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

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Cosmos Rx, Inc
Study ID
NCT07613216
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)
  • Pulmonary Hypertension
  • Sarcoidosis Lung
  • Usual Interstitial Pneumonia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Fortiskap Group
    Prospective Cohort equipped with medication adherence monitoring device
  • Arm: Historical Controls
    Historical Control group (retrospective cohort)

Primary Outcome Measure

6 minute walk test [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pulmonary Disease Clinic, Sentara Norfolk HospitalNorfolkVirginia23507
Matthew Bernens, MD
[email protected]
757-388-6115
Matthew Bernens, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Norfolk, VA

By research site
Pulmonary Disease Clinic, Sentara Norfolk Hospital· Norfolk, VA

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