Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

• ClinicalTrials.gov Identifier: NCT03562247
• Recruitment Status: Active, not recruiting
• First Posted: June 19, 2018
• Last Update Posted: February 8, 2021
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Lisa Lancaster, Vanderbilt University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Pulmonary Fibrosis	Other: Usual Care of IPF; Other: Telenursing; Other: Telenursing and Remote Monitoring	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: August 2025

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. The number of hospitalizations for respiratory illness [ Time Frame: Baseline to 5 years ]
   the number of times patients are hospitalized for a respiratory illness

Secondary Outcome Measures :

1. the number of respiratory illnesses [ Time Frame: Baseline to 5 years ]
   the number of respiratory illnesses that occur in each arm
2. the number of acute exacerbations [ Time Frame: Baseline to 5 years ]
   the number of acute exacerbations occurring in each arm by definition
3. The length of time to first hospitalization for respiratory illness [ Time Frame: Baseline to 5 years ]
   The days from the date of diagnosis to the date of first hospitalization in each arm
4. the presence and degree of dyspnea as measured by the modified Medical Research Council dyspnea score [ Time Frame: Baseline to 5 years ]
   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'
5. the presence and degree of depression as measured by the Depression Self-screen [ Time Frame: Baseline to 5 years ]
   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
6. the presence and degree of anxiety as measured by the Anxiety Self-screen [ Time Frame: Baseline to 5 years ]
   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.
7. the comparison of home spirometry to clinic-based spirometry [ Time Frame: Baseline to 5 years ]
   home-based spirometry measure of forced vital capacity (FVC) as compared to clinic-based FVC in the Telenursing with Remote Monitoring Arm

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Lisa Lancaster, MD; Vanderbilt University Medical Center

More Information

• Responsible Party: Lisa Lancaster, Professor of Medicine, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03562247
• Other Study ID Numbers: Tenure-1
• First Posted: June 19, 2018
• Last Update Posted: February 8, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases