NCT05450276

Brief 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 study question.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

June 30, 2022

Last Update Submit

July 7, 2022

Conditions

Keywords

Progressive Fibrosing Interstitial Lung DiseaseIdiopathic Pulmonary FibrosisInterstitial Lung Disease Associated With Systemic SclerosisMyositis-Associated Interstitial Lung DiseaseSarcoidosisHypersensitivity PneumonitisPulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in patients' perceptions regarding local ILD care

    Up to 18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of pulmonologists and primary care physicians who participate in Project ECHO for ILD.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Care and Research Collaborative, Ltd.

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Lung Diseases, InterstitialIdiopathic Pulmonary FibrosisSarcoidosisAlveolitis, Extrinsic AllergicPulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aliaa Barakat, PhD

    Pulmonary Care and Research Collaborative, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 8, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations