What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include the antifibrotic medications nintedanib and pirfenidone. Nintedanib is often associated with side effects such as diarrhea, nausea, and liver enzyme elevation. Pirfenidone commonly causes nausea, rash, and photosensitivity. Both medications aim to slow disease progression and reduce the frequency of acute exacerbations, but they do not cure the disease.

What prior FDA approvals exist?

The FDA has approved nintedanib and pirfenidone for the treatment of Idiopathic Pulmonary Fibrosis (IPF), both of which have been shown to slow disease progression. Additionally, inhaled treprostinil has been approved for patients with severe pulmonary hypertension due to advanced IPF. These treatments align with the goals of structured telenursing with home monitoring, which aims to improve patient outcomes through continuous remote assessment and management of respiratory function and oxygen levels.

What other types of research exist?

Promising alternatives to structured telenursing with home monitoring for IPF patients include: 1) The patientMpower app, which facilitates daily home-based spirometry and symptom monitoring via a mobile device, providing both objective and subjective data. 2) An internet-based remote spirometry system with smart device applications, which has shown to improve lung function and reduce complications in patients with multiple rib fractures, indicating potential applicability for IPF management.

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Telenursing for Pulmonary Fibrosis

N/A

Waitlist Available

Led By Lisa Lancaster, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 months

Awards & highlights

No Placebo-Only Group

Summary

This trial involves using remote nursing care and home health monitoring for patients newly diagnosed with Idiopathic Pulmonary Fibrosis. The goal is to reduce hospital visits, ensure patients stick to their treatments, and improve their quality of life. Patients will receive different types of care and be monitored over several years.

Who is the study for?

This trial is for newly diagnosed IPF patients who are willing to complete quality of life surveys, participate in remote calls with a nurse, and monitor daily health if required. They must have been diagnosed according to specific guidelines and started treatment within 6 months if not at VUMC.

What is being tested?

The study tests whether structured telenursing combined with home monitoring can reduce hospital visits, improve adherence to treatments, and enhance the quality of life for IPF patients compared to usual care.

What are the potential side effects?

Since this trial involves non-invasive monitoring and communication rather than medication or invasive procedures, there are no direct side effects associated with the interventions being tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Number Hospitalization Events Resulting From a Respiratory Illness

Secondary study objectives

The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)

The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness

The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Telenursing and Remote MonitoringExperimental Treatment3 Interventions

Patients will receive usual care with telenursing and will be given a hand held spirometer and puse oximeter and be asked to take daily measurements and report these via an electronic HIPAA approved secured platform for evaluation by the telenursing team.

Group II: TelenursingExperimental Treatment2 Interventions

Patients will receive usual care with structured phone calls from the nurse practitioner and/or case manager occuring more frequently earlier in the diagnosis to help the patient and care giver understand all aspects of the disease and it time will evolve to managing symptoms outside of out-patient clinic visits.

Group III: Usual Care of IPFActive Control1 Intervention

Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nintedanib and pirfenidone are the most common treatments for Idiopathic Pulmonary Fibrosis (IPF). Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, including those mediated by vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-derived growth factor (PDGF). Pirfenidone, on the other hand, has anti-inflammatory and antifibrotic properties, inhibiting the synthesis of transforming growth factor-beta (TGF-β) and tumor necrosis factor-alpha (TNF-α), which are key mediators in the fibrotic process. These treatments are crucial for IPF patients as they help slow disease progression and reduce the frequency of acute exacerbations, thereby potentially improving quality of life. Remote monitoring and telenursing can enhance the management of IPF by ensuring timely adjustments to therapy based on continuous assessment of respiratory function and oxygen levels.

Treatment of idiopathic interstitial pneumonias.