FORTISKAP™ for Interstitial Lung Disease and Pulmonary Hypertension

This study is looking at whether using the FORTISKAP™ smart medication cap helps people with serious lung diseases like idiopathic pulmonary fibrosis (IPF), sarcoidosis, and pulmonary hypertension take their oral medications more consistently. The FORTISKAP™ cap tracks when you open your medication bottle and sends reminders. Researchers want to see if using this device leads to better health outcomes compared to standard care without the device. You would continue your usual medications, tests, and doctor visits. If you join, you'll use a modified medication bottle with the FORTISKAP™ cap for nine months. The study will measure your walking ability (6-minute walk test) at the end of this period to see if there's an improvement. This study is currently unclear on its recruitment status, and aims to enroll 100 participants aged 21 or older who manage their own oral medications for these conditions.

Study design
This is an observational study comparing participants using the FORTISKAP™ device to those receiving usual care. It plans to enroll 100 participants.
What's involved
Participants will use a modified medication bottle with the FORTISKAP™ cap for nine months. No changes to prescribed medications, testing, or clinical visits beyond routine care are required.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, the 6-minute walk test, is measured at 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07613216

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

Not Yet Recruiting
Not specifiedAges 21+Observational
Cosmos Rx, Inc
~100 participants
Updated 2026-05-29 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6 minute walk test
Measured over 9 months
Idiopathic Pulmonary Fibrosis (IPF)
Sarcoidosis Lung
Pulmonary Hypertension
Usual Interstitial Pneumonia

NCT07613216

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Pulmonary Disease Clinic, Sentara Norfolk Hospital

    Norfolk, Virginiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

  • 6 minute walk test9 months

    The 6MWT will be assessed at baseline and Day 270. The DiD estimator will be computed as: DiD = (FORTISKAP™ post - FORTISKAP™ pre) - (Control post - Control pre) A minimally clinically important difference (MCID) of 30 meters will be used as a reference threshold for clinical significance.