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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorCosmos Rx, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Cosmos Rx, Inc

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Sentara Norfolk General Hospital

Collaborator