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

NCT07712614 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-17

No results posted yet for this study

Summary

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.

Conditions

  • GERD (Gastroesophageal Reflux Disease)

Interventions

DEVICE

Fortiskap

The Fortiskap bottle-top medication monitor is fingerpring access controlled, records bottle opening and estimates the number of pills left in the bottle after each event.

Sponsors & Collaborators

  • Cosmos Rx, Inc

    lead INDUSTRY

Principal Investigators

  • Abraham N Morse, MD, MBA · Cosmos Rx, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-03-01
Completion
2027-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712614 on ClinicalTrials.gov