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
Cosmos Rx, Inc
Summary
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.
Description
Interstitial Lung Disease (ILD) is a group of conditions that cause progressive inflammation and often irreversible scarring of lung tissue. This fibrotic process disrupts oxygen and carbon dioxide exchange, leading to symptoms including dyspnea, cough, wheezing, chest discomfort, and hemoptysis. Patients with ILD experience substantial functional impairment; hospitalizations for respiratory failure carry a one-year mortality exceeding 50%. Long-term management frequently involves glucocorticoids, immunosuppressants (e.g., azathioprine), and antifibrotic agents - all of which carry significant…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 21 years of age or older at time of enrollment 2. Primary diagnosis of interstitial lung disease (including sarcoidosis) AND/OR pulmonary hypertension 3. Currently managing their oral medications independently (i.e., without requiring caregiver administration) 4. 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 5. 6-Minute Walk Test (6MWT) scheduled within the next 30 days or performed within the past 30 days 6. For ILD subjects: FVC and/…
Location
- Pulmonary Disease Clinic, Sentara Norfolk HospitalNorfolk, Virginia