A Comparison of Cosmos Rx Medication Adherence Platform vs. Pharmacy Fill Adherence Measures

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Conditions studied: GERD (Gastroesophageal Reflux Disease)

In brief

Medication non-adherence is associated with greater morbidity and mortality in chronic disease, and has been estimated to increase healthcare costs by over $170 billion annually in the United States.1 Medication adherence is challenging for patients across the spectrum of medical disorders that are treated with long-term use of oral medications. Poor medication adherence can result in increased risk of complications, disease progression, increased healthcare utilization and poor therapeutic outcomes.2 Adherence is typically tracked using measures based on pharmacy fill data such as the medication possession ratio (MPR) and/or proportion of days covered (PDC).3 Although MPR and PDC are associated with a higher likelihood of using medication as prescribed at the population level, when compared to direct assessments or patient reports, they are not accurate enough for making individual management decisions and likely to underestimate non-adherence.4 However, real-time documentation methods using direct video observation are expensive and cumbersome for patients and providers. Gastroesophageal reflux disease (GERD) is among the most prevalent gastrointestinal conditions in the United States, affecting an estimated 20-30% of the adult population.5 Proton pump inhibitors (PPIs) are the cornerstone of pharmacologic management for GERD forming the standard of care for erosive esophagitis, Barrett's esophagus, and symptomatic non-erosive reflux disease.6 Despite their established efficacy, suboptimal medication adherence remains a significant clinical barrier: estimates of PPI adherence in real-world populations range from 50-70% at one year7, with non-adherence associated with symptom recurrence, mucosal injury, and increased healthcare utilization.8 FORTISKAP™ (Cosmos Rx, Inc.) is a digital adherence monitoring device consisting of a sensor-embedded cap that attaches to standard prescription medication bottles. The device records the date and time of each bottle opening event and transmits this data wirelessly to a paired smartphone application, which generates adherence metrics and patient-facing reminders. Prescribers may access aggregated adherence data through a connected provider portal. The goal of this study is to demonstrate that the Fortiskap™ prescription bottle-top, medication adherence device results in a higher detection rate of medication non-adherence compared to pharmacy fill-data assessment and/or compared to ARMS adherence self-assessment.

Key facts

Study ID

NCT07712614

Run by

Cosmos Rx, Inc

People needed

50

Starts

2026-09-01

Expected to finish

2027-04-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 21 years at time of enrollment Confirmed diagnosis of GERD and/or erosive esophagitis documented in the Epic medical record (ICD-10 code K21.0 or K21.9) Currently prescribed a once-daily oral PPI (omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, or dexlansoprazole) for a minimum of 30 days prior to enrollment Willing and able to fill PPI prescription exclusively at TidalHealth Community Pharmacy for the 90-day study period Owns a smartphone (iOS or Android) capable of running the FORTISKAP™ companion application Able to participate in the study enrollment and ongoing requirements in English.

You may not qualify if…

• Current diagnosis of active esophageal malignancy, gastric malignancy, or other upper gastrointestinal malignancy requiring active systemic treatment Cognitive impairment, dementia, or other neurological condition that, in the judgment of the Site PI, would prevent proper use of the FORTISKAP™ device or completion of self-report questionnaires Institutionalized subjects (nursing home, assisted living, correctional facility) or subjects whose medications are managed by a caregiver who would need to operate the device on their behalf Life expectancy < 6 months in the judgment of the treating physician

Where it is running

• Tidal Health — Salisbury, Maryland, United States

Full record on ClinicalTrials.gov

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