[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St. Lawrence Health System\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100609631","teleconsultation-approach-to-ctd-ild-care-delivery-in-rural-underserved-communities-trust-initiative-100609631",false,"NCT07217093","Teleconsultation Approach to CTD-ILD Care Delivery in Rural UnderServed CommuniTies (TRUST Initiative)","Inclusion Criteria:\n\n1. Age: Adults aged 18 years or older.\n2. Diagnosis and Stable Condition:\n\n   * Confirmed diagnosis of connective tissue disease-associated interstitial lung disease (CTD-ILD) by a physician based on clinical, radiographic, and\u002For pathological criteria. CTDs may include scleroderma, systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, Sjogren's disease (primary or secondary), inflammatory myopathy including but not limited to dermatomyositis and polymyositis, or any overlap syndrome including one or more of these diseases.\n   * Diagnosis of CTD-ILD established at least one year prior to enrollment\n3. Residence:\n\n   * Full time resident (at least six months per year) of one of the seven counties of the North Country region of New York (St. Lawrence, Franklin, Jefferson, Lewis, Hamilton, Clinton, Essex)\n4. Active Care Relationship:\n\n   * Documented diagnosis of CTD-ILD via any of the following:\n\n     o SLH-affiliated clinician\n\n     o Historical records\n     * Determination by PI\n   * Or an active SLH medical record (≥1 clinical encounter, test, or treatment in past 24 months)\n5. Pulmonary Function Testing and safety labs:\n\n   * Ability and willingness to perform pulmonary function and safety lab tests at local facilities as required by the study protocol.\n   * Most recent PFT within 24 months prior to baseline\n6. Consent:\n\n   * Provide written informed consent to participate in the study, including consent for data collection and telehealth consultations.\n\n8\\. Contraception\n\n\\- Female patients of child-bearing potential (FOCBP) must use at least one highly effective method of contraception between weeks 0 and 48 of the study (complete abstinence, estrogen+progesterone oral contraceptive pill (OCP), progestin-only pill (POP), estrogen+progesterone patch, vaginal ring, Nexplanon, DepoProvera, IUD, bilateral tubal ligation, male partner vasectomy completed at least six months prior to Day 0).\n\nThese inclusion criteria ensure that participants are appropriately diagnosed and can engage fully with the teleconsultation-based care model while addressing the program's focus on improving access for rural and other under-resourced populations.\n\nExclusion Criteria:\n\n1\\. Severe Cognitive or Mental Health Impairment:\n\n* Individuals with severe cognitive dysfunction or mental health conditions that, in the judgment of the PI, would interfere with the ability to provide informed consent or participate in teleconsultation sessions.\n\n  2\\. Life Expectancy \\\u003C 6 Months:\n* Participants with a life expectancy of less than six months due to any cause, as determined by the PI.\n\n  3\\. Other Severe Pulmonary Diseases:\n* Individuals with other severe pulmonary conditions determined by PI with input from Sub-Is (e.g., chronic obstructive pulmonary disease \\[COPD\\], pulmonary fibrosis unrelated to CTD-ILD, or active lung cancer) that may confound the assessment of CTD-ILD progression.\n\n  4\\. Inability to Perform Pulmonary Function Tests:\n* Participants who are unable to perform or complete the required pulmonary function tests because of physical limitations (e.g., significant respiratory distress or severe disability) or non-compliance.\n\n  5\\. Active Participation in another Clinical Trial:\n* Individuals currently participating in another interventional clinical trial for CTD-ILD or other chronic lung diseases that could interfere with the study outcomes.\n\n  6\\. Significant Non-Compliance Risk:\n* Participants who, in the judgment of the PI, are unlikely to comply with the study protocol or follow-up requirements (e.g., inability to attend teleconsultations, failure to complete pulmonary function tests, or non-adherence to study treatment regimen).\n\n  7\\. Current ILD Treatment:\n* Participants who are currently receiving treatment by an ILD specialist at an ILD center at an academic medical center are not eligible to participate in this study.\n\n  8\\. Pregnancy or Breastfeeding:\n* Pregnant or breastfeeding women.\n\nThese exclusion criteria are designed to ensure participant safety, minimize confounding factors, and ensure that participants are able to fully engage in the teleconsultation model and comply with study protocols.","ALL","18 Years",{"count":18,"type":19},10,"ESTIMATED","OBSERVATIONAL","Connective tissue disease-associated interstitial lung disease (CTD-ILD) is a rare and complex condition that affects some individuals with autoimmune disorders such as rheumatoid arthritis (RA). It can lead to inflammation and progressive scarring of the lungs, significantly affecting quality of life and overall prognosis.1 Current clinical guidelines recommend that patients with CTD-ILD receive care at specialized academic medical centers with multi-disciplinary teams experienced in managing interstitial lung disease (ILD).2 These centers, however, are often located in urban areas, making access particularly challenging for patients living in rural and underserved regions. In rural, medically underserved areas, the nearest ILD centers can be three or more hours away, posing substantial barriers to timely, consistent, and expert care. These logistical constraints make it difficult for patients residing in rural areas to access the high-quality, specialized care required to manage CTD-ILD effectively.\n\nThe Teleconsultation Approach to CTD-ILD Care Delivery in Rural Underserved Communities (TRUST Initiative) it looking to address this gap in access to specialized care. The TRUST Initiative aims to evaluate whether integrating teleconsultation into a personalized, multidisciplinary care model, through regular, structured teleconsultation visits, can enhance the quality and coordination of treatment for patients and potentially other rural underserved patient populations. This model utilizes a regional rheumatologist, a regional pulmonologist and, an interstitial lung disease (ILD) specialist at the Mayo Clinic in Rochester, Minnesota.\n\nThis model seeks to overcome the geographic and logistical challenges that prevent patients from accessing specialty care. It also offers a replicable care model for managing other complex chronic diseases in underserved rural communities by leveraging collaborative care, virtual health technology, and structured communication workflows. The study will not only track clinical outcomes such as pulmonary function but also evaluate patient satisfaction, highlighting both the effectiveness and acceptability of this care model.\n\nBy addressing disparities in access to specialty care, the TRUST Initiative aims to inform future healthcare delivery strategies for rare and complex diseases in rural and underserved settings nationwide.",[23,24,25],"Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease in Patients With Rheumatoid Arthritis","Interstitial Lung Disease Due to Systemic Disease","NOT_YET_RECRUITING","2025-10-13",{"date":29,"type":30},"2025-10-15","ACTUAL",{"date":32,"type":19},"2025-11",{"date":34,"type":19},"2026-12",{"name":36,"class":37},"St. Lawrence Health System","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":38},"100595572","comparative-effectiveness-of-primary-care-providers-trained-in-rheumatoid-arthritis-management-versus-rheumatologist-care-a-randomized-controlled-trial-100595572","NCT07034196","Comparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial","TRAIN","Inclusion Criteria:\n\n* Fulfillment of the 2010 ACR\u002FEULAR classification criteria for rheumatoid arthritis Using these criteria, a classification as \"definite RA\" is based upon the presence of synovitis in at least one joint, the absence of an alternative diagnosis that better explains the synovitis, and the achievement of a total score of at least 6 (of a possible 10) from the individual scores in four domains.\n\nThe highest score achieved in a given domain is used for this calculation. These domains and their values are:\n\n* Number and site of involved joints:\n\n  * 2 to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point\n  * 1 to 3 small joints (from among the MCP joints, PIP joints, second through fifth MTP joints, thumb IP joints, and wrists) = 2 points\n  * 4 to 10 small joints = 3 points\n  * Greater than 10 joints (including at least 1 small joint) = 5 points\n* Serological abnormality (RF or ACPA)\n\n  * Low positive (above the upper limit of normal) = 2 points\n  * High positive (greater than three times the upper limit of normal) = 3 points\n* Elevated acute phase response (ESR or CRP) above the upper limit of normal = 1 point\n* Symptom duration at least six weeks = 1 point\n\n  * Stable disease activity, defined as a RAPID-3 score of no higher than 4 over the past three months or no RA-related medication changes for at least six months prior to the informed consent date.\n  * Primary residence in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, and Hamilton counties).\n  * Established with the participating rheumatology clinic and a participating PCP (Note: For patients who are established in PCP clinics outside of the health system conducting this study, patients may see a participating PCP within their established clinic). To be considered an established patient, the participant should have had a visit within the year prior to the screening visit.\n  * Willingness to participate in the study and provide informed consent.\n  * Females of childbearing potential must agree to use highly effective birth control throughout duration of the study.\n\nExclusion Criteria:\n\n* Changes in RA treatment within the six months prior to screening.\n* History of interstitial lung disease or any manifestation of rheumatoid vasculitis including cutaneous rheumatoid vasculitis, vasculitic neuropathy, RA-associated episcleritis, scleritis or keratitis)\n* Cognitive impairment or inability to complete study assessments.\n* Pregnancy, breastfeeding, or plans to become pregnant during the study period.\n* Inability to adhere to the study protocol or follow-up requirements.\n* Any comorbid condition that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.",{"count":47,"type":19},100,"INTERVENTIONAL",[50],"NA","Rheumatoid arthritis (RA) is a complex autoimmune disease where the immune system attacks healthy joint tissue; causing pain, swelling, and stiffness of the joints. This disease effects lots of people in the US and can lead to major joint damage if not properly treated. In rural areas like northern NY, these are underserved areas for RA patients, thus many patients struggle to get the appropriate care. This model is testing whether primary care providers (PCP) can safely and effectively provide stable RA patients with the proper treatment rather than send them to a specialist. PCPs were trained through classes, case reviews, and a final exam. Patients will be randomly assigned to either see a trained PCP or their normal rheumatologist at the rheumatology clinic. This study will examine how patients are doing over a year using medical exams and patient feedback. If this model proves to be successful, it will make RA treatment easier and more affordable for patients.",[53],"Rheumatoid Arthritis (RA","RECRUITING","2025-06-13",{"date":57,"type":30},"2025-06-24",{"date":59,"type":19},"2025-06-26",{"date":61,"type":19},"2026-12-31",{"name":36,"class":37},""]