2025 Jan 7;333(1):49-59. doi: 10.1001/jama.2024.21739.
PMID: 39621340DERIVEDGlasgow RE, Knoepke CE, Magid D, Grunwald GK, Glorioso TJ, Waughtal J, Marrs JC, Bull S, Ho PM. The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial. Trials. 2021 Aug 11;22(1):528. doi: 10.1186/s13063-021-05453-9.
PMID: 34380527DERIVEDLuong P, Glorioso TJ, Grunwald GK, Peterson P, Allen LA, Khanna A, Waughtal J, Sandy L, Ho PM, Bull S. Text Message Medication Adherence Reminders Automated and Delivered at Scale Across Two Institutions: Testing the Nudge System: Pilot Study. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007015. doi: 10.1161/CIRCOUTCOMES.120.007015. Epub 2021 May 17.
PMID: 33993727DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Ho
- Organization
- University of Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Ho, MD, PhD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Sheana Bull, PhD, MPH
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 4, 2019
Study Start
July 1, 2019
Primary Completion
May 25, 2023
Study Completion
November 19, 2023
Last Updated
April 2, 2025
Results First Posted
April 2, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be shared in a timely manner, as requested.
- 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.
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.