Interstitial Lung DiseaseNCT05450276
Patient-Reported Outcome Study of Project ECHO for ILD
An observational study of Interstitial Lung Disease, run by Pulmonary Care and Research Collaborative Limited at 1 site in United States.
Trial summary
The study will assess whether patients of providers participating in Project ECHO for ILD experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, The study will employ nested mixed-method design at baseline, at 6 months and at 12 months to answer the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients of pulmonologists and primary care physicians who participate in Project ECHO for ILD.
Who may be able to join
- Confirmed diagnosis of interstitial lung disease
- Not be currently followed by an ILD specialist at an academic institution or must live more than 50 miles away from an academic ILD center
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary Care and Research Collaborative, Ltd.
Boston, Massachusetts, 02130
About this study
The study will assess whether patients of providers participating in Project ECHO for ILD experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, The study will employ nested mixed-method design at baseline, at 6 months and at 12 months to answer the study question.
Read the detailed description
Project ECHO (Extension for Community Healthcare Outcomes) is a knowledge-sharing model to expand the capacity of the health care workforce so that more people can get high quality care for their health conditions in or near the communities where they live. The model brings specialty disease expertise to community providers through its hub-and-spoke networks. The model relies on videoconferencing to connect local providers in non-urban or underserved communities (spoke sites) with an interdisciplinary team of specialist providers at academic medical centers (hubs) during virtual "teleECHO" clinic sessions, which include brief educational lectures and case-based, experiential learning.
The ECHO model addresses barriers of long wait times for a first appointment, the time and expense associated with long distance travel, and the disinclination to follow through on repeated care appointments in the face of these persistent barriers, all with the additional objective of achieving health equity. Most patients perceive the diagnostic and care pathways in ILDs as a major struggle because of lack of awareness about the diseases, delayed access to specialty centers, providers' focus on disease- versus patient-centered care, and lack of reliable information and education about the diseases and supportive care resources.
- Conditions
- Interstitial Lung Disease
- Keywords
- Progressive Fibrosing Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease Associated With Systemic Sclerosis, Myositis-Associated Interstitial Lung Disease, Sarcoidosis, Hypersensitivity Pneumonitis, Pulmonary Fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Alveolitis, Extrinsic Allergic, Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients' stress level
Assessed by the Perceived Stress Scale at baseline, 6 months, and at study end. The range of scores is 0-40, with higher scores indicating more appraised stress.
Measured: Up to 18 months
Patients' satisfaction of care
Assessed by the Patient Satisfaction Survey, a self-report scale assessing patient experience and satisfaction with local ILD care, which is composed of 28 items rated on a Likert Scale and Yes/No grading; the summed items produce a single satisfaction score.
Measured: Up to 18 months
Secondary outcomes (1)
Change in patients' perceptions regarding local ILD care
Patient participants in the study will complete interviews at baseline (their community PCP or pulmonologist attending their first ILD teleECHO clinic), at 6 months and at 12 months. The interviews will be open-ended to solicit the perspectives of participants regarding their experience with the local ILD care in their communities before, during and after their PCPs or local pulmonologists participate in Project ECHO for ILD.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmonary Care and Research Collaborative Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Aliaa Barakat, PhD, Principal investigator, Pulmonary Care and Research Collaborative, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450276
- Sponsor's protocol ID
- ILDC-003
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcome Study of Project ECHO for ILD
- ClinicalTrials.gov ID
- NCT05450276
- Acronym / sponsor ID
- ILDC-003
- Conditions
- Interstitial Lung Disease
- Keywords
- Progressive Fibrosing Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease Associated With Systemic Sclerosis, Myositis-Associated Interstitial Lung Disease, Sarcoidosis, Hypersensitivity Pneumonitis, Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Pulmonary Care and Research Collaborative LimitedUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 Jul 2022 (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.
The study will assess whether patients of providers participating in Project ECHO for ILD experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, The study will employ nested mixed-method design at baseline, at 6 months and at 12 months to answer the study question.
Detailed description
Project ECHO (Extension for Community Healthcare Outcomes) is a knowledge-sharing model to expand the capacity of the health care workforce so that more people can get high quality care for their health conditions in or near the communities where they live. The model brings specialty disease expertise to community providers through its hub-and-spoke networks. The model relies on videoconferencing to connect local providers in non-urban or underserved communities (spoke sites) with an interdisciplinary team of specialist providers at academic medical centers (hubs) during virtual "teleECHO" clinic sessions, which include brief educational lectures and case-based, experiential learning.
The ECHO model addresses barriers of long wait times for a first appointment, the time and expense associated with long distance travel, and the disinclination to follow through on repeated care appointments in the face of these persistent barriers, all with the additional objective of achieving health equity. Most patients perceive the diagnostic and care pathways in ILDs as a major struggle because of lack of awareness about the diseases, delayed access to specialty centers, providers' focus on disease- versus patient-centered care, and lack of reliable information and education about the diseases and supportive care resources.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of pulmonologists and primary care physicians who participate in Project ECHO for ILD.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of interstitial lung disease
- Not be currently followed by an ILD specialist at an academic institution or must live more than 50 miles away from an academic ILD center
Key exclusion criteria (1 listed)
- -
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
Change in patients' stress level
Time frame: Up to 18 months
Assessed by the Perceived Stress Scale at baseline, 6 months, and at study end. The range of scores is 0-40, with higher scores indicating more appraised stress.
Patients' satisfaction of care
Time frame: Up to 18 months
Assessed by the Patient Satisfaction Survey, a self-report scale assessing patient experience and satisfaction with local ILD care, which is composed of 28 items rated on a Likert Scale and Yes/No grading; the summed items produce a single satisfaction score.
1 secondary outcome
Change in patients' perceptions regarding local ILD care
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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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. This study is not recruiting at the moment.
Aliaa Barakat, PhD principal investigator
Pulmonary Care and Research Collaborative, Ltd.
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, run by Pulmonary Care and Research Collaborative Limited 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients' stress level (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2022.