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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The FORTISKAP™ platform (Cosmos Rx, Inc.) is a bottle-top electro-optical device that records time-stamped prescription bottle openings and estimates pill counts using proprietary image processing algorithms, providing an objective measure of adherence."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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/or DLCO scheduled within the next 30 days or performed within the past 90 days 7. For PH subjects: Cardiac echocardiography scheduled within the next 30 days or performed within the past 90 days 8. Daily access to a smartphone compatible with the FORTISKAP™ companion application 9. Proficient in English Exclusion Criteria: Failure to meet any one of the above inclusion criteria

Study sites (1)

VA