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

NCT07712614 | Not Yet Recruiting

• 1 other identifier: THPPI2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

proton pump inhibitor, GERD, medication adherence

Outcome Measures

Primary Outcomes (2)

• Fortiskap vs. PDC adherence

  Comparison of medication adherence between Fortiskap™ tracking of prescription bottle opening and pharmacy fill data: The study measure is defined as the proportion of study days with at least one recorded medication removal event ("Fortiskap adherence rate") compared with the Proportion of Days Covered(PDC): the number of days during which pharmacy fill records demonstrate medication available divided by the number of study days. The primary comparison is a within subject paired analysis of continuous variables.

  90 days

• Fortiskap vs. ARMS adherence comparison

  Comparison of medication adherence between Fortiskap™ tracking of prescription bottle opening and a validated adherence self-reporting tool: The study measure is defined as the proportion of study days with at least one recorded medication removal event ("Fortiskap adherence rate") compared with vs. Adherence to Refills and Medications Scale (ARMS) adherence self-reporting instrument.9 The primary comparison is a within subject paired analysis of the industry-standard dichotomous outcomes of 80% for daily medication consumption and \>=16 for the ARMS.

  90 days

Study Arms (1)

Fortiskap group

EXPERIMENTAL

subjects using the Fortiskap device to monitor medication adherence

Device: Fortiskap

Interventions

Fortiskap DEVICE

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.

Fortiskap group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cosmos Rx, Inc: lead

Study Sites (1)

Tidal Health

Salisbury, Maryland, 21801, United States

Location

Related Publications (7)

• Boghossian TA, Rashid FJ, Thompson W, Welch V, Moayyedi P, Rojas-Fernandez C, Pottie K, Farrell B. Deprescribing versus continuation of chronic proton pump inhibitor use in adults. Cochrane Database Syst Rev. 2017 Mar 16;3(3):CD011969. doi: 10.1002/14651858.CD011969.pub2.

  PMID: 28301676 BACKGROUND

• Maret-Ouda J, Markar SR, Lagergren J. Gastroesophageal Reflux Disease: A Review. JAMA. 2020 Dec 22;324(24):2536-2547. doi: 10.1001/jama.2020.21360.

  PMID: 33351048 BACKGROUND

• Fass R. Gastroesophageal Reflux Disease. N Engl J Med. 2022 Sep 29;387(13):1207-1216. doi: 10.1056/NEJMcp2114026. No abstract available.

  PMID: 36170502 BACKGROUND

• Wickham ME, McGrail KM, Law MR, Cragg A, Hohl CM. Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data. Br J Clin Pharmacol. 2024 May;90(5):1240-1246. doi: 10.1111/bcp.16014. Epub 2024 Feb 6.

  PMID: 38320955 BACKGROUND

• Alhazami M, Pontinha VM, Patterson JA, Holdford DA. Medication Adherence Trajectories: A Systematic Literature Review. J Manag Care Spec Pharm. 2020 Sep;26(9):1138-1152. doi: 10.18553/jmcp.2020.26.9.1138.

  PMID: 32857646 BACKGROUND

• Simon ST, Kini V, Levy AE, Ho PM. Medication adherence in cardiovascular medicine. BMJ. 2021 Aug 11;374:n1493. doi: 10.1136/bmj.n1493.

  PMID: 34380627 BACKGROUND

• Fischer MA, Stedman MR, Lii J, Vogeli C, Shrank WH, Brookhart MA, Weissman JS. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010 Apr;25(4):284-90. doi: 10.1007/s11606-010-1253-9. Epub 2010 Feb 4.

  PMID: 20131023 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Medication Adherence

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Abraham N Morse, MD, MBA

  Cosmos Rx, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abraham N Morse, MD, MBA

CONTACT

3027946587; nick@cosmosrx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (1)