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.
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
None
People with intersitial lung disease, sarcoidosis and/or pulmonary hypertension
Cohort
Prospective
Not listed
6 minute walk test
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.
Pulmonary Function Test (FVC)
FVC (expressed as percent predicted) will each be analyzed using the same linear mixed-effects DiD framework described above. Given the known correlation between FVC and DLCO in ILD, a sensitivity analysis using a bivariate mixed-effects model may be considered to jointly model both outcomes and account for their within-subject correlation. An FVC decline of ≥10% will be used as reference thresholds for clinical significance.
Objective vs. Self-Reported Adherence
Agreement between objective and self-reported adherence will be evaluated by cross-classifying subjects according to two binary adherence definitions: Objective adherence (FORTISKAP™): Adherent if ≥80% of prescribed doses recorded via electronic bottle-opening monitoring. Self-reported adherence (ARMS): Adherent if ARMS score ≤16
DLCO
DLCO (expressed as percent predicted) will each be analyzed using a linear mixed-effects DiD framework described above. A DLCO decline of ≥15% will be used as reference thresholds for clinical significance.
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Cosmos Rx, Inc
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Sentara Norfolk General Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
