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

NCT07613216 | Not Yet Recruiting

• 2 other identifiers: CosmosSentaraILD1U54HL143541
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

medication adherence; Interstitial Lung Disease; nintedanib; pirfenidone

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (3)

• Pulmonary Function Test (FVC)

  9 months

• Objective vs. Self-Reported Adherence

  9 months

• DLCO

  9 months

Study Arms (2)

Fortiskap Group

Prospective Cohort equipped with medication adherence monitoring device

Historical Controls

Historical Control group (retrospective cohort)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with intersitial lung disease, sarcoidosis and/or pulmonary hypertension

You may qualify if:

• 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
• Minute Walk Test (6MWT) scheduled within the next 30 days or performed within the past 30 days
• For ILD subjects: FVC and/or DLCO scheduled within the next 30 days or performed within the past 90 days
• For PH subjects: Cardiac echocardiography scheduled within the next 30 days or performed within the past 90 days
• Daily access to a smartphone compatible with the FORTISKAP™ companion application
• Proficient in English

Sponsors & Collaborators

• Cosmos Rx, Inc: lead
• Sentara Norfolk General Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Pulmonary Disease Clinic, Sentara Norfolk Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (8)

• Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.

  PMID: 19911444 BACKGROUND

• Lee H, Kim SY, Park YS, Choi SM, Lee JH, Park J. Prognostic implication of 1-year decline in diffusing capacity in newly diagnosed idiopathic pulmonary fibrosis. Sci Rep. 2024 Apr 17;14(1):8857. doi: 10.1038/s41598-024-59649-5.

  PMID: 38632477 BACKGROUND

• du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, King TE Jr, Lancaster L, Noble PW, Sahn SA, Thomeer M, Valeyre D, Wells AU. Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1382-9. doi: 10.1164/rccm.201105-0840OC. Epub 2011 Sep 22.

  PMID: 21940789 BACKGROUND

• Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.

  PMID: 27592691 BACKGROUND

• Simon ST, Kini V, Levy AE, Ho PM. Medication adherence in cardiovascular medicine. BMJ. 2021 Aug 11;374:n1493. doi: 10.1136/bmj.n1493.

  PMID: 34380627 BACKGROUND

• Fischer MA, Stedman MR, Lii J, Vogeli C, Shrank WH, Brookhart MA, Weissman JS. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010 Apr;25(4):284-90. doi: 10.1007/s11606-010-1253-9. Epub 2010 Feb 4.

  PMID: 20131023 BACKGROUND

• Olsson KM, Corte TJ, Kamp JC, Montani D, Nathan SD, Neubert L, Price LC, Kiely DG. Pulmonary hypertension associated with lung disease: new insights into pathomechanisms, diagnosis, and management. Lancet Respir Med. 2023 Sep;11(9):820-835. doi: 10.1016/S2213-2600(23)00259-X. Epub 2023 Aug 14.

  PMID: 37591300 BACKGROUND

• Ang HL, Schulte M, Chan RK, Tan HH, Harrison A, Ryerson CJ, Khor YH. Pulmonary Hypertension in Interstitial Lung Disease: A Systematic Review and Meta-Analysis. Chest. 2024 Oct;166(4):778-792. doi: 10.1016/j.chest.2024.04.025. Epub 2024 May 29.

  PMID: 38821182 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Sarcoidosis, Pulmonary; Hypertension, Pulmonary; Medication Adherence; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Abraham N Morse, MD,MBA

CONTACT

5082437396; nick@cosmosrx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)