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.
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
At a glance
Conditions
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.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.