[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07613216":3,"trial-entities:NCT07613216":109,"trial-summary:NCT07613216":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":34,"secondary_outcomes":39,"sex":49,"minimum_age":50,"maximum_age":28,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":76,"overall_officials":81,"references":82,"see_also_links":108},"NCT07613216","CosmosSentaraILD1","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","NOT_YET_RECRUITING","2027-08","2026-05","2026-05-29","2026-07","Cosmos Rx, Inc","INDUSTRY",false,"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.","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 side effects and substantial costs.\n\nPulmonary hypertension(PH) associated with lung disease is a serious and increasingly recognized complication of chronic parenchymal lung diseases, most notably interstitial lung disease (ILD) and chronic obstructive pulmonary disease. A recent systematic review and meta-analysis found a pooled prevalence of PH of 36% in ILD populations. Clinically, patients present with progressive exertional dyspnea and fatigue that is disproportionate to the severity of their underlying ILD, markedly reduced exercise capacity, worsening hypoxemia, and, in advanced disease, right heart failure. Management of remains challenging; most drugs approved for pulmonary arterial hypertension have demonstrated no benefit or potentially harmful effects in this population. A notable exception is inhaled treprostinil, which has demonstrated improvements in exercise capacity in patients with ILD-associated PH, representing a meaningful but limited advance in an area of substantial unmet therapeutic need.\n\nMedication non-adherence is associated with greater morbidity and mortality across chronic diseases and has been estimated to increase U.S. healthcare costs by over $170 billion annually. For patients with ILD and PH - who carry high treatment burden, significant medication side effects, and complex regimens - adherence represents a particularly critical and modifiable variable.\n\nThe 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. A companion smartphone application delivers dose-deviation reminders to subjects, and a physician dashboard alerts clinicians to adherence trends. This study will generate the first prospective data on FORTISKAP™ performance in an ILD\u002FPH population. Medication adherence is challenging for patients across the spectrum of medical disorders that are treated with chronic use of oral medications. Poor medication adherence can result in increased risk of complications,disease progression, increased healthcare utilization and poor therapeutic outcomes. While these therapies can be effective for certain ILD subtypes, they carry significant risks including cytopenias, nephrotoxicity, weight gain, adrenal suppression,etc and they can be expensive - creating a burden for the patient and the healthcare system.\n\n4.3 Study Design\u002FStatistical Analysis Plan\n\nFifty subjects with a primary diagnosis of ILD, sarcoidosis, and\u002For pulmonary hypertension will be enrolled from the Sentara Pulmonary, Critical Care \\& Sleep Specialists clinic and followed for 270 days (approximately 9 months) while using the FORTISKAP™ device on their primary oral ILD\u002FPH medication. This prospective cohort will be compared to 50 propensity-matched historical controls drawn from the same clinical practice who received usual care without the device. The primary analytic approach is difference-in-differences (DiD), estimating the treatment effect by comparing within-group change over time between the intervention and control arms. Propensity score matching will be performed on clinically relevant baseline covariates including diagnosis (ILD, PH, or both), disease severity indices, age, sex, baseline functional status, and relevant comorbidities.\n\nDifference-in-Differences: 6-Minute Walk Test (6MWT)\n\nThe 6MWT distance (meters) will be assessed at baseline and Day 270. The DiD estimator will be computed as:\n\nDiD = (FORTISKAP™ post - FORTISKAP™ pre) - (Control post - Control pre) This will be implemented using a linear mixed-effects model with fixed effects for time (baseline vs. end of study), group (FORTISKAP™ vs. control), and their interaction term (group × time), which directly yields the DiD estimate. Subject will be included as a random effect to account for within-person correlation. The interaction coefficient and its 95% confidence interval will be the primary reported effect estimate. A minimally clinically important difference (MCID) of 30 meters will be used as a reference threshold for clinical significance.\n\nDifference-in-Differences: Pulmonary Function Tests (FVC and DLCO)\n\nFVC (expressed as percent predicted) and DLCO (expressed as percent predicted) will each be analyzed using the same linear mixed-effects DiD framework described above, with separate models for each outcome. 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%8 and DLCO decline of ≥15%9 will be used as reference thresholds for clinical significance.\n\nDifference-in-Differences: Echocardiographic Parameters (TRV\u002FsPAP and RV Size)\n\nTRV (m\u002Fs) and estimated sPAP (mmHg), along with a qualitative or quantitative measure of RV size (e.g., RV basal diameter in cm or a semi-quantitative grading), will each be modeled using the same DiD linear mixed-effects framework as FVC and DLCO.\n\nObjective vs. Self-Reported Adherence\n\nAgreement between objective and self-reported adherence will be evaluated by cross-classifying subjects according to two binary adherence definitions:\n\nObjective adherence (FORTISKAP™): Adherent if ≥80% of prescribed doses recorded via electronic bottle-opening monitoring.\n\nSelf-reported adherence (ARMS): Adherent if ARMS score ≤16\n\nThe primary measure of agreement will be Cohen's kappa (κ). Sensitivity, specificity, and positive and negative predictive values will be calculated treating FORTISKAP™ electronic monitoring as the reference standard, given its objective nature. McNemar's test will be used to assess whether discordance between the two methods is asymmetric - specifically, to evaluate the expected directional hypothesis that self-report systematically overestimates adherence relative to electronic monitoring.\n\nLongitudinal ARMS Trends (Day 7, Day 90, Day 270)\n\nARMS scores collected at three timepoints (Day 7, Day 90, and Day 270) in the FORTISKAP™ group will be analyzed using a linear mixed-effects model with time as a fixed effect and subject as a random intercept, to characterize the trajectory of self-reported adherence over the study period. If the ARMS is also collected in controls, a group × time interaction term will be added to compare trajectories between arms.\n\nPairwise contrasts between timepoints (Day 7 vs. Day 90, Day 90 vs. Day 270, Day 7 vs. Day 270) will be tested with appropriate correction for multiple comparisons (e.g., Bonferroni or Tukey). Exploratory analyses will examine associations between ARMS trajectory and baseline demographic variables and social determinants of health (SDOH) using multivariable regression, with ARMS score change from Day 7 to Day 270 as the dependent variable.\n\nSample size and power:\n\nWith 50 subjects per group, this study is powered as a pilot\u002Ffeasibility investigation. Formal power calculations for the DiD analyses should be conducted using estimates of within-group change and variability from the published literature in ILD and PH populations; these should be reported alongside observed effect sizes to inform the design of subsequent confirmatory trials.\n\nMultiple comparisons: Given the preliminary and exploratory nature of this study, p-value thresholds will be set at α = 0.05 for primary DiD outcomes, with secondary and exploratory analyses interpreted with appropriate caution. No formal multiplicity correction is proposed across the full set of outcomes at this stage, but this should be revisited in the confirmatory protocol.",[18,19,20,21],"Idiopathic Pulmonary Fibrosis (IPF)","Sarcoidosis Lung","Pulmonary Hypertension","Usual Interstitial Pneumonia",[23,24,25,26],"medication adherence","Interstitial Lung Disease","nintedanib","pirfenidone","OBSERVATIONAL",null,[],{"count":31,"type":32},100,"ESTIMATED",[],[35],{"measure":36,"description":37,"timeFrame":38},"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)\n\nA minimally clinically important difference (MCID) of 30 meters will be used as a reference threshold for clinical significance.","9 months",[40,43,46],{"measure":41,"description":42,"timeFrame":38},"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.",{"measure":44,"description":45,"timeFrame":38},"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:\n\nObjective adherence (FORTISKAP™): Adherent if ≥80% of prescribed doses recorded via electronic bottle-opening monitoring.\n\nSelf-reported adherence (ARMS): Adherent if ARMS score ≤16",{"measure":47,"description":48,"timeFrame":38},"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.","ALL","21 Years",{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. 21 years of age or older at time of enrollment\n2. Primary diagnosis of interstitial lung disease (including sarcoidosis) AND\u002FOR pulmonary hypertension\n3. Currently managing their oral medications independently (i.e., without requiring caregiver administration)\n4. 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\n5. 6-Minute Walk Test (6MWT) scheduled within the next 30 days or performed within the past 30 days\n6. For ILD subjects: FVC and\u002For DLCO scheduled within the next 30 days or performed within the past 90 days\n7. For PH subjects: Cardiac echocardiography scheduled within the next 30 days or performed within the past 90 days\n8. Daily access to a smartphone compatible with the FORTISKAP™ companion application\n9. Proficient in English\n\nExclusion Criteria:\n\nFailure to meet any one of the above inclusion criteria",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"Pulmonary Disease Clinic, Sentara Norfolk Hospital","Norfolk","Virginia","23507","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Matthew Bernens, MD","CONTACT","757-388-6115","mxbernen@sentara.com",{"name":67,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},36.84681,-76.28522,[77],{"name":78,"role":68,"phone":79,"email":80},"Abraham N Morse, MD,MBA","5082437396","nick@cosmosrx.com",[],[83,87,90,93,96,99,102,105],{"pmid":84,"type":85,"citation":86},"19911444","BACKGROUND","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\u002Fj.1524-4733.2008.00400.x.",{"pmid":88,"type":85,"citation":89},"38632477","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\u002Fs41598-024-59649-5.",{"pmid":91,"type":85,"citation":92},"21940789","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\u002Frccm.201105-0840OC. Epub 2011 Sep 22.",{"pmid":94,"type":85,"citation":95},"27592691","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\u002Fjep.12629. Epub 2016 Sep 4.",{"pmid":97,"type":85,"citation":98},"34380627","Simon ST, Kini V, Levy AE, Ho PM. Medication adherence in cardiovascular medicine. BMJ. 2021 Aug 11;374:n1493. doi: 10.1136\u002Fbmj.n1493.",{"pmid":100,"type":85,"citation":101},"20131023","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\u002Fs11606-010-1253-9. Epub 2010 Feb 4.",{"pmid":103,"type":85,"citation":104},"37591300","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\u002FS2213-2600(23)00259-X. Epub 2023 Aug 14.",{"pmid":106,"type":85,"citation":107},"38821182","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\u002Fj.chest.2024.04.025. Epub 2024 May 29.",[],{"nct_id":4,"conditions":110,"biomarkers":113},[111,24,20,112,21],"Idiopathic Pulmonary Fibrosis","Sarcoidosis",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an observational study comparing participants using the FORTISKAP™ device to those receiving usual care. It plans to enroll 100 participants.","completed","FORTISKAP™ for Interstitial Lung Disease and Pulmonary Hypertension","This study is looking at whether using the FORTISKAP™ smart medication cap helps people with serious lung diseases like idiopathic pulmonary fibrosis (IPF), sarcoidosis, and pulmonary hypertension take their oral medications more consistently. The FORTISKAP™ cap tracks when you open your medication bottle and sends reminders. Researchers want to see if using this device leads to better health outcomes compared to standard care without the device. You would continue your usual medications, tests, and doctor visits. If you join, you'll use a modified medication bottle with the FORTISKAP™ cap for nine months. The study will measure your walking ability (6-minute walk test) at the end of this period to see if there's an improvement. This study is currently unclear on its recruitment status, and aims to enroll 100 participants aged 21 or older who manage their own oral medications for these conditions.","The primary endpoint, the 6-minute walk test, is measured at 9 months.",142,"Participants will use a modified medication bottle with the FORTISKAP™ cap for nine months. No changes to prescribed medications, testing, or clinical visits beyond routine care are required.","Not stated in the trial record.",[],"v2"]