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8110 Gatehouse Road, Falls Church, VA 22042

An Observational Study To Assess Disease-Relevant Outcomes Using Home Monitoring Devices In Patients With Idiopathic Pulmonary Fibrosis (STARMAP)

General Information

Age Group

Adult

Status

Active

Protocol Number

GA39831

Background Information

The overall objective of this study is to find out if the use of home-based mobile Health tools and patient-reported measures can give us a picture to see IPF progression and its impact on patients over time. This will be done by determining the usefulness and reliability of daily hand-held spirometry measurements, judging physical functional capacity as measured by a step-counting and sleep monitoring watch, and by observing other features of disease behavior (symptoms and quality of life) using patient-reported outcome (PRO) surveys.

Offered At

Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road, Falls Church, VA 22042

Principal Investigator

Steven Nathan, MD

Eligibility Information

  • Ability and willingness to provide electronically signed informed consent
  • Ability to comply with the study protocol, in the investigator's judgment
  • Ability to read and comprehend the English language (i.e., fluency and literacy in English)
  • Willingness to use and to wear the mHealth data collection devices
  • Age ≥ 40 years
  • Confirmed diagnosis of IPF based on review of relevant medical records by the Principal Investigator or qualified designee at the study center

Ineligibility Information

  • Any clinically significant medical disease or co-morbidities that would impair or risk the study patient’s full participation in the study (i.e., expected survival of <6 months)
  • Very severe IPF, defined as a FVC <45% of predicted
  • History of alcohol, drug, or chemical abuse that would impair or risk the patient’s full participation in the study
  • Requirement for continuous medical care and assistance or limited ability for self-care that would impact the ability of the patient to participate in the study or perform the study-related assessments
  • Patients receiving non-FDA-approved therapy for treatment of IPF within 4 weeks prior to screening