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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Hypertension; Coronary Artery Disease; Atrial Fibrillation; Adherence, Medication; Medication Adherence; Cardiovascular Diseases; Hyperlipidemias

• Registration Number: NCT03973931
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Study Start: 2019-07-01
• Primary Completion: 2023-05-25
• Study Completion: 2023-11-19
• Results First Submitted: 2024-12-06
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Results First Posted: 2025-04-02
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9501

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Adherence	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	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.

Secondary Outcome Measures

Name	Time	Method
Hospitalization	one year	estimated probability of hospitalization at one year
Death	one year	estimated probability of death at one year
Emergency Department Visit	one year	estimated probability of emergency department visit at one year

Trial Locations

Locations (4)

UCHealth; 🇺🇸 Aurora, Colorado, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

VA Eastern Colorado Health Care System; 🇺🇸 Aurora, Colorado, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States