Interstitial Lung Disease Due to Systemic Disease (Disorder)NCT07217093
Teleconsultation Approach to CTD-ILD Care Delivery in Rural UnderServed CommuniTies (TRUST Initiative)
An observational study of Interstitial Lung Disease Due to Systemic Disease (Disorder) and Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by St. Lawrence Health System at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease in Patients With Rheumatoid Arthritis, Interstitial Lung Disease Due to Systemic Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll up to 10 patients diagnosed with CTD-ILD who reside in the rural North Country region of New York. For the purpose of this study counties being, but not limited to, St. Lawrence, Franklin, Jefferson, Lewis, Hamilton, Clinton, and Essex counties.
Who may be able to join
- Age: Adults aged 18 years or older.
- 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
- 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)
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- 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)
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
St. Lawrence Health
Potsdam, New York, 13676
Autumn Thompson, 315-261-5611, autumn.thompson@rochesterregional.org
Eyal Kedar, MD
About this study
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.
The 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.
Read more
This 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.
By 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation Group | Patients will receive coordinated care with a regional rheumatologist, regional pulmonologist, and a teleconsultation with an interstitial lung disease specialist from Mayo Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
- Scores from a patient satisfaction survey to assess the perceived quality of teleconsultations-based care including assessments of quality and access to care, cost, and timesaving related to the teleconsultation model. Conducted at the baseline, 6 month, and 12 month visits.
Measured: 12 months
Secondary outcomes (6)
Healthcare Access Metrics
- Number and percentage of scheduled teleconsultation visits completed.
- Adherence rate of teleconsultation arm against their own historical data
Measured: 12 months
Care Coordination and Clinical Outcomes
- Frequency and nature of communication between local and teleconsulting providers.
Measured: 12 months
Dyspnea-12
Annual change in the Dyspnea-12 questionnaire (0-36) checked at months 0, 6, and 12
Measured: 12 months
Change in FVC
Annual change in FVC relative to the 24 months prior to enrollment.
Measured: 12 months
Change in DLCO
Annual change in DLCO relative to the 24 months prior to enrollment.
Measured: 12 months
ER Visits
Annual number of ER visits for CTD-ILD exacerbation, with comparison to two years of historical data, teleconsultation arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease Due to Systemic Disease (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Lawrence Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217093
- Sponsor's protocol ID
- EK-TRUST-01
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Douthit N, Kiv S, Dwolatzky T, Biswas S. Exposing some important barriers to health care access in the rural USA. Public Health. 2015 Jun;129(6):611-20. doi: 10.1016/j.puhe.2015.04.001. Epub 2015 May 27.
PubMed 26025176Adegunsoye A, Ryerson CJ. Diagnostic Classification of Interstitial Lung Disease in Clinical Practice. Clin Chest Med. 2021 Jun;42(2):251-261. doi: 10.1016/j.ccm.2021.03.002.
PubMed 34024401
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleconsultation Approach to CTD-ILD Care Delivery in Rural UnderServed CommuniTies (TRUST Initiative)
- ClinicalTrials.gov ID
- NCT07217093
- Acronym / sponsor ID
- EK-TRUST-01
- Conditions
- Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease in Patients With Rheumatoid Arthritis, Interstitial Lung Disease Due to Systemic Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Lawrence Health SystemUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
This 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.
By 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation Group | – | –Patients will receive coordinated care with a regional rheumatologist, regional pulmonologist, and a teleconsultation with an interstitial lung disease specialist from Mayo Clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll up to 10 patients diagnosed with CTD-ILD who reside in the rural North Country region of New York. For the purpose of this study counties being, but not limited to, St. Lawrence, Franklin, Jefferson, Lewis, Hamilton, Clinton, and Essex counties.
Key inclusion criteria (20 listed)
- Age: Adults aged 18 years or older.
- Diagnosis and Stable Condition:
- Residence:
- Active Care Relationship:
- o SLH-affiliated clinician
Key exclusion criteria (17 listed)
- 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.
- Participants with a life expectancy of less than six months due to any cause, as determined by the PI.
- 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.
- 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.
- Individuals currently participating in another interventional clinical trial for CTD-ILD or other chronic lung diseases that could interfere with the study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Satisfaction
Time frame: 12 months
a. Scores from a patient satisfaction survey to assess the perceived quality of teleconsultations-based care including assessments of quality and access to care, cost, and timesaving related to the teleconsultation model. Conducted at the baseline, 6 month, and 12 month visits.
6 secondary outcomes
Healthcare Access Metrics
Time frame: 12 months
Care Coordination and Clinical Outcomes
Time frame: 12 months
Dyspnea-12
Time frame: 12 months
Change in FVC
Time frame: 12 months
Change in DLCO
Time frame: 12 months
ER Visits
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Results publication: PubMed 26025176Douthit N, Kiv S, Dwolatzky T, Biswas S. Exposing some important barriers to health care access in the rural USA. Public Health. 2015 Jun;129(6):611-20. doi: 10.1016/j.puhe.2015.04.001. Epub 2015 May 27.
- Results publication: PubMed 34024401Adegunsoye A, Ryerson CJ. Diagnostic Classification of Interstitial Lung Disease in Clinical Practice. Clin Chest Med. 2021 Jun;42(2):251-261. doi: 10.1016/j.ccm.2021.03.002.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease Due to Systemic Disease (Disorder) and Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by St. Lawrence Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Autumn Thompson (315-261-5611, autumn.thompson@rochesterregional.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07217093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.