Interstitial Lung Disease Clinical Trial
Official title:
Patient-Reported Outcome Study of Project ECHO for ILD
NCT number | NCT05450276 |
Other study ID # | ILDC-003 |
Secondary ID | |
Status | Enrolling by invitation |
Phase | |
First received | |
Last updated | |
Start date | July 2022 |
Est. completion date | March 2024 |
Verified date | July 2022 |
Source | Pulmonary Care and Research Collaborative Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 56 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Pulmonary Care and Research Collaborative, Ltd. | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Pulmonary Care and Research Collaborative Limited | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 18 months | |
Primary | 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. | Up to 18 months | |
Secondary | 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. | Up to 18 months |
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