Who is eligible for clinical trial NCT07613216?

Participants must meet protocol criteria for Idiopathic Pulmonary Fibrosis (IPF). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07613216 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-26

A Comparison of a Medication Adherence Platform (FORTISKAP™) vs. Usual Care in Subjects on Oral Medications for the Treatment of Interstitial Lung Disease, Sarcoid and Pulmonary Hypertension (NCT07613216)

🟡 Not Yet Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Cosmos Rx, Inc

🩺 Plain-English Summary (8th-Grade Level)

This study will evaluate whether participants with serious lung diseases such as idiopathic pulmonary fibrosis, sarcoidosis, and pulmonary hypertension who use the FORTISKAP™ smart medication cap - a bottle-top device that tracks prescription bottle openings and sends dose reminders to participants and their care team - take their medications more consistently and experience better health outcomes compared to similar participants receiving standard care without the device. Participation requires no changes to prescribed medications, testing or clinical visits beyond what is already part of routine care; participants use a modified medication bottle equipped with the FORTISKAP™ cap for nine months.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (1 items).

Location: Pulmonary Disease Clinic, Sentara Norfolk Hospital — Norfolk, Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

21 years of age or older at time of enrollment
Primary diagnosis of interstitial lung disease (including sarcoidosis) AND/OR pulmonary hypertension
Currently managing their oral medications independently (i.e., without requiring caregiver administration)
At least one oral medication with a primary indication for treatment of ILD or PH already in use, or planned for initiation with insurance approval secured, at the time of enrollment
6-Minute Walk Test (6MWT) scheduled within the next 30 days or performed within the past 30 days
For ILD subjects: FVC and/or DLCO scheduled within the next 30 days or performed within the past 90 days
For PH subjects: Cardiac echocardiography scheduled within the next 30 days or performed within the past 90 days
Daily access to a smartphone compatible with the FORTISKAP™ companion application
Proficient in English

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Failure to meet any one of the above inclusion criteria

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Pulmonary Disease Clinic, Sentara Norfolk Hospital — Norfolk, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗