Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Other: Usual Care of IPF
* Other: Telenursing
* Other: Telenursing and Remote Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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. Willingness to participate in phone calls/video calls with the nurse practitioner or nurse case manager, if assigned to Arm 2 or Arm 3. Willingness to complete and monitor daily health assessments, if assigned to Arm 3. Willingness to share objective data via a provided electronic web-based portal, electronically via email, fax, or regular mail. Willingness to notify, or allow notification, of study involvement with local pulmonary practices. Exclusion Criteria: Diagnosed with any other interstitial lung disease. Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care of IPF<br>Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease | Other: Usual Care of IPF<br>* standard of care given to patients with IPF<br>|
| Experimental: Telenursing<br>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<br>* standard of care given to patients with IPF<br>Other: Telenursing<br>* scheduled phone calls with the patient and care giver<br>|
| Experimental: Telenursing and Remote Monitoring<br>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<br>* standard of care given to patients with IPF<br>Other: Telenursing<br>* scheduled phone calls with the patient and care giver<br>Other: Telenursing and Remote Monitoring<br>* scheduled phone calls and home monitoring of physiologic parameters<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of hospitalizations for respiratory illness | the number of times patients are hospitalized for a respiratory illness | Baseline to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of respiratory illnesses | the number of respiratory illnesses that occur in each arm | Baseline to 5 years | 
| the number of acute exacerbations | the number of acute exacerbations occurring in each arm by definition | Baseline to 5 years | 
| The length of time to first hospitalization for respiratory illness | The days from the date of diagnosis to the date of first hospitalization in each arm | Baseline to 5 years | 
| the presence and degree of dyspnea as measured by the modified Medical Research Council dyspnea score | a scale that measures the degree of shortness of breath at that time in each arm; range 0-4 with 0 being 'no shortness of breath' and 4 being 'maximal shortness of breath' | Baseline to 5 years | 
| the presence and degree of depression as measured by the Depression Self-screen | a questionnaire that scores patient-reported symptoms of depression in each arm; range 0-24 where 0-6 is none to mild depression and 16-24 is severe depression | Baseline to 5 years | 
| the presence and degree of anxiety as measured by the Anxiety Self-screen | a questionnaire that scores patient-reported symptoms of anxiety in each arm; range is 0-24, with 0-8 being none to mild anxiety and 16-24 is severe anxiety. | Baseline to 5 years | 
| the comparison of home spirometry to clinic-based spirometry | home-based spirometry measure of forced vital capacity (FVC) as compared to clinic-based FVC in the Telenursing with Remote Monitoring Arm | Baseline to 5 years |