Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

Vanderbilt University Medical Center

Status: Terminated

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Other: Telenursing; Other: Telenursing and Remote Monitoring; Other: Usual Care of IPF

Study type: Interventional

Funder types: Other

Identifiers

NCT03562247

Tenure-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Usual Care of IPF

Active Comparator group

Description:

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

Treatment:

Other: Usual Care of IPF

Telenursing

Experimental group

Description:

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.

Treatment:

Other: Usual Care of IPF

Other: Telenursing

Telenursing and Remote Monitoring

Experimental group

Description:

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.

Treatment:

Other: Usual Care of IPF

Other: Telenursing

Other: Telenursing and Remote Monitoring