Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT07217093
Eligibility Criteria:
Inclusion Criteria:
1. Age: Adults aged 18 years or older.
2. Diagnosis and Stable Condition:
* Confirmed diagnosis of connective tissue disease-associated interstitial lung disease (CTD-ILD) by a physician based on clinical, radiographic, and/or 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.
* Diagnosis of CTD-ILD established at least one year prior to enrollment
3. Residence:
* 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)
4. Active Care Relationship:
* Documented diagnosis of CTD-ILD via any of the following:
o SLH-affiliated clinician
o Historical records
* Determination by PI
* Or an active SLH medical record (≥1 clinical encounter, test, or treatment in past 24 months)
5. Pulmonary Function Testing and safety labs:
* Ability and willingness to perform pulmonary function and safety lab tests at local facilities as required by the study protocol.
* Most recent PFT within 24 months prior to baseline
6. Consent:
* Provide written informed consent to participate in the study, including consent for data collection and telehealth consultations.
8\. Contraception
\- 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).
These 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.
Exclusion Criteria:
1\. Severe Cognitive or Mental Health Impairment:
* 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.
2\. Life Expectancy \< 6 Months:
* Participants with a life expectancy of less than six months due to any cause, as determined by the PI.
3\. Other Severe Pulmonary Diseases:
* 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.
4\. Inability to Perform Pulmonary Function Tests:
* 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.
5\. Active Participation in another Clinical Trial:
* Individuals currently participating in another interventional clinical trial for CTD-ILD or other chronic lung diseases that could interfere with the study outcomes.
6\. Significant Non-Compliance Risk:
* 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).
7\. Current ILD Treatment:
* 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.
8\. Pregnancy or Breastfeeding:
* Pregnant or breastfeeding women.
These 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07217093
Study Brief:
Protocol Section:
NCT07217093