Trials / Completed
CompletedNCT03973931
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9,501 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Cardiovascular Diseases
- Adherence, Medication
- Medication Adherence
- Diabetes Mellitus
- Hypertension
- Hyperlipidemias
- Coronary Artery Disease
- Atrial Fibrillation
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Nudge | Interventions will include a variety of text messages aimed at improving medication adherence. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2023-05-25
- Completion
- 2023-11-19
- First posted
- 2019-06-04
- Last updated
- 2025-04-02
- Results posted
- 2025-04-02
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03973931. Inclusion in this directory is not an endorsement.