Purpose

Numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. It is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed patients with IPF will decrease hospitalizations for respiratory illness, increase compliance with therapies, and ultimately increase quality of life.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patient must be newly diagnosed with IPF by a Vanderbilt pulmonologist according to the 2011 American Thoracic Society Guidelines. If the patient has been diagnosed by local pulmonologist and started on FDA-approved treatment, then must have been started on treatment within 6 months of Vanderbilt University Medical Center-based diagnosis.
  2. Willingness to complete Quality of Life and Compliance Questionnaires at 6-month intervals either via an on-line process (RED Cap survey) or paper-based.
  3. Willingness to participate in phone calls/video calls with the nurse practitioner or nurse case manager, if assigned to Arm 2 or Arm 3.
  4. Willingness to complete and monitor daily health assessments, if assigned to Arm 3.
  5. Willingness to share objective data via a provided electronic web-based portal, electronically via email, fax, or regular mail.
  6. Willingness to notify, or allow notification, of study involvement with local pulmonary practices.

Exclusion Criteria

  1. Diagnosed with any other interstitial lung disease.
  2. Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Usual Care of IPF
Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease
  • Other: Usual Care of IPF
    standard of care given to patients with IPF
Experimental
Telenursing
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.
  • Other: Usual Care of IPF
    standard of care given to patients with IPF
  • Other: Telenursing
    scheduled phone calls with the patient and care giver
  • Other: Telenursing and Remote Monitoring
    scheduled phone calls and home monitoring of physiologic parameters
Experimental
Telenursing and Remote Monitoring
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.
  • Other: Usual Care of IPF
    standard of care given to patients with IPF
  • Other: Telenursing
    scheduled phone calls with the patient and care giver
  • Other: Telenursing and Remote Monitoring
    scheduled phone calls and home monitoring of physiologic parameters

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Wendi Mason, MSN
wendi.mason@vumc.org

More Details

NCT ID
NCT03562247
Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Wendi Mason, MSN
615-343-7068
wendi.mason@vumc.org

Detailed Description

Patients undergoing evaluation for and who are diagnosed with Idiopathic Pulmonary Fibrosis at Vanderbilt Medical Center from August 1, 2018, will be asked to participate. If agrees, and after signing the consent form, patients will be randomized into one of three arms: Usual Care, Usual Care with Telenursing, or Usual Care with Telenursing and Remote Monitoring. Patients will be asked to remain in the study for a minimum of three years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.