Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

Browse trials for

• Pulmonary Fibrosis 680
• Idiopathic Pulmonary Fibrosis 551
• Fibrosis 3,255

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 31 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Study arms

• 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

• 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 · Other: Telenursing

• 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 · Other: Telenursing · Other: Telenursing and Remote Monitoring

Interventions

• OtherUsual Care of IPF

  standard of care given to patients with IPF

• OtherTelenursing

  scheduled phone calls with the patient and care giver

• OtherTelenursing and Remote Monitoring

  scheduled phone calls and home monitoring of physiologic parameters

Primary outcomes

1. The Number Hospitalization Events Resulting From a Respiratory Illness

   The number hospitalization events resulting from a respiratory illness

   Time frame: Baseline to 21 months

Secondary outcomes

1. The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)

   The number of respiratory events that indicate a worsening of Idiopathic Pulmonary Fibrosis (IPF)

   Time frame: Baseline to 21 months

2. The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)

   The Number of Acute Exacerbations of IPF

   Time frame: Baseline to 21 months

3. The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness

   The total combined number of days for all participants in each arm from the date of IPF diagnosis to the date of first hospitalization for respiratory illness.

   Time frame: Baseline to 21 months

4. The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale

   Dyspnea (shortness of breath) was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).

   Time frame: Baseline to 21 months

5. The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool

   The adapted Mental Health America Depression Screening Tool is an 8 question self-administered questionnaire that scores patient-reported symptoms of depression. The possible score for each question ranges from 0-3. The total questionnaire score range is 0-24. Total scores of 0-6 indicate 'none to mild depression' and scores of 16-24 indicate 'severe depression'. Data from participant visits at baseline, 3 months, 9 months, 15 months and 21 months were combined and averaged to calculate a single value.

   Time frame: Up to 21 months

6. The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test

   The adapted New Zealand Health Promotion Agency Anxiety Self-Test is an 8 question self-administered questionnaire that scores patient-reported symptoms of anxiety. The possible score for each question ranges from 0-3. The total questionnaire score range is 0-24. Total scores of 0-8 indicate 'none to mild anxiety' and scores of 16-24 indicate 'severe anxiety'. Data from participant visits at baseline, 3 months, 9 months, 15 months and 21 months were combined and averaged to calculate a single value.

   Time frame: Baseline to 21 months

7. The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry

   The percentage of change in home-measured forced vital capacity (FVC) compared to clinic-measured FVC via spirometry

   Time frame: Baseline to 21 months

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Oct 26, 2018
• Informed consent form · Aug 31, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No