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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
31
standard of care given to patients with IPF
scheduled phone calls with the patient and care giver
scheduled phone calls and home monitoring of physiologic parameters
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Number Hospitalization Events Resulting From a Respiratory Illness
The number hospitalization events resulting from a respiratory illness
Time frame: Baseline to 21 months
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
The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
The Number of Acute Exacerbations of IPF
Time frame: Baseline to 21 months
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
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
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.
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Time frame: Up to 21 months
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
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